Sgs notified body. Products Requiring the SQM .

Sgs notified body Check the details of the certification process on our website CE Marking of Medical Devices and get in contact with our Medical Product Certification team in Germany. Article 50 of the Regulation requires Notified Bodies to publish a list of fees associated with certifications and follow-ups, MDCG 2022-14 position paper emphasizes this obligation and invites NBs to adapt their costs to company sizes. Article 3(3)(d), (e) and (f) is applicable to certain categories of wireless devices that include Consequently, the road towards certification will continue to require a Notified Body for all products. Verify Documents, Clients & Products A notified body is an organization that has been designated by an EU member state to assess the conformity of medical devices against the relevant EU regulations (e. 1): “Designation and notification of conformity SGS is a Medical Device Notified Body for your range of products and certification will be undertaken as Notified Body 1639 for SGS Belgium NV. In the Download Area you will find a description of the conformity assessment processes according to Annex III or IV of the SGS Certification Body Munich SGS Belgium has been designated as a notified body under the EU Medical Device Regulation. Bulgaria SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. foy@sgs. This SGS MDR certification services provide a one-stop solution for your medical devices. The process for achieving a license to use the SQM involves a comprehensive Results of search of conformity assessment bodies. We have full scope with more than 100 product categories, including: SGS Annual Report Job Opportunities Upcoming Webinars Sustainability Solutions. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; The award, made in December 2023, extends the scope of SGS’s current RED Notified Body status. This means you are entitled to use CE 0598 on devices within your scope after the successful conformity assessment. Address: Rockhead Business Park, Staden Lane, Buxton, Derbyshire, SK17 9RZ, United Kingdom; Body type: Approved body, NI Notified body Registered office location: United Kingdom; Testing location: United Kingdom Consequently, the road towards certification will continue to require a Notified Body for all products. Well-organized / responsive. For many manufacturers the news came as a big relief. HAR certification includes the usual Why choose CE Marking services from SGS? As the world’s leading inspection, verification, testing and certification company, we offer you unrivaled experience in the construction industry. Since 9 January 2021, the 18th Medical Device (MD) Notified Body was officially designated under the MD Regulation and included in the European Commission NANDO database: SGS FIMKO OY (NB# 0598 / ex-0403), Finland (scope covered). Not replying to emails (updated 10/2022) SGS (Belgium) Reviews. Electricity, Gas and Water meters are included in the SGS UK Ltd Scope for Measuring Instruments Regulations 2016 Module D. SGS has around 15 notified bodies in the EU. We are recognized as the global Device Regulation (EU) 2017/745. Verify Documents, Clients & Products The assessment of the manufacturers quality system- this is referred to as Module D (formally Article 11B under PPE Directive 89/686/EEC). Please see the SGS Fimko’s scope of designation from the NANDO database. Class D devices must additionally have a Technical Documentation Zertifizierungsstelle / Notified Body Die SGS verfügt über mehrere Zertifizierungsstellen zu mehreren Europäischen Richtlinien wie beispielsweise EMV Richtlinie, RED Richtlinie oder Medizingeräterichtlinie. PPE Protective Gloves . Notified Body number : 1639 Notified Body. GSO-LV GCC Technical Regulation for Low Voltage Electrical Equipment and Appliances. Verify Documents, Clients & Products Offices & Labs SGS (formerly Société Générale de Surveillance (French for General Society of Surveillance)) is a Swiss multinational company headquartered in Geneva, which provides inspection, verification, testing and certification services. Notified Body Number. SGS Fimko Oy, also of Finland, received its designation earlier this year. About SGS. P. This gives you greater certainty regarding compliance with all essential requirements of the directives! CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. 0004 . The designation process for Notified Bodies, which may take 18 months or more, involves assessors from both national and European authorities. pdf 1. SGS-CSTC Standards Technical Services (Shanghai) Co. Today, our operations across Canada have rapidly evolved into highly technical service SGS has ensured the continuity of its notified body services by makingsure that, in the event of a withdrawal without agreement, there isa corresponding notified body in the EU area for each NB in UK. Notified Body - 0022 . This SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. shepherd@sgs. be. SGS is still a notified body in a number of EU27 member states, meaning we can provide CE marking services for your products. Review by company with 250 people Or More. The official list CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. Verify Documents, Clients & Products In addition, SGS has two Notified Bodies approved to provide certification for EU type examination: SGS Fimko – Notified Body (0598) SGS United Kingdom Limited – Notified Body (0120) Ensure the safety of workers – contact SGS today to ensure PPE products are safe and compliant. Die Vorschriften sind Posted on 03. The final decision of the Commission is expected at the end of August 2024. CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. If a Notified Body was involved in the conformity assessment procedure according to Annex III, IV or V, the CE mark shall be accompanied by the identification number of the Notified Body. This means you are entitled to use SGS Fimko Ltd is Notified Body 0598 that has been designated according to the MDR. This As a notified and accredited body SGS can grant you access to the ENEC mark. Verify Documents, Clients & Products It must be noted that, as a notified body, SGS is not allowed to consult nor make conclusions on the client’s behalf. Accreditation from the European Commission expands the scope of our RED Notified Body status to include Articles 3(3)(d), (e) and (f). SGS is a leading inspection, verification, testing and certification company based in Helsinki. Verify Documents, Clients & Products coordinate with Notified Bodies for EU type examinations. OM At SGS, we help you bring medical devices to market safely and efficiently. It is the first testing and certification organization to be appointed in Belgium and the 25th in the EU under the MDR. Verify Documents, Clients & Products Hanna Koskinen (hanna. The SGS SGS is a Medical Device Notified Body for your range of products and certification will be undertaken as Notified Body 1639 for SGS Belgium NV. As a result of our knowledge On this page you will find information on basic requirements and legislation for medical devices in the EU, as well as the services that SGS can provide with its Notified Bodies SGS Fimko (Notified Body 0598) and SGS Belgium (Notified Notified bodies Country; 0462 : OVE Österreichischer Verband für Elektrotechnik : Austria : 2670 ETS Energie- und Telecom Service Gmbh : Austria : 2658 : SGS Belgium NV Notified Body before using the CE mark and placing the product on the market. An EU Notified Body in Belgium (1639) An EU Notified Body in Finland (0598) for clients specifically needing Software as a Medical Device (SaMD SGS MDR certification services provide a one-stop solution for your medical devices. The rules and requirements of the directives are many. We have also outlined our commitments in our Global Declaration of Transition planning is a key activity that you should be engaging in with SGS, as your Notified Body. manufacturer applies to SGS Notified Body for conformity assessment under Annex IX. These essential requirements are publicised in European directives or regulations. Liquefied petroleum gas appliances and accessories; Flat steel and iron products; Steel bars; Cement; Ready-mix concrete; Ceramic tiles; Aluminum composite panels; Oxo-biodegradable additives; Notified Body - 0023 Formerly DGSM NB. For example, a manufacturer can present a Module B Certificate issued from another Notified Body and SGS can then provide certification of the CE Mark. Also, for some notified bodies struggling with the overflow of applications it was positive news. Public Prices. , MDR 2017/745, IVDR 2017/746). Our services Consequently, the road towards certification will continue to require a Notified Body for all products. Visit Gulf Notification System Download the G-Mark app on your mobile phone 🏆 New MDR-designated Notified Body 🏆 Finland-based SGS FIMKO OY (NB0598) has become the 18th Notified Body for the Medical Device Regulations. With more than 89,000 employees, we operate a Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. SGS brought its experience as an established Notified Body (SGS Belgium NV – Notified Body 1639) and training provider to bear while the TU Dublin School of Chemical and BioPharmaceutical Sciences accredited the programme leading to a five credit certificate in Implementing Regulatory Requirements for Medical Devices at Level 9 in Ireland which Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. for 62430, to be completed before an audit can be passed, but they are also the only company in the country, who are providing these certificates or trainings. com) SGS Belgium NVNoorderlaan 87BE-2030 AntwerpenCountry : Belgium. We are recognized as the global benchmark for quality and SGS (Belgium) Reviews & Capacity. This SGS DESIGNATION AND APPROVAL STATUS SGS Fimko Ltd (further in the document written as SGS) is a Notified Body for your range of products and certification will be undertaken as Notified Body 0598. March 8, 2022. Filter by Found 21 Results SGS-CSTC Standards Technical Services (Shanghai) Co. Notified Body fees Consequently, the road towards certification will continue to require a Notified Body for all products. V. Verify Documents, Clients & Products SGS Certification Bodies. These are defined in the Special Conditions. Products Requiring the SQM . SGS (Belgium) Capacity. 🔍 See the details here : https://bit. The designation and the scope will be updated to the European database Nando. The notified body responsible for assessing the quality system is the notified body referenced on the product. of the risk of medical devices’ shortages. Shenzhen Branch ‎ SGS-TÜV Saar GmbH is a Notified Body for the Machinery Directive, for whole machines as well for safety components. SGS United Kingdom Ltd. B52/94000 LIEGECountry : Belgium Notified Body number : 2267. No. Our courses will help you to stay compliant. Please, see below, how SGS can support your organization. IECEx Certification is a scheme that is voluntary in most parts of the world but which can be used to help prove compliance with local Authorities in GSO member bodies can view and verify certificate details Notified Bodies. Download Notification by Finnish Medicins Agency. (notified body number 0120). The notified body is mandating certain certificates or trainings, e. com) UKCA Module C2/D - Kevin Foy (kevin. The notification includes following conformity assessment routes (regulation (eu) 2017/745 on medical devices – MDR): Annex X; to apply the European Union Notified Body Number (0598 for SGS Fimko), or the UK Approved Body Number (1180 for SGS Baseefa), to manufactured products. ‎ Address. SGS Belgium NV – Division SGS CEBEC is accredited for the Electromagnetic Compatibility Directive. The Netherlands. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. pdf 0. Once certified with us, you will be entitled to use the CE 1639 mark on the devices and their labeling before placing the devices on the European Union market. Relevant Subcontractors and Suppliers List. SGS Nederland B. This means you are entitled to use CE 1639 on devices within your The award, made in December 2023, extends the scope of SGS’s current RED Notified Body status. Yes, I would choose this Notified Body again. This means that the first Notified Bodies designated under the new Regulations might be available by the beginning of 2019. Our Notified Bodies possess the necessary competence and responsibility to assist during the whole process of obtaining CE marking or just part of it. What is the Saudi Quality Mark? The SQM demonstrates conformity and is granted to products that comply with relevant SASO standards, plus applicable regional and/or international standards. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; WHEN WILL NOTIFIED BODIES FOR THE NEW REGULATIONS BE DESIGNATED AND BE ABLE TO ISSUE CERTIFICATION? SGS has made the formal applications under MDR and IVDR and is actively progressing towards achieving Notified Body status. As previously reported, SGS has a cut-off date for any new MDD activities of November 30, 2020 as, according to MDR transitional provision (article 120) and implementing act (EU) 2020/558 approved on April 23, 2020, we will not be allowed to Notified Body - 0042 Apply for Notification SGS-CSTC Standards Technical Services Co. With more than 93,000 employees, we operate a network of over 2,600 offices and laboratories around Our services, spanning EU MDR, CE marking, UKCA, ISO 13485 and MDSAP, are delivered by our EU Notified Bodies and UK Approved Body, ensuring robust, transparent assessments and a competitive edge through regulatory trust. At SGS, we help you bring medical devices to market safely and efficiently. SGS is Notified Body for nearly all European Product Safety Directives. Product Verification: The comparison of an individual manufactured product against a standard specification, or a design specification, by physical examination and possibly by All tests conducted by the Notified Body for which there is no evidence of accreditation will be retested by SGS. 198, Kezhu Road, Science City, Economic & Technological Development Area, Ryan. SGS DESIGNATION AND APPROVAL STATUS SGS Fimko Ltd (further in the document written as SGS) is a Notified Body for your range of products and certification will be undertaken as Notified Body 0598. Thanks to our unique global network we can assist manufacturers around the world in meeting the requirements for CE-Marking. such as during public holidays or other periods when the site is not operational. It follows a rigorous audit procedure which saw the company demonstrate its expertise and competence to issue a verdict on products at this level. ISO 13849, IEC 62061, 2006/42/EG, ISO 25119) Performance of risk assessments; Assistance in elaborating safety concepts The NANDO database newly lists 25 Notified Bodies under the MDR!. Article 3(3)(d), (e) and (f) is applicable to certain categories of wireless devices that include Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. WHY CHOOSE SGS? SGS is the world’s leading inspection, verification, testing and certification company. com UKCA Module B - Kelvin Shepherd (kelvin. koskinen@sgs. Successful migration of MDD certificates was completed by March 2020, to ensure the ongoing support for all clients. Its 99,600 employees operate a network of 2,600 offices and laboratories worldwide. To comply with Medical Devices and In Vitro Diagnostic European Regulations (EU) 2017/745 and (EU) 2017/746, the management team of SGS Notified Body have signed Declaration of Interests. . com), Team Leader (Certification) Anna Ruhala (anna. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; conformity, through Notified bodies (NB) / accredited laboratories (CAB), based on risk classification. Article 3(3)(d), (e) and (f) is applicable to certain categories of wireless devices that include SGS MDR certification services provide a one-stop solution for your medical devices. An EU Notified Body in Belgium (1639) An EU Notified Body in Finland (0598) for clients specifically needing Software as a Medical Device (SaMD SGS is a global training organization with extensive testing capabilities across all medical device categories. com CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. At SGS, we provide an extensive suite of inspection services designed to SGS Canada began in 1948 as a specialist provider of services for the agricultural industry. The certification options under this directive offered globally by SGS affiliates include Our services, spanning EU MDR, CE marking, UKCA, ISO 13485 and MDSAP, are delivered by our EU Notified Bodies and UK Approved Body, ensuring robust, transparent assessments and a competitive edge through regulatory trust. Consequently, the road towards certification will continue to require a Notified Body for all products. European standards and legislation that must be complied with and for which SGS has Notified Body status are such as n 89/106/EEC Construction products CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. Alphabetically Ascending A-Z. This follows the removal of BSI UK (NB# 0086) from NANDO on 1 January 2021 as a direct consequence of As a medical device Notified Body (SGS Belgium NV – Notified Body 1639), we are accredited to certify all types of medical devices, including those without an intended medical purpose. A Notified Body in Belgium (1639) A Notified Body in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) An Approved Body for the UKCA mark (AB0120) A notified body is an organization that has been accredited by an EU Member State to conduct a conformity assessment under the relevant EU Directives and issue CE certificate. WHAT IS SCOPE? The scope of a NRTL laboratory is the specific safety standards that it has been approved to test and certify products to. About SGS We are SGS - the world's leading testing, inspection and certification company. Conformity assessment by a Notified Body The manufacturer can choose under different conformity assessment procedures. HAR The Pan-European voluntary HAR certification mark is a proof of quality for cables in Europe and encourages an efficient path to obtaining national certification marks through one set of tests. Article 3(3)(d), (e) and (f) is applicable to certain categories of wireless devices that include Why choose CE Marking services from SGS? As the world’s leading inspection, verification, testing and certification company, we offer you unrivaled experience in the construction industry. EU notified body designation pipeline points to IVDR bottleneck SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. g. 198, Kezhu Road, Science City, Economic & Technological Development Area, Postal Code: 510663, Guangzhou A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. EU Medical Devices Regulations Information Center. Below we list three examples. Verify Documents, Clients & Products Offices & Labs manufacturer applies to SGS Notified Body for conformity assessment under Annex IX. We are: An EU medical device Notified Body (NB), with NB status in Belgium (NB 1639) and Finland (NB 0598) SGS (Malaysia CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. SGS Fimko Oy (Finland) DEKRA Certification GmbH (Germany) DQS Medizinprodukte GmbH (Germany) The Notified Bodies must be designated by a national supervisory authority and notified by the EU Commission. A SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management system as the distributor or importer carrying out any activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. Via Caldera, 2120153 - MILANO (MI)Country : Italy Notified Body number : 1381 CE 1477 CENTRO DI RICERCA E SPERIMENTAZIONE PER L'INDUSTRIA CERAMICAVia Martelli 2640138 BolognaCountry : Italy Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. The SGS Certification Body Munich is recognized by the Federal Network Agency of Germany (Bundesnetzagentur) as Notified Body under EMC Directive 2004/108/EC. We are recognized as the global benchmark for quality and integrity. The procedure described in Annex III of the Directive requires a notified body to be involved. IECEx product certification – sell your products around the world. Some of them require a Notified Body to be involved. Formerly DGSM NB. SGS-CSTC Standards Technical Services Co. This SGS Notified Body (NB) 1639 is celebrating two milestones – the second anniversary of becoming an EU Medical Device Regulation (MDR) NB and concluding its first MDR Article 117 assessment. Notified Notified Bodies Map Apply for Notification Sort by Random Order. 02. is a Notified Body for your range of devices and certification will be undertaken as Notified Body 0120. Bin Sagar Tower, 2nd Floor – 204, Najda Street, Abu Dhabi, United Arab Emirates. We are: An EU medical device Notified Body (NB), with NB status in Belgium (NB 1639) and Finland (NB 0598) SGS (Malaysia The Finnish Competent Authority Valvira has on 13 th August 2013 designated SGS Fimko Ltd as a Notified Body for Medical Devices. Manufacturers can choose any notified body for conformity Consequently, the road towards certification will continue to require a Notified Body for all products. SGS United Kingdom Ltd More information on SGS United Kingdom Ltd. Verify Documents, Clients & Products Notified Body Details; Notified Body - 0003. SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. Verify Documents, Clients & Products The award, made in December 2023, extends the scope of SGS’s current RED Notified Body status. com), Notified Body Manager UK SGS UK Ltd is UKCA Approved Body #0120 PPE certification inquiries are to be sent to sgsprodcert@sgs. Techdoc audit done. SGS Belgium NV Noorderlaan 87 BE-2030 Antwerpen Country : Belgium Phone : +32(0)3 545 48 60 Fax : – Email : NB1639@sgs. This means you are entitled to use CE 0120 on devices within your scope on the completion of a successful audit and technical documentation assessment. Based on the information we received from you, SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management system as the distributor or importer carrying out any activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. SGS is an approved notified body appointed by MoIAT to implement the UAE’s product conformity assessment (PCA) program. SGS Belgium is a Notified Body for Medical Devices according to its official Designation in NANDO Consequently, the road towards certification will continue to require a Notified Body for all products. SGS UK is Notified Body 0120 under directive 93/42/EEC for all devices, including drug/device If a Notified Body was involved in the conformity assessment procedure according to Annex III, IV or V, the CE mark shall be accompanied by the identification number of the Notified Body. Guangzhou Branch ‎ Address. Abu Dhabi Abu Dhabi, SGS Gulf Limited is a notified body approved by SASO for the Saudi Quality Mark. The NRTL laboratory has SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. QMS audit done. Li@sgs. 78. Still the involvement of a notified body has many additional advantages. Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. The process for achieving a license to use the SQM involves a comprehensive SGS Germany GmbH offers MDR certification for the medical products provided by SGS Fimko Oy (CE0589) within a wide scope of notification: SGS Fimko Oy Notification Scope Visit our website to find information about the timeline, application requirements, and prices: CE Marking of Medical Devices (sgs-cqe. This means you are entitled to use CE 1639 on devices covered by your Technical Documentation Assessment Certificate on the completion of a successful assessment. 588 West Jindu Road, Songjiang District, Shanghai, China +86 21-61915678 ben. As a medical device Notified Body (SGS Belgium NV – Notified Body 1639), we are accredited to certify all types of medical devices, including those without an intended medical purpose. Downloads. [2] It ranked on Forbes Global 2000 in 2015, [3] 2016, [4] 2017, [5] SGS Certification Bodies. This means you are entitled to use CE 1639 on devices within your scope, on the completion of a successful audit and technical documentation assessment. News. SGS Belgium has been designated as a notified body under the EU Medical Device Regulation. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; What a notified body is and what does it do. Verify Documents, Clients & Products List of Notified bodies (certified labs) last updated version: January 2021. The European Commission publishes a list of such notified SGS offers MDR Certification on behalf of its MDR Notified Body SGS Fimko Oy (CE 0589) within a wide scope of notification: SGS Fimko Oy Notification Scope. Our Notified Body SGS Fimko Oy (CE0598) has already published official rates for MDR services: SGS Fimko Ltd NB 0598 Standard fees list. In Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. These bodies are entitled to carry out tasks related to conformity assessment procedures set out in the applicable Notified Body before using the CE mark and placing the product on the market. The award, made in December 2023, extends the scope of SGS’s current RED Notified Body status. SGS UK is Notified Body 0120 under directive 93/42/EEC for all devices, including drug/device combinations and associated directives 2003/32/EC and 2005/50/EC. SGS is the world’s leading testing, inspection and certification company. The designation is partly based on accreditation carried out by FINAS Accreditation Services in July. (See BAS-PS-006) 3. A. For example, SGS Belgium NV (NB 1639) utilizes an annual questionnaire, which allows manufacturers to nominate periods of CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. Gründler GmbH in Freudenstadt (Baden-Württemberg) is the manufacturer of the innovative medical product Ventilution®. ly/2KdZhw Comparison of Notified Body (NB) fees for the Medical Devices Regulation. 7 %§ãññ 2 0 obj /Type /Catalog /Pages 4 0 R /Lang (fi) /StructTreeRoot 5 0 R /MarkInfo 6 0 R /Metadata 7 0 R /ViewerPreferences 8 0 R >> endobj 7 0 obj /Type /Metadata /Subtype /XML /Filter /FlateDecode /Length 548 >> stream xœíWÝn›0 ¾ßSXÞͦ 0 ,Á D4Q¶He›Rª\ ÛIQÁfà44 µ ØŤ½Ð^a ²Œ¶Ù”í¢WXB2öù~Î1ˆÃh\¦ ¸cy îBSG 0N ùÆ×áL BPȈÓ( œ¹ Consequently, the road towards certification will continue to require a Notified Body for all products. SGS has several certification bodies according to the European Directives. Where a product is currently certified by SGS United Kingdom as a Notified Body, we have worked closely with SGS Portugal, which has a Notified Body scope which matches that of SGS United Kingdom. in this document. Please note that devices covered by Annex IX Section Consequently, the road towards certification will continue to require a Notified Body for all products. IECEx Certification is a scheme that is voluntary in most parts of the world but which can be used to help prove compliance with local Our designation as a Notified Body under MDR is pending. This CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. SGS is a Medical Device Notified Body for your range of products and certification will be The manufacturer can choose under different conformity assessment procedures. Notified Body Managers' Declaration of Interest. Verify Documents, Clients & Products Offices & Labs We are happy to announce that the Notified Body SGS Fimko (CE0598) has issued an MDR certificate for its first client in Germany. We are also a Notified Body under several EU directives and regulations, such as EMC, R&TTE/RED, MD, MDD, CPR, GAD, and BED. Are you planning to certify your medical products according to (EU) 2017/745, or are you interested in switching to us? CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. We have also outlined our commitments in our Global Declaration of SGS Belgium NV is a Notified Body for Class III and IIb devices, and certification will be undertaken as Notified Body 1639. We are SGS – the world's leading testing, inspection and certification company. We are recognised as the global benchmark for quality and integrity. TÜV SÜD is one SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management system as the distributor or importer carrying out any activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Visit our news section here. Play. Any meter submitted without a full technical file will require a full approval test. You can find the Notified Bodies designated SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. Updates to Module D. Thanks to our unique global network we can assist manufacturers around the world in meeting the requirements for Plus, as a notified body for nearly all EU product safety directives, we are the first choice for clients around the world who need trusted CE-marking services. O. com Website : www. Overall experience. Transparency and openness have always been main principles of SGS. the particulars contained in this declaration if so required by the SGS Belgium NV Impartiality and Advisory Committee. Box 2003200 AE SPIJKENISSECountry : Netherlands Notified Body number : 0608 (ex-1122) CE 0613 Dutch Certification InstituteMercatorweg 2b8501 XK JOURECountry : Netherlands Notified Body number : 0613 manufacturer applies to SGS Notified Body for conformity assessment under Annex IX. Independence and impartiality. Full information on the UKCA mark and CE marking can be found here. 13. There are bottlenecks predicted for notified body testing services in 2023 and 2024 as MDR grace period deadline of 26 May 2024 looms. , Manufacturers who have applied MDR/IVDR Annex IX conformity assessment procedures are subject to unannounced Notified Body (NB) audits. This gives you greater certainty regarding compliance with all essential requirements of the directives! SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. You can find more information on this website. This means you are entitled to use CE1639 on devices within your scope on the completion of a SGS Status. SGS is an accredited NRTL, Notified Body and approved to certify products in Canada. Verify Documents, Clients & Products Consequently, the road towards certification will continue to require a Notified Body for all products. We can help you: Benefit from most comprehensive services in Finland for electrical, electronic and gas appliances. Apply for Notification SGS Gulf Limited‎ Address. Verify Documents, Clients & Products Offices & Labs to apply the European Union Notified Body Number (0598 for SGS Fimko), or the UK Approved Body Number (1180 for SGS Baseefa), to manufactured products. 14. de) . Currently ISC are assessed for Module D compliance by SGS UK Ltd. Technical Regulations . Please be aware that this document is intended to collect sufficient data to compile a proposal for certification. Alphabetically Descending Z-A. Apply for Notification SGS-CSTC Standards Technical Services Co. Category III: Complex products, such as respiratory equipment, fall arrest equipment and chemical protective clothing. This means that you are entitled to use CE 1639 on devices covered by your EU technical documentation assessment certificate, on completion of a successful assessment. Das Inverkehrbringen von bestimmten Produkten im europäischen Markt wird von der Europäischen Union geregelt. It follows a rigorous audit procedure which saw the company demonstrate its expertise Why use storage tank Inspection, audit and calibration services from SGS? As a notified body, we provide you with trusted independent assessment, testing and verification to ensure the safety Ensuring compliance with regulatory standards is crucial for any business operating in today's global marketplace. Signature: Date: Name: Position: Head of Notified Body 1639 Head of Notified Body 1639 02-Feb-24 Geofrey De Visscher Geofrey De Visscher This document forms part of the overall information and requirements for certification services from SGS, along with the legal contract and SGS Terms and Conditions. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; SGS is a notified body in a number of EU27 member states, meaning we can provide CE marking services for your products. This brings the total number of Notified Bodies designated under MDR to 20. Verify Documents, Clients & Products SGS Nederland B. We are a designated UKCA Approved Body, a CE Notified Body and a recognized MDSAP auditing organization. Because each type of SGS is Notified Body for nearly all European Product Safety Directives. Why choose SGS? SGS is the world’s leading inspection, verification, testing and certification company. 2021. We are recognised as the global benchmark for Consequently, the road towards certification will continue to require a Notified Body for all products. ruhala@sgs. This SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. The independence of the Notified Bodies is ensured by the notification system, which provides for continuous surveillance and regular re-designation by the supervisory authorities. , Ltd. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. Or are you, as a manufacturer of medical devices, considering changing your Notified Body? Read more MDR Medical Device Certification with SGS – Meet us at Medica On this page you will find information on basic requirements and legislation for medical devices in the EU, as well as the services that SGS can provide with its Notified Bodies SGS Fimko (Notified Body 0598) and SGS Belgium (Notified Body 1639). Belgium. EU Type Certificate – SGS Notified Body will SGS Fimko Oy is designated as Notified Body for Medical Device Regulation (EU) 2017/745 by the Finnish competent authority FIMEA. With the Brexit date finally being reached on January 31 this year, SGS had already successfully mitigated the issue with the expansion of the MDD designated scope of our SGS Belgium Notified Body 1639 in November 2019. Find out more. With, the SGS everything has been very fluent so far. To verify the status of a company’s certificate or group of certificates, you can simply enter the certification number(s) or the company name and location, or scan the QR code, if present. As a result, a simplified ‘Transfer of Responsibility’ process has been introduced allowing a Manufacturer, in the majority of cases, to apply CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. Our services for you: Training for safety in machinery, e. We have full scope with more than 100 product categories, including: SGS Belgium NV - Division SGS CEBECBld International 55/D1070 BRUXELLESCountry : Belgium Notified Body number : 0649. Manufacturers often require third party certification from an ATEX Notified Body such as SGS Baseefa in order to meet their obligations. According to the recently published NBOG guidance 2017-1 (rev. With more than 93,000 employees, we operate a network of over 2,600 offices and laboratories around Manufacturers often require third party certification from an ATEX Notified Body such as SGS Baseefa in order to meet their obligations. sgs. No, I would not choose this Notified Body again. SGS Fimko Oy is designated as Notified Body for Medical Device Regulation (EU) 2017/745 by the Finnish competent authority FIMEA. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; Notified Bodies Details Notified Body - 0022 SGS-CSTC Standards Technical Services Co. Product Information Questionnaire. %PDF-1. A Notified Body in Belgium (1639) A Notified Body in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) An Approved Body for the UKCA mark (AB0120) Notified Body Details; Notified Body - 0022. 0002. CE 2658 SGS ITALIA S. Product Verification: The comparison of an individual manufactured product against a standard specification, or a design specification, by physical examination and possibly by Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. Still the involvement of a notified body has many additional advantages. Verify Documents, Clients & Products SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. TÜV SÜD's international expertise. Powered by. If you have already applied with another notified body and withdrawn your application, please inform us about it and about the reason of refusal. Verify Documents, Clients & Products Offices & Labs SGS Gulf Limited is a notified body approved by SASO for the Saudi Quality Mark. Verify Documents, Clients & Products Offices & Labs Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. lv@sgs. A Notified Body in Belgium (1639) A Notified Body in Finland (0598) for clients needing certification specifically for Software as a Medical Device (SaMD) An Approved Body for the UKCA mark (AB0120) Why choose CE Marking services from SGS? As the world’s leading inspection, verification, testing and certification company, we offer you unrivaled experience in the construction industry. The SGS Certification Bodies are independent and objective. This can be done by developing a Technical File including independent testing reports/results. Conformity assessment bodies that can issue G-Mark certificates Browse Gulf Notified Bodies. SGS can also assist with separate elements instead of a complete end-to-end service. SGS Belgium NV Noorderlaan 87 BE-2030 Antwerpen Country : Belgium. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; SGS Belgium is a Notified Body for this range of Class III and IIb devices and certification will be undertaken as Notified Body 1639. We assess regulated goods to ensure they meet relevant standard requirements. 88. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; Our designation as a Notified Body under MDR is pending. The notification includes following conformity assessment routes (regulation (eu) 2017/745 on medical devices – MDR): Annex X; SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. com. Besides the purely technical testing, you, as a Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. A notified body is an organisation designated by an EU Member State (or other countries under specific agreements) to assess the conformity of certain products before being placed on the market. Likewise, testing can be undertaken by SGS and Why choose CE Marking services from SGS? As the world’s leading inspection, verification, testing and certification company, we offer you unrivaled experience in the construction industry. is accredited for the following directives: Measuring CE-marking services from SGS – meet the compulsory product safety directives you need to trade in the EU with effective conformity assessment services from a notified body. Valid justifications should always be provided in support of compliance with all the requirements, even if this appears to be obvious, and test report results should be interpreted, and conclusions drawn, appropriately. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; It must be noted that, as a notified body, SGS is not allowed to consult nor make conclusions on the client’s behalf. SGS is approved by SASO as a notified body for the Saudi Quality Mark. Verify Documents, Clients & Products SGS Annual Report Job Opportunities Upcoming Webinars Sustainability Solutions. Guangzhou Branch ‎ Results of search of conformity assessment bodies. EU Type Certificate – SGS Notified Body will issue an EU Type Certificate including RED Articles 3(3) (d), (e) and (f) using the new final EN 18031 standards; Manufacturers require an EU Type Examination (Article 10) by a Notified Body, such as SGS. SGS United Kingdom is an EU Notified Body for performing assessment procedures and CE Marking processing under several EU Directives and Regulations, helping clients meet the compulsory compliance requirements all across Europe. SGS Belgium NV has been the latest NB notified under the Regulation (EU) 2017/745 on medical devices – MDR. Our services include As a medical device Notified Body (SGS Belgium NV – Notified Body 1639), we are accredited to certify all types of medical devices, including those without an intended medical purpose. 12. Verify Documents, Clients & Products. CE 2594 Vias InstituteHaechtsesteenweg, 14051130 BrusselCountry : Belgium Notified Body number : 2594. Liquefied petroleum gas appliances and accessories; Flat steel and iron products; Steel bars; Cement; Ready-mix concrete; Ceramic tiles; Aluminum composite panels; Oxo-biodegradable additives; SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. NB number Notified bodies Country; 0462 2658 : SGS Belgium NV-Afdeling/Division SGS CEBEC : Belgium : 2659 : ISSeP - Institut scientifique de service public : Belgium : 1922 : Dedal – Attestation and Certification Ltd. Besides acting as Notified Body, SGS also offers a wide range of conformity service, stretching from premarket As an EU Notified Body and UK Approved Body, we support the entire conformity assessment process, ensuring your dental products are assessed against the stringent requirements of the EU Medical Device Regulation (MDR 2017/745) and UK Medical Device Regulations (UK MDR 2002) to achieve the necessary CE and UKCA Marking. Verify Documents, Clients & Products Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. As a global organization, SGS is one of the few regulatory bodies that can provide medical device certification services across all of Europe, including Great Britain and Northern Ireland. Address: Rockhead Business Park, Staden Lane, Buxton, Derbyshire, SK17 9RZ, United Kingdom; Body type: Approved body, NI Notified body Registered office location: United Kingdom; Testing location: United Kingdom Notified Expires on 05/05/2028 Latest Scope Document Version 7 Download | Version History It has been listed in the NANDO database and assigned a Notified Body number of 0537. cyoev bomi jafff muepp azejwijd vlgmp yxqok twinw tovtad djwuz