Sgs notified body. devices under self-certification).

Sgs notified body Notified Body that has the ability to perform on-site lab tests include: SGS; TÜV Jun 10, 2020 · SGS United Kingdom. Oct 2, 2017 · SGS is still a notified body in a number of EU27 member states, meaning we can provide CE marking services for your products. EU notified body designation pipeline points to IVDR bottleneck SGS SERVICE Covering the full range of PPE, we offer: • Product testing • Category II & III certification • SGS FIMKO (NB0598) – Notified Body to PPE Regulation (EU) 2016/425 • Mesh eyeSGS UK (0120) – Approved Body to PPE Regulation 2016/425 as brought into GB law and amended • One-stop-shop service for CE and UKCA certification Dec 14, 2020 · Some Notified Bodies may also have the ability to perform the necessary product lab testing, and issue the related test reports. With more than 93,000 employees, we operate a network of over 2,600 offices and laboratories around 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. com UKCA Module B - Kelvin Shepherd (kelvin. 1): “Designation and notification of conformity 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. Until 31 December 2020, certification continued as before with certificates issued by UK Notified Bodies remaining valid in the EU and certificates issued by EU Notified Bodies remaining valid in the UK. WHY CHOOSE SGS? SGS is the world’s leading inspection, verification, testing and certification company. The Commission publishes a list of designated SGS Nederland B. Verify Documents, Clients & Products Offices & Labs 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. Examining the technical design and testing the product according to relevant technical specifications under the applicable regulation(s) b. 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. com), Team Leader (Certification) Anna Ruhala (anna. Signature: Date: Name: Position: Head of Notified Body 1639 Head of Notified Body 1639 02-Feb-24 Geofrey De Visscher Geofrey De Visscher SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. Full information on the UKCA mark and CE marking can be found here. SGS Fimko – Notified Body (0598) SGS United Kingdom Limited – Notified Body (0120) We also provide annual factory audits for Category III products through our global auditor network. We are recognized as the global benchmark for quality and integrity. com Tel : +44 (0)121 541 4743. Below we list three examples. Reviewing compliance documentation 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. The rules and requirements of the directives are many. The manufacturer can usually choose under different conformity assessment procedures. S. SGS-TÜV Saar GmbHAm TÜV 166280 SULZBACHCountry : Germany Notified Body number : 1637 CE 1644 PfB GmbH & Co. Nov 30, 2021 · Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. Our Notified Bodies possess the necessary competence and responsibility to assist during the whole process of obtaining CE marking or just part of it. shepherd@sgs. 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. V. This the particulars contained in this declaration if so required by the SGS Belgium NV Impartiality and Advisory Committee. To support hospitals and patients during this difficult period. Besides the purely technical testing, you, as a manufacturer, are responsible for the proper technical documentation and the correct labeling of your products. For more information, pleasecontact: When a medical device is of higher risk class than class I, conformity to regulations must be assessed by a Notified Body. 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. Our services 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. The final decision of the Commission is expected at the end of August 2024. Since medical devices and manufacturers vary greatly, we cannot give you an estimate of the turnaround time or cost for the certification project without an application review. Supplying expert knowledge towards medical device certification. Some of them require a Notified Body to be involved. Sep 12, 2022 · Comparison of Notified Body (NB) fees for the Medical Devices Regulation. com), Notified Body Manager UK SGS UK Ltd is UKCA Approved Body #0120 PPE certification inquiries are to be sent to sgsprodcert@sgs. The award, made in December 2023, extends the scope of SGS’s current RED Notified Body status. Jun 20, 2022 · Notified Body. To sell gloves as Category II PPE, to protect against mechanical risks, they must meet the EN 388 and EN 420 standards. n°: 04 Page 1 of 5 SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. ruhala@sgs. devices under self-certification). Notified Bodies. (notified body number 0120). ISO 13849, IEC 62061, 2006/42/EG, ISO 25119) Performance of risk assessments; Assistance in elaborating safety concepts Nov 29, 2021 · Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. Why choose PPE testing and certification from SGS? Dec 20, 2023 · SGS Fimko Ltd (SGS), in Finland, gained accreditation for Article 3(3)(d), (e) and (f) which sets out to protect privacy and personal data, and minimize fraud. In May 2021, the Medical Device Regulation (MDR) officially replaced the Medical Device Directive (MDD) with the aim to enhance safety for European See full list on sgs-certification-body. Mar 30, 2022 · SGS (Belgium) Reviews & Capacity. Focus on quality and safety management for your medical devices with SGS’s training for ISO 13485 certification and implementation. n°: 04 Page 1 of 5 SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management SGS Belgium NV-Afdeling/Division SGS CEBECRiverside Business Park Internationalelaan/Bld International 55D1070 Brussel/BruxellesCountry : Belgium Notified Body number : 2658 CE 2659 ISSeP - Institut scientifique de service publicRue de Chéra 2004000 LiègeCountry : Belgium Notified Body number : 2659 On January 6, 2023, the EU Commission adopted a proposal to allow more time to certify medical devices according to Regulation (EU) 2017/745. Gründler GmbH in Freudenstadt (Baden-Württemberg) is the manufacturer of the innovative medical product Ventilution®. SGS Fimko Oy, also of Finland, received its designation earlier this year. is accredited for the following directives: Measuring At SGS, we help you bring medical devices to market safely and efficiently. The Netherlands. It has been listed in the NANDO database and assigned a Notified Body number of 0537. This means that the first Notified Bodies designated under the new Regulations might be available by the beginning of 2019. A. Accreditation from the European Commission expands the scope of our RED Notified Body status to include Articles 3(3)(d), (e) and (f). You can find the Notified Bodies designated Zertifizierungsstelle / Notified Body Die SGS verfügt über mehrere Zertifizierungsstellen zu mehreren Europäischen Richtlinien wie beispielsweise EMV Richtlinie, RED Richtlinie oder Medizingeräterichtlinie. BREXIT & Certification Today – 8 January 2021. Liquefied petroleum gas appliances and accessories; Aug 6, 2024 · Consequently, the road towards certification will continue to require a Notified Body for all products. 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. The procedure described in Annex III of the Directive requires a notified body to be involved. We are recognised as the global benchmark for quality and integrity. 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. The SGS Certification Body Munich is recognized by the Federal Network Agency of Germany (Bundesnetzagentur) as Notified Body under EMC Directive 2004/108/EC. foy@sgs. Aug 6, 2024 · Consequently, the road towards certification will continue to require a Notified Body for all products. According to the recently published NBOG guidance 2017-1 (rev. Product Verification: The comparison of an individual manufactured product against a standard specification, or a design specification, by physical examination and possibly by They may not in any way be disclosed, copied or used by anyone except as expressly authorized by SGS. n°: 06 Page 1 of 8 SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. After MDR’s Date of Application, from 26 May 2021 the assessment must take place according to the rules of MDR. Successful migration of MDD certificates was completed by March 2020, to ensure the ongoing support for all clients. Products Requiring the SQM . Verify Documents, Clients & Products Offices & Labs SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for Class III and IIb devices, and certification will be undertaken as Notified Body 1639. 3 (d Hanna Koskinen (hanna. As a Notified Body, SGS has focused its resources on supporting manufacturers of COVID -19 related devices – ventilators, CT scanners – to help them get their products to market quickly (in collaboration with the European Competent Authority) and provide They may not in any way be disclosed, copied or used by anyone except as expressly authorized by SGS. SGS Fimko Ltd is Notified Body 0598 that has been designated according to the MDR. Manufacturers, or their authorized representatives, in the European Community must also submit technical documentation, including product samples for testing, to a Notified Body for EU type examination under the EU’s Personal Protective Equipment (PPE) Regulation, 2016/424. com) UKCA Module C2/D - Kevin Foy (kevin. SGS is a notified body in a number of EU27 member states, meaning we can provide CE marking services for your products. Designation of a notified body. SGS Annual Report Job Opportunities Upcoming Webinars Sustainability Solutions EU Medical Devices Regulations Information Center Here you will find some important documents to guide you in an application for certification against the new Medical Devices Regulation and In Vitro Diagnostic Medical Device Regulation. This American National Standards Institute (ANSI) has notified the U. Visit Gulf Notification System Apr 14, 2020 · The assessment of the manufacturers quality system- this is referred to as Module D (formally Article 11B under PPE Directive 89/686/EEC). IECEx product certification – sell your products around the world. Dec 5, 2023 · 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. Food and Drug Administration that SGS North America Inc. 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. 3 (d SGS ITALIA S. We are happy to announce that the Notified Body SGS Fimko (CE0598) has issued an MDR certificate for its first client in Germany. This means you are entitled to use CE 0598 on devices within your scope after the successful conformity assessment. You can find more information on this website. There you will also find the application form for a Notified Body assessment by us. Why choose SGS? SGS is the world’s leading inspection, verification, testing and certification company. Dec 20, 2023 · SGS is pleased to announce its accreditation by the European Commission as a Notified Body for the latest delegated act of the Radio Equipment Directive (RED) (2014/53/EU) designed to strengthen the cybersecurity of wireless devices available in the EU. With specialists worldwide, we ensure your compliance with diverse international standards. About SGS We are SGS - the world's leading testing, inspection and certification company. 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. Our experts deliver a wide range of standard and non-standard tests on medical devices and certify them through our notified bodies. Dec 1, 2021 · SGS Belgium has been designated as a notified body under the EU Medical Device Regulation. SGS United Kingdom branch started its operation in 1974. Notified bodies Country; 0462 : OVE Österreichischer Verband für Elektrotechnik : Austria : 2670 : ETS Energie- und Telecom Service Gmbh : Austria : 2658 : SGS Belgium NV-Afdeling/Division SGS CEBEC : Belgium : 2659 : ISSeP - Institut scientifique de service public Apr 17, 2020 · SGS Status. n°: 04 Page 1 of 5 SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management Feb 5, 2024 · If a notified body is involved, it is the notified body that “grants” the CE marking for the product. (See BAS-PS-006) 3. Verify Documents, Clients & Products The designation process for Notified Bodies, which may take 18 months or more, involves assessors from both national and European authorities. 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. Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. March 8, 2022. SGS has around 15 notified bodies in the EU. P. Our services for you: Training for safety in machinery, e. So, basically they are forcing us to buy their products (which are not cheap). ECAS and EQM – certification Scheme Hanna Koskinen (hanna. SGS SAFETY MARK The global SGS Product Safety mark allows you to prove that your product fulfils all relevant Product Safety requirements applicable on the market of your interest. de 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. SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for Class III and IIb devices, and certification will be undertaken as Notified Body 1639. koskinen@sgs. g. 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. Verify Documents, Clients & Products Offices & Labs. It must be noted that, as a notified body, SGS is not allowed to consult nor make conclusions on the client’s behalf. These are defined in the Special Conditions. 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. Mar 15, 2021 · SGS Fimko Oy has been designated as a notified body according to MDR (EU) 2017/745. After certification, qualifying products must display the CE Mark. Prüfzentrum für Bauelemente KGLackermannweg 2483071 StephanskirchenCountry : Germany Notified Body number : 1644 Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. 3 (d They may not in any way be disclosed, copied or used by anyone except as expressly authorized by SGS. Designated scope - types of medical devices for which the approved body is permitted to issue UKCA certification: Jun 12, 2024 · SGS is an approved notified body appointed by MoIAT to implement the UAE’s product conformity assessment (PCA) program. Belgium. O. Notified Body fees Manufacturers often require third party certification from an ATEX Notified Body such as SGS Baseefa in order to meet their obligations. The official list of the notified body status of the of SGS Fimko is available on NANDO. com) 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. Rev. We assess regulated goods to ensure they meet relevant standard requirements. Conformity assessment bodies that can issue G-Mark certificates Browse Gulf Notified Bodies. This brings the total number of Notified Bodies designated under MDR to 20. 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 Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. 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 Nederland B. About SGS. This decision is aimed at mitigation of the risk of medical devices’ shortages. The forms for application for MDR certification with the Notified Body SGS Fimko Oy [Link] are also available here. SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. in this document. There are bottlenecks predicted for notified body testing services in 2023 and 2024 as MDR grace period deadline of 26 May 2024 looms. This 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) An Approved Auditing Organization (AO) for MDSAP; We provide: Training courses to help you understand the new requirements Nov 30, 2021 · Head of Notified Body 1639, Certification Knowledge Solutions t: +32 3 545 48 60. Mar 17, 2019 · 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. SGS Belgium NV – Division SGS CEBEC is accredited for the Electromagnetic Compatibility Directive. 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. It is the first testing and certification organization to be appointed in Belgium and the 25th in the EU under the MDR. Please feel free to contact us for further information. The notified body responsible for assessing the quality system is the notified body referenced on the product. Review by company with 250 people Or More. At SGS, we help you bring medical devices to market safely and efficiently. Nov 30, 2021 · We are pleased to confirm that our Belgian Notified Body has been designated by the European Commission and Belgian Competent Authority (FAMHP) under Medical Device Regulation (EU) 2017/745. TÜV SÜD is one FOR PRODUCTS WHERE CE CERTIFICATION BY NOTIFIED BODY SGS, ACCORDING TO REGULATION (EU) 2017/745, IS SOUGHT This document should not be completed for devices that do not need a CE certificate from a Notified Body (e. Dec 20, 2023 · SGS Fimko Ltd (SGS), in Finland, gained accreditation for Article 3(3)(d), (e) and (f) which sets out to protect privacy and personal data, and minimize fraud. 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. The designation was achieved after years of tough assessment process, performed by multinational authorities The designation was long-awaited endpoint after years of tough assessment process, performed by multinational authorities. Email: UKCAmedicalAB0120@sgs. com) Sep 28, 2020 · COVID-19 Pandemic News. In the past two years, more than 200 experts in CEN-CENELEC JTC13/WG8 have been working on the EN 18031 series of harmonized standards that cover RED article 3. 3 (d Nov 14, 2024 · Contact: Lynn Henderson. Verify Documents, Clients & Products Offices & Labs Dec 6, 2021 · SGS in Spain has been endorsed by the Spanish national accreditation body (ENAC) to act as an Independent Notified Body for the assessment of control-command and signaling systems against the European technical specifications for interoperability (TSI NoBo). The rules for designating Notified Bodies are also more rigorous and add new requirements and responsibilities. SGS contributes to the fight against COVID-19. The Finnish Competent Authority Valvira has on 13 th August 2013 designated SGS Fimko Ltd as a Notified Body for Medical Devices. COMPLETION GUIDANCE NOTES 1. When a medical device is of higher risk class than class I, conformity to regulations must be assessed by a Notified Body. SGS (Belgium) Capacity No, I would not choose this Notified Body again. This Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. 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. Verify Documents, Clients & Products Offices & Labs Nov 21, 2024 · Some CABs (including the notified body of SGS) have additional provisions in the client agreements allowing the individual audit or technical documentation review completely closed with a negative result if it is clear that the documentation is not ready for the assessment; in this case the manufacturer has to restart the failed part of the 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. However, not every Notified Body has the ability or proper facilities to carry out lab tests on behalf of manufacturers and importers. (SGS FimkoNB 0598). Box 2003200 AE SPIJKENISSECountry : Netherlands Notified Body number : 0608 (ex-1122) CE 0613 Dutch Certification InstituteMercatorweg 2b8501 XK JOURECountry : Netherlands Notified Body number : 0613 Mar 1, 2022 · The notified body is mandating certain certificates or trainings, e. The UK left the EU on Friday 31 January 2020. 3 (d 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. On this page you will find information on the basic requirements and legislation of medical device in the EU, and the services that SGS Fimko as a Notified Body can offer. This They may not in any way be disclosed, copied or used by anyone except as expressly authorized by SGS. 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. We are SGS – the world's leading testing, inspection and certification company. Signature: Date: Name: Position: Head of Notified Body 1639 Head of Notified Body 1639 02-Feb-24 Geofrey De Visscher Geofrey De Visscher Title: Medical Device Regulation (MDR) Readiness Checklist Subject: Medical Device Regulation (MDR) Readiness Checklist Keywords: Medical Device Medical Devices Medical Device Regulation MDR Medical Device Directive MDD Medical Devices Pre-Audit Questionnaire Notified Body Notified Body SGS Belgium SGS Manufacturer Manufacturing Medical Device Manufacturer Medical Device Manufacturing MDR FOR PRODUCTS WHERE CE CERTIFICATION BY NOTIFIED BODY SGS, ACCORDING TO REGULATION (EU) 2017/745, IS SOUGHT This document should not be completed for devices that do not need a CE certificate from a Notified Body (e. 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 Notified Body number : 1477 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. n°: 04 Page 1 of 5 SGS DESIGNATION AND APPROVAL STATUS SGS Belgium NV is a Notified Body for your products and certification will be undertaken to attest that your quality management INTERNATIONAL MARKS As a notified and accredited Certification Body (CB) SGS operates one of the largest Safety & EMC testing & certification networks in the world. Still the involvement of a notified body has many additional advantages. Search SGS’s directories of certified clients and products to verify the status of management system, process or product certificates we have issued, as well as finding key data on audited suppliers. 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) An Approved Auditing Organization (AO) for MDSAP; We provide: Training courses to help you understand the new requirements the particulars contained in this declaration if so required by the SGS Belgium NV Impartiality and Advisory Committee. 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. To be designated, a candidate organisation must fulfil specific requirements on organisational aspects, quality management, resources and processes verified by national authorities responsible for notified bodies with the involvement of other European experts. The designation is partly based on accreditation carried out by FINAS Accreditation Services in July. Aug 5, 2024 · Consequently, the road towards certification will continue to require a Notified Body for all products. SGS Belgium is a Notified Body for Medical Devices according to its official Designation in NANDO SGS is approved by SASO as a notified body 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. of Rutherford, NJ has become a certification body (CB) accredited under SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. The tasks performed by the notified body include the following: a. They may not in any way be disclosed, copied or used by anyone except as expressly authorized by SGS. Powered by. Our experienced experts and specialized laboratories worldwide can support every step of your compliance journey, even for technologically sophisticated The manufacturer can choose under different conformity assessment procedures. TÜV SÜD's international expertise. 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. After certification manufacturers can affix CE Mark on their Medical device and are free to market their devices in all EU Member states. Verify Documents, Clients & Products Offices & Labs SGS-TÜV Saar GmbH is a Notified Body for the Machinery Directive, for whole machines as well for safety components. 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. 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. Currently ISC are assessed for Module D compliance by SGS UK Ltd. The process of designating Notified Bodies will take up a significant part of the transition period, meaning that there will be limited time for manufacturers to get all their products certified before the respective DoAs. With more than 93,000 employees, we operate a network of over 2,600 offices and laboratories around SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. Open to all retailers, manufacturers, consumers and other stakeholders, our directories can be searched using a variety of parameters including client name, certificate number and/or product SGS designation and approval status SGS Belgium NV is a Notified Body with a notification scope described in the official European Nando database. The Notified Bodies must be designated by a national supervisory authority and notified by the EU Commission. This Dec 16, 2024 · In the EU, Article 117 of Regulation (EU) 2017/745 (MDR) requires a marketing authorization holder of a medicinal product that incorporates a nonreusable medical device (or integral drug-device combination product such as a prefilled syringe) to obtain an NBOp confirming the device part is compliant with the relevant general safety and performance requirements (GSPR)2 in Annex I of the EU MDR Verify the notified body confirmation letters issued according to European Regulation 2023/607 extending MDD certificate validity for SGS MDD clients. pfme zlivglu cmlcpdkm jelvo utlfwe fnyihb alwkb chbyulv phe xfugn