Notified body list. Below is an updated list of all the Notified Bodies currently designated under EU MDR: 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 national competent authority monitors and reassesses notified bodies periodically in order to ensure that they are still meeting their obligations. 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 notified body list for the Medical Device Regulation (MDR) has been updated, as TÜV SÜD, Denmark, becomes the latest notified body: Stage two audit is performed at the facility against ISO 13485 compliance. Search by country. The Commission shall assign an identification number to each notified body for which the notification becomes valid in accordance with Article 42(11). It shall assign a single identification number even when the body is notified under several Union acts. Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR Information about bodies including their contact and notification details can be found in section Notified bodies. The NANDO (English site) database includes all bodies registered for these guidelines. Search by country Search by legislation Free search Mutual recognition agreements EU-South Korea free trade agreement (FTA) Protocol on Ireland/Northern Ireland CETA - Protocol on Conformity Assessment Notifying authorities Accreditation bodies . thedens@ptb. Avenida de los Artesanos, 2028760 TRES CANTOSCountry : Spain Notified Body number : 0053 TÜV AUSTRIA SERVICES GMBHDeutschstraße 101230 WIENCountry : Austria Notified Body number : 0408 CE 0433 ÖSTERREICHISCHE VEREINIGUNG FÜR DAS GAS- UND WASSERFACHSchubertring, 141015 WienCountry : Austria Notified Body number : 0433 TÜV AUSTRIA SERVICES GMBHDeutschstraße 101230 WIENCountry : Austria Notified Body number : 0408 CE 0433 ÖSTERREICHISCHE VEREINIGUNG FÜR DAS GAS- UND WASSERFACHSchubertring, 141015 WienCountry : Austria Notified Body number : 0433 Jun 10, 2020 · Looking for a Notified Body in the United Kingdom? In this guide, we list some of the UK’s Notified Bodies covering medical devices, personal protective equipment, electronics, and more. Caleruega, 10228033 MADRIDCountry : Spain Notified Body number : 0052 CE 0053 TÜV SÜD ATISAE, S. EU Notified Bodies designated under the EU MDR (2017/745) The lists as well as the designated tasks for each notified body are subject to regular update: as the notification of notified bodies (and their withdrawal, suspension, reinstatement) is the responsibility of the notifying EU Member State (and not of the European Commission), the data in this Nando database is provided by the designating Oct 1, 2020 · For this assessment, the Notified Body must operate in a non-discriminatory, transparent, independent and impartial manner. The cost depends on which certification procedure that applies to your product and the complexity of the Mar 9, 2016 · These practices are misleading since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. CE 0060 . Free search. 0 Notified bodies directive 2014/31/EC Jul 10, 2019 · Article 43 Identification number and list of notified bodies 1. Notified Body in France. 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 Notified Bodies in the EEA Member States. nrw. Dec 14, 2020 · The European Commission published a list of recognized notified bodies that perform assessment tests on products like toys, electronics, medical devices, and more. P. Żeliwna 3840-599 KatowiceCountry : Poland Notified Body number : 2827 Notified Body: designated third party testing-, certification-, or inspection body. Access the NANDO-CPR database for a list of all official notified bodies. 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. Access the online tool for EC declaration of conformity for noise emissions by outdoor equipment. 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 List of accreditation body. Your Name (required) Your Email (required) Aug 10, 2021 · For this purpose, Notified Bodies must be involved with the exception of IVDs in Class A. 2018 Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 Team-NB is the European Association of Notified Bodies active in the Medical device sector. Feb 5, 2024 · Additionally, we provide a list of various notified bodies in the EU for medical devices and explain how you can search for a notified body in other EU member states. 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. A. Devices that successfully pass the conformity assessment procedure of a Notified Body receive a CE marking. For example, if a body is notified to issue certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal Suva CERTIFICATIONRösslimattstrasse 39, Postfach 43586002 LUZERNCountry : Switzerland Notified Body number : 1246 EU Notified Bodies List : Body type Name Country NB 1502 Hansa-Nord-Labor GmbH. Via Paolo Belizzi, 29/3329122 - PIACENZA (PC)Country : Italy Notified Body number : 0066 Oct 17, 2022 · Toni has 10 years of experience working in a UKAS accredited laboratory within a variety of roles. List of Notified bodies accredited for Medical Device CE The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. The NANDO database is very important for: companies, who can find in it the list of notified bodies which can assess the conformity of their products; Jan 24, 2024 · These notified bodies are organisations designated by EU countries to assess the conformity of certain products before they can be placed on the market. Wilmersdorf, 50 (PO Box 137, 7300 AC)7327 AC APELDOORNCountry : Netherlands Notified Body number : 0063 (ex-0620,0956) Notified bodies for ATEX. Notified Bodies and Certificates module. The list of notified bodies, user inspectorates and recognised third party organisations notified by the Member States is available in the NANDO database. What is a notified body? NBs assess the conformity of products to applicable requirements before manufacturers place them on the EU market. The Commission assigns a 4-digit code to each Notified Body, with the purpose of uniquely identifying each company that acts as a Notified Body. 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. Email us with corrections or additions. This page is for notified bodies (NBs). As you might have noticed based on the words in brackets, not all Notified Bodies are created equal, to say the least. 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. U. de; Ex-NBG Clarification Sheets noted by the ATEX Committee; What other Directives are relevant? This scope is determined based on the notified body’s competence and ability to perform services. LIST OF BODIES NOTIFIED UNDER DIRECTIVE 94/9/EC Equipment and protective systems intended for use in potentially explosive atmospheres Name and address of the notified bodies Identification number Responsible for the following products Responsible for the following procedures / modules Annexes / articles of the directives AIB-VINÇOTTE A leading full scope Notified Body (2797). The list of EU-notified bodies that we provide is retrieved from the notified bodies (NANDO) database. 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 NB number Notified bodies Country; 0462 : OVE Österreichischer Verband für Elektrotechnik : Austria : 2670 : ETS Energie- und Telecom Service Gmbh Suva CERTIFICATIONRösslimattstrasse 39, Postfach 43586002 LUZERNCountry : Switzerland Notified Body number : 1246 产品出口欧盟需要通过CE认证，而CE认证的发证机构就是我们通常所说的公告机构-Notified Body，简称NB机构。 每个欧盟认可的公告机构都一个四位数的编号，在欧盟NANDO数据库中可以找到所有公告机构的列表，可以详细查阅每个公告机构的信息，包括公告机构号 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. de; Technical Secretariat: hermann. Find out more A leading full scope UK Approved Body (0086). Information related to Notified Bodies. If they are successfully designated in […] Sep 10, 2024 · On paper, all Notified Bodies are the same: They all audit you based on the same standards (supposedly), their audits are all equally qualified (at least on paper), and their prices are transparent (kind of). These labs are affiliated with EU-notified bodies and are marked with an DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Rohstoffe und chemische Industrie der Deutschen Gesetzlichen Unfallversicherung e. 2017 under Drugs and Cosmetic Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are effective from 01. See specific sectoral guidance notices for stakeholders That is why they are referred to as notified bodies. Zenona Praczyka Sp. 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 Subject: List of Notified Bodies registered with CDSCO under MDR, 2017- regarding As you are aware that Medical Device Rules 2017 has already been published vide G. List of Notified bodies per Country. Prior to working at Test Labs, Toni worked in an ISO 15189 accredited clinical biochemistry department within the NHS; achieving her Bachelor of Science degree in Applied Biomedical Science at the University of Westminster and became a HCPC registered biomedical scientist, gaining knowledge and Information about bodies including their contact and notification details can be found in section Notified bodies. de IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S. Reach out in case you need support. Germany NB 1503 VHT Versuchsanstalt für Holz- und Trockenbau GmbH CUALICONTROL- ACI, S. Access the list of notified bodies by legislation and sector on the NANDO website. 112, 06100 BakanliklarAnkaraCountry : Turkey Notified Body number : 1783 CE 1784 Türkiye Çimento Sanayicileri Birliği Derneği Kalite ve Çevre Kurulu İktisadi İşletmesiAnkara Teknoloji Geliştirme Bölgesi, Cyberpark Dilek Binası 1605. 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 The U. Once designated, the notified body can only work within the scope determined by the designation. dinkler@vdtuev. EU AR, PRRC, Swiss AR. Norwida 1460-867 PoznańCountry : Poland Notified Body number : 2775 CE 2827 TÜV THÜRINGEN Polska Sp. Market surveillance Information about bodies including their contact and notification details can be found in section Notified bodies. Current lists of MDR- and IVDR-designated Notified Bodies. Market surveillance (ICSMS) Information and Communication System for Market Surveillance (ICSMS) is the comprehensive communication platform for market surveillance on non-food products and for mutual recognition for goods. Notified Bodies are government-appointed testing bodies that perform various tasks to verify the conformity of medical devices prior to market approval. Notified Bodies may also offer separate testing services for standards that support the manufacturer’s CE marking. z o. Find out how notified bodies are designated and cooperate under the EU Construction Products Regulation (CPR). Help us keep this information up to date. As Notified Bodies are officially designated, we will add them here. 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. Methodology. (DGUV)Theodor-Heuss-Straße 16030853 LangenhagenCountry : Germany Notified Body number : 0418 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 Kiwa Nederland B. You can choose a notified body from the list on the NANDO website Home Notified Bodies . Jan 12, 2024 · Shown below is a list of European Notified Bodies that have been designated under the EU MDR or IVDR. Disclaimer: We are not affiliated with any of the companies listed in this guide Dec 16, 2022 · Notified Bodies and Certificates. The European Commission keeps a list of Notified Bodies by EU countries on the NANDO (New Approach Notified and Designated Organizations) website. The usefulness of NANDO. R. Find out what notified bodies are, what they do, and how they are controlled in the EU. Each company profile also covers services, product categories, and location. S. Before the expiry of the certificate’s period of validity, the manufacturer must submit a renewed application to the notified body to maintain the Vertigo Inspection (ROI) Ltd t/a Irish Engineering ServicesRSA House, Dundrum Town Centre, Sandyford Road, Dublin 16 D16 FC92DublinCountry : Ireland Notified Body number : 2820 CE 2831 BRE Global Assurance (Ireland) LtdDCU Alpha, Old Finglas Road, GlasnevinDublin 11 D11 KXN4Country : Ireland Notified Body number : 2831. Find out more A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP). No. Find information about notified bodies that carry out conformity assessment according to EU directives. Brexit. Notified bodies are also conducting unannounced audits to confirm the quality system compliance. APAVEImmeuble Canopy - 6 Rue du Général AudranCS 60123 - 92 412 COURBEVOIE CedexCountry The list of references of European Approvals for Materials is published in the Official Journal of the European Union. o. For example, if a body is notified to issue certificates for machinery, it should not issue certificates (voluntary or other) for non-machinery products (such as personal Article 35: Authorities responsible for notified bodies. Notified Bodies under Regulations (EU) 2017/745 and (EU) 2017/746 . 01. Notified bodies (NANDO) Notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. The following WELMEC guides should be considered: - WELMEC guide 8. It explains our role for NBs and how a conformity assessment body can apply to become a NB. List of notified bodies under Directive 2014/34/EU (NANDO Information System) European Coordination of ATEX Notified Bodies Group (ExNBG) Chairperson: martin. These practices are misleading since only notified bodies may issue certificates of compliance for harmonised products and only in the area for which they are notified. The Commission publishes a list of designated notified bodies in the NANDO information system. The following offers an overview of all current Notified Bodies listed in Notified Body List; Home » Country. Search by legislation. 1. 1: Designation, re-assessment and notification of conformity assessment bodies and notified bodies: June 2024: MDCG 2021-23 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. Audit duration and number of auditors are determined by the notified body based on device class and risk involved. Via Quintiliano, 4320138 - MILANOCountry : Italy Notified Body number : 0051 CE 0066 ISTITUTO DI CERTIFICAZIONE EUROPEA PRODOTTI INDUSTRIALI S. V. 78 (E) dated 31 01. Find out more An accredited ISO 13485 Certification Body. : +49 228 97794-0 · Fax: +49 228 97794-44 · zlg(at)zlg. ul. The list of labs below includes labs that are formally authorized to certify products covered by regulated directives for CE Mark requirements. Feb 23, 2021 · Conformity assessment body (CAB): An Approved Body, Notified Body, Recognised Third Party Organisation, User Inspectorate or Technical Assessment Body formally recognised as able to assess Questions and answers: Requirements relating to notified bodies: October 2022: MDCG 2022-13 Rev. 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. Notified body designation and oversight. Jun 27, 2023 · Although it is the notified body that issues the certificate, the manufacturer is fully responsible for meeting the requirements for CE marking and thus also for maintaining the certificate. The Enterprise and Industry Directorate-General at the European Commission provides lists of the Notified Bodies in the NANDO (New Approach Notified and Designated Organisations) information system: TURKISH STANDARDS INSTITUTION (TSE)Necatibey Cad. kxygftxhdtqcmyfecfuhgdededtjnvqxwwqusaceedeciprkvxjmk