List of eu notified bodies

List of eu notified bodies. Lists of Notified Bodies are on the NANDO website (New Approach Notified and Designated Organisations). Notified bodies (NANDO) As required by regulations, CE marking certificates are mandatory to put medical devices on the European market. Dec 14, 2020 · The European Commission provides a regularly-updated list of notified bodies in the NANDO (New Approach Notified and Designated Organisations) System, which allows users to search Notified Bodies based on their country, their 4-digit code the directives and regulations for which they are designated, and other categories. de Dec 16, 2022 · Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices introduce an EU device identification… Notified Bodies and Certificates Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Feb 23, 2021 · EU CAB: A conformity assessment body recognised by the EU as able to carry out conformity assessment activities for the EU market. List of notified bodies under Directive 2014/34/EU (NANDO Information System) European Coordination of ATEX Notified Bodies Group (ExNBG) Chairperson: martin. The Commission publishes the list of notified bodies according to Article 43 of Regulation (EU) 2017/745 and Article 39 of Regulation (EU) 2017/746, including the conformity assessment activities and the types of devices they are authorised to assess. Mar 30, 2022 · clearer roles for Notified Bodies and Technical Assessment Bodies; CE marking step-by-step. For example, 35,000 IVDs will be covered by Notified Bodies for the first time. A lot rides on selecting the right Notified Body, so it’s imperative that you find the organization that best fits your company’s needs. uk web site. Article 36: Changes to Notifications. Therefore, no, an EU Notified Body may not issue UKCA Marking. Aug 10, 2021 · On the NANDO website (“New Approach Notified and Designated Organisations”), the EU Commission maintains a list of all IVDR- and MDR-certified Notified Bodies. Notified bodies (NANDO) Oct 1, 2020 · The European Commission keeps a list of Notified Bodies by EU countries on the NANDO (New Approach Notified and Designated Organizations) website. Notified bodies (NANDO) Article 35: Authorities responsible for notified bodies. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). Aug 14, 2024 · IVD NB’s play a major role in assisting manufacturers to place only safe and efficient IVD medical devices on the EU market. Information related to Notified Bodies. There is a list on the . Brexit. Where can I find a list of designated EU MDR Notified Bodies? A list of EU MDR certified Notified Bodies can be found in a number of different places. Nov 8, 2021 · What do notified bodies do? Notified bodies are the sole issuers of EC-type Examination Certificates, which confirm devices are safe for public sale in the EU market. Article 39 The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. It explains our role for NBs and how a conformity assessment body can apply to become a NB. . Stage two audit is performed at the facility against ISO 13485 compliance. EU AR, PRRC, Swiss AR. eu domain. g. The legal provisions governing the activities of notified bodies under Regulation (EU) 2016/425 and in particular the articles on coordination (Art. Notified Bodies are free to offer their conformity assessment services for which they are notified to any manufacturer established either inside the EU or in All official European Union website addresses are in the europa. The current list of designated Notified Bodies is included below. A list of all official notified bodies under the construction products regulation is available in the NANDO-CPR database. The lists include the identification number of each notified body as well as the tasks for which it has been notified, and are subject to regular update. It has been listed in the NANDO database and assigned a Notified Body number of 0537. Notified Body Status. As Notified Bodies are officially designated, we will add them here. Nov 1, 2022 · The EU Commission published updated statistics related to MDR/IVDR certification, available: HERE Forty-seven of the 51 Notified Bodies contributed responses, including 37 designated to the MDR/IVDR. Reach out in case you need support. Notified Bodies Designated to MDR 2017/745. If they are successfully designated in […] Jun 10, 2020 · More specifically, Element provides Notified Body services for four EU Directives, UKAS, A2LA, and RvA accreditations, as well as certification for the most common quality management systems such as ISO 9001, ISO 14001, ISO 27001, ISO 44001, ISO 45001 and ISO 5000. gov. The MHRA publishes the full list of UK Approved Bodies Mar 10, 2021 · Dear Dimitris, thanks for your comment. Click here to Check list of currently designated MDR Notified Bodies In the meantime you can: Download the free MDR Gap Analysis Tools Check latest MDCG Check guidance documents from EU and Notified Bodies Review the list of Meddev Guidances Reach out for support Learn more about UDI/EUDAMED Check the List of Harmonized Standards Jul 1, 2023 · From 1 January 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognised notified body to undertake any mandatory The U. Notified bodies (NANDO) Every organisation which had Notified Body status in the UK in 2020 was offered the chance to become an Approved Body, and most of them have done so. The list of notified bodies, user inspectorates and recognised third party organisations notified by the Member States is available in the NANDO database. List of notified bodies under Directive 2014/34/EU (NANDO information system) European coordination of ATEX notified bodies group 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 The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. Notified bodies (NANDO) Jul 3, 2024 · However, if you opt to use the services of a notified body, or if the EU specifications applicable to your product require the independent assessment by a notified body, then you must pay the notified body for the service they provide. BSI (Netherlands) BSI (UK) CE Certiso (Hungary) DARE!! Services (Netherlands) DEKRA Certification (Germany) DEKRA Certification Sep 12, 2022 · [article originally published on June 10, 2021] Comparison of Notified Body (NB) fees for the Medical Devices Regulation. Manufacturers who plan to CE-mark their products or who are looking for a 'to-do list' can consult the CE marking step-by-step. The information can be filtered by legislation to identify: List of notified bodies under Regulation (EU) 2017/745 on medical devices; List of notified bodies under Regulation (EU) 2017/746 on in vitro diagnostic medical devices Lists of Notified Bodies can be searched on the NANDO web site. See all EU institutions and bodies. Notified bodies (NANDO) New Approach Notified and Designated Organisations (NANDO). Importers of products/ingredients that require organic certification should ensure that the certifying body of the UK product has been recognised by the EU Commission. A Notified Body is an independent organization designated by an EU Member State to make sure that the Medical Device Requirements (MDR) and In Vitro Diagnostic Requirements (IVDR) are being followed for as long as the product remains on the market. That said, many EU Notified Bodies also offer, or intend to offer, UKCA marking certification through a UK subsidiary/sister company. Notified bodies (NANDO) Jul 14, 2020 · To date, 44 MDR and 11 IVDR applications have been received, recently reported by the EU Commission. That is why they are referred to as notified bodies. Notified bodies conduct in-depth assessments of the design, manufacturing, and functionality of a medical device through a variety of tasks, such as: Examine technical design Feb 1, 2024 · Notified Bodies have had to go through a new designation and notification process under the new European Union Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (IVDR). Notified Bodies are also designated by European Economic Area (EEA) countries, as well as by other countries (e. It shall assign a single identification number even when the body is notified under several Union acts. List of bodies notified under Directive 2014/33/EU (NANDO information The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. Any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under this Regulation shall appoint an authority (‘authority responsible for notified bodies’), which may consist of separate constituent entities under The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. Conformity Assessment Bodies Seeking Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Status and the UK Notified Bodies (UK NoBos) are UK bodies authorised to assess the compatibility of works or equipment with Technical Specifications for Interoperability (TSI) as part of the system to effectively and safely allow the interoperability of railway services within the European Union. Notified bodies hold key responsibilities and are an indispensable part of the CE marking system. Article 37: Challenge to the Competence of Notified Bodies. The Commission publishes a list of designated notified bodies in the NANDO information system. Who appoints a Notified Body? Notified Bodies are designated by the Competent Authorities of each EU and EEA Member State or any other state which has concluded a Mutual Recognition Agreement and Protocols to the Europe Agreements on Conformity Assessment and Acceptance of Industrial Products (PECAs) 4) and are Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. Classifications of Medical Devices Under MDR Class I medical devices will require involvement of a Notified Body if You can search the list of notified bodies on the European Commission’s NANDO (New Approach Notified and Designated Organisations) informational website. 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 38: Coordination of Notified Bodies. dinkler@vdtuev. Minimum time to complete a procedure Notified bodies were asked to provide the minimum time needed to finalise a full procedure for conformity assessment in relation to medical devices and in vitro diagnostic medical Notified bodies for lifts. Refine list of bodies using search criteria below (by entering appropriate keywords) and click on body name to view details. Notified bodies are designated by EU countries. : +49 228 97794-0 · Fax: +49 228 97794-44 · zlg(at)zlg. Email us with corrections or additions. Notified Body: designated third party testing-, certification-, or inspection body. The usefulness of NANDO The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. It may be accessed here: Oct 18, 2022 · The Approved Body must be a legal entity established in the UK and be designated by the MHRA. Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the Application form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices Regulation (IVDR) Nov 2017: NBOG F 2017-3: Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/745 (MDR) Nov 2017: NBOG F 2017-4 The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. NIST serves as the Notifying Authority4 and is responsible for designating (notifying) to the European Commission qualified U. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State. Jan 12, 2024 · Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. Such bodies may be located outside of the EU, for example, if List of Notified bodies per Country. Switzerland or Turkey) with specific agreements with the EU. A notified body is an organisation designated by an EU country to assess the conformity of certain products, for example, lifts and lift components, before being placed on the market. For selected proposals from notified bodies, the expert panels will advise: either on a possible orphan status of a device; or on the data required for the clinical evaluation during an ongoing conformity assessment. Aug 28, 2019 · The EU Medical Devices Regulation (MDR) was published on May 5, 2017. 36) and on the Oct 4, 2022 · A list of accredited Notified Bodies is available in the EU NANDO database, which can be searched and filtered by country, specific legislation, and other technical competencies. The European Commission ensures cooperation between notified bodies. Intertek has five European Union-based Notified Bodies located across Germany, Sweden, France, Spain and the United Kingdom. Notified bodies (NANDO) Team-NB is the European Association of Notified Bodies active in the Medical device sector. The following WELMEC guides should be considered: - WELMEC guide 8. Sep 23, 2019 · with the European Union (EU)2 and the European Economic Area (EEA) European Free Trade Association (EFTA) States3. GMED, as a notified body, identification number CE 0459, supports you through the certification process, sharing with you its expertise and know-how in the medical device industry. The Commission has published its Blue Guide which provides an overview of the product regulatory system within the European Union. The Commission strives to maintain an up-to-date list of bodies notified by EU countries and make the necessary information available to all interested parties. The NANDO (English site) database includes all bodies registered for these guidelines. The UK is now free to appoint bodies from outside its own territory if it wishes to, and so the list includes bodies from the USA, New Zealand and elswhere. 1. Your Name (required) Notified body designation and oversight. Search by legislation. The notified body will also need to assess whether conformity with all relevant Annex I General Safety and Performance Requirements has been demonstrated through clinical evidence. The list of references of European Approvals for Materials is published in the Official Journal of the European Union. Notified bodies are also conducting unannounced audits to confirm the quality system compliance. The practical enforcement of the Regulation EU 2016/425 and the application of European Standards by notified bodies require an exchange of experience between notified bodies. production. Both new regulations introduce new obligations for Notified Bodies and will require the assessment of more products than ever before. 2. English Home Notified Bodies Bodies. The NANDO database provides information on notified bodies responsible for assessing the conformity of goods (or, in the case of construction products, for the “assessment and verification of constancy of performance”) which are placed on the market in the EU. The information included in the list comes from the National Accreditation Bodies (NAB) who have notified the European Commission further to Commission's request in view of providing a publicly available informative list of the EU Conformity Assessment Bodies that have been accredited in accordance with Regulation (EU) 910/2014 (eIDAS) as competent to Jun 27, 2023 · The Danish Medicines Agency ensures that its control is updated in line with developments in the medical devices area in the EU through participation in the EU authorities’ working group in the field of notified bodies under the medical devices legislation. Information about the notified body is stored in an online database and includes a description of the particular scope of designation to assist medical device manufacturers when choosing a notified Konformitätsbewertungsstelle des Regierungspräsidiums Tübingen, Abteilung 10, Eich- und Beschusswesen Baden-Württemberg Bodies seeking accreditation for appointment as a UK Notified Body for the Northern Ireland market also need to be aware of EA-2/17 M: 2020 EA Document on Accreditation for Notification Purposes, a mandatory document identifying accreditation requirements for notified bodies undertaking conformity assessment activities for placing goods on the These bodies have been recognised by the Member States of the European Union and have subsequently been notified to the European Commission and the other Member States. nrw. Their references are published in the Official Journal of the European Union (OJEU). List of Notified Bodies by ZLG The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. The ZLG publishes the Notified Bodies on their website according to the EU regulations (MDR and IVDR). The notification is withdrawn, if the notified body does not fulfil the requirements or its duties, respectively, anymore. List of Notified bodies accredited for Medical Device CE Jan 24, 2024 · Only notified bodies under EU law can issue certificates of compliance for harmonised products and only in the area for which they are notified. Ask about EU 2021/2226 e-IFU compliant solution. This database includes all information about NB: the regulations and directives under which they can operate, the activities for which they are notified, and the devices covered by the NB Harmonized standards and normative documents, the list of which has been published in the Official Journal of the European Union, are necessary for the implementation of conformity assessment in the frame of the MID and NAWID. What is a notified body? NBs assess the conformity of products to applicable requirements before manufacturers place them on the EU market. S. As a result, there are currently only 38 Notified Bodies designated under EU MDR . Article 34: Operational Obligations of Notified Bodies. May 11, 2024 · Eurofins Electrical & Electronics (E&E) and Industrial global network of laboratories operate as European Notified Body certification bodies (CB) for CE Marking in accordance CE Marking Directives including; RED, ATEX, Medical Devices, IVDD, EMC, Low Voltage, Machinery, OND, PPE, MED, TPED and more. Notified bodies (NANDO) Oct 17, 2022 · Within the European Union (EU), notified bodies assessing against the EU 2017/745 MDR and 2017/746 IVDR are designated by European Economic Area (EEA) countries, as well as by other countries with specific agreements with the EU e. The full list of notified bodies based in Ireland and the associated Directives/Regulations may be found on the European Commission website. For the other countries of the European Union, this list is less prone to changes Article 33: Subsidiaries of Notified Bodies and Subcontracting. Apr 20, 2016 · Their references are published in the Official Journal of the European Union (OJEU). Current lists of MDR- and IVDR-designated Notified Bodies. 0 Notified bodies directive 2014/31/EC Feb 24, 2018 · Notified bodies for ATEX. Search by country. Below is an updated list of all the Notified Bodies currently designated under EU MDR: The notified body list for the Medical Device Regulation (MDR) has been updated, as TÜV SÜD, Denmark, becomes the latest 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. The European Commission publishes a list of such notified bodies. Consolidated lists of references of harmonised standards on equipment for explosive atmospheres (ATEX) Notified bodies for ATEX. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical devices. This brings the total number of Notified Bodies… For information the commission publishes a list of notified bodies in the Official Journal of the European Union. This list will be continuously updated as more Notified Bodies are added May 12, 2021 · The low number of Notified Bodies likely to be designated by next year will likely lead to increasing discussion about the appropriateness of postponing the IVDR Date of Application. They are controlling the manufacturers by conducting conformity assessment activities and granting CE certificates to IVD medical devices in accordance with EU IVDR 2017/746, Article 32. Notified bodies will submit their advice request in cooperation with the orphan device manufacturer. Notified bodies (NANDO) CERTIF 2012-06 REV1 – Notified Bodies - The use of the notified bodies number for activities not required by EU legislation (14 kB) 2011. The cost depends on which certification procedure that applies to your product and the complexity of the Notified Bodies are supervised by the Competent Authority of a particular EU Member State. Help us keep this information up to date. Notified bodies (NANDO) Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices Heinrich-Böll-Ring 10 · 53119 Bonn · Germany · Tel. The guide is available in all EU languages. The list of Notified Bodies, their scope of notification, and the list of Competent Authorities can be found on the NANDO website (New Approach Notified and Designated Organisations). We have the product expertise and full capability to test to a variety of directives, including: ATEX Directive (94/9/EC) Construction Products Regulation (CPR) EMC Directive (2004/108/EC) Notified bodies are organizations designated by EU member states to assess the conformity of certain products to meet the requirements of the European Union's directives and regulations before they can be sold within the EU. A current overview of all Notified Bodies in the NANDO database for IVDR certification can be found here. Audit duration and number of auditors are determined by the notified body based on device class and risk involved. The following offers an overview of all current Notified Bodies listed in the online database which are already MDR certified. Notified bodies are the only recognised third party carrying out the assessment of performance of construction products. List of notified bodies under Directive 2014/34/EU (NANDO Information System) European Coordination of ATEX Notified Bodies Group Jan 10, 2020 · List Of Notified Bodies Each notified body duly designated under the MDR or IVDR has its identification number assigned by the regulating authority. Article 35: Identification Numbers and Lists of Notified Bodies. These essential requirements are publicised in European directives or regulations. The list is updated regularly and can be obtained from the agencies of the commission directly. Notified bodies (NANDO) Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated, withdrawn or refused and other restrictions imposed on these certificates. The list of labs below includes labs that are formally authorized to certify products covered by regulated directives for CE Mark requirements. Notified Bodies may also offer separate testing services for standards that support the manufacturer’s CE marking. Eurofins Expert Services Oy of Finland is the latest European Notified Body designated under the Medical Devices Regulation (EU) 2017/745 (MDR), before the Date of Application (DOA) on May 26, 2021. The CE marking regulation for IVD medical devices, commonly known as the EU IVDR, is soon going into effect on May 26 th, 2022. EU Notified Bodies designated under the EU MDR (2017/745) Click the links below or view the The "Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG)" is responsible for designation and monitoring of the Notified bodies in Germany. thedens@ptb. The members are Notified Bodies under any or all of the three medical device directives: 90/385/EEC; 93/42/EEC; 98/79/EC. The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. Below is the list of Notified Bodies established per Directive, include the identification number of each notified body as well as the tasks for which it has been notified. A list of active Notified Bodies recognised under the new MDR can be found on the European Commission New Approach Notified and Designated Organisations (NANDO) database. de; Technical Secretariat: hermann. I devices will require the approval of a Notified Body. , Switzerland or Turkey. Here are examples of notified bodies that are commonly recognized for their roles in various sectors such as medical Apr 26, 2017 · The NIST Tel MRA Program Office maintains a list of these ABs who have successfully demonstrated compliance with all Accreditation Body qualifications included in Section 10 of the NIST Requirements & Application for U. This page is for notified bodies (NBs). The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. This list will be updated on an ongoing basis as more Notified Bodies Notified bodies for PPE List of bodies notified under Regulation (EU) 2016/425 on personal protective equipment (NANDO information system) European coordination of notified bodies - Horizontal Committee of Notified Bodies (HCNB) for PPE Technical secretariat: Abertech, email: info abertech [dot] it (info[at]abertech[dot]it) The new system includes all information flows between notifying authorities, designating authorities, accreditation bodies, notified bodies, market surveillance authorities, mutual recognition authorities, the Commission and, in the future, economic operators like manufacturers and importers. For some countries, including Italy, the list of notified bodies is constantly evolving because of Italy internal rules. Information about bodies including their contact and notification details can be found in section Notified bodies . These labs are affiliated with EU-notified bodies and are marked with an Unregulated certificates, which are often called ‘voluntary certificates’ besides other names, are often issued for some products covered by EU harmonisation legislation by certification bodies not acting in their capacity as notified bodies under EU law. Unfortunately some certification bodies issue certificates in areas beyond their competence, and call them ”voluntary certificates”. CABs seeking Notified Body status and for monitoring on-going compliance of these Notified Bodies. May 13, 2013 · The list below is the list of the NANDO Website dated 18 December 2014 and is given for information only and is valid on the date indicated. Notified bodies (NANDO) Jul 10, 2019 · Article 43 Identification number and list of notified bodies 1. Notified Bodies in Germany. UK Notified Bodies may be appointed by ministers of HM Feb 20, 2020 · The European Commission's NANDO website also provides a list of designated EU Notified Bodies as well as a list of Irish-based Notified Bodies. CERTIF 2011-01 - 2010 NMSPs submitted under article 18(5) of the Regulation 765/2008EC - Evaluation of the current implementation state in MS (441 kB) Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 . These practices are misleading since only notified bodies may issue certificates of European Commission’s Notified Body NANDO site; See Notified Bodies by legislation (by location) To view (a) the specific legislation and (b) types of conformity assessment services for which the Notified Body has been found competent, select the Notified Body’s link and view the full PDF document(s) posted at the bottom of the page. See specific sectoral guidance notices for stakeholders Notified Bodies are responsible for assessing and (re-)certifying most MDs and IVDs, allowing products to be placed on the market. de; Ex-NBG Clarification Sheets (6 MB) noted by the ATEX Committee 4 3. Free search. oreayqz pckh xti rmaok cqj mijb vwiz fiekwnmi arbat gcklf