Notified body list pdf
Notified body list pdf. e. page 1 of 46 EUROPEAN COMMISSION ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL Consumer Goods Cosmetics and Medical Devices MEDDEV. 0 (09/18/2019) EMCD Page 4 of 30 European industry, European standardisation and Notified Bodies. 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. 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. 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. Norwida 1460-867 PoznańCountry : Poland Notified Body number : 2775 CE 2827 TÜV THÜRINGEN Polska Sp. Depending on legacy devices classification, MDR transition deadline is May 2026 for Class III custom-made implantable devices, December 2027 for Class III and Class IIb implantable devices (non-WET) and December 2028 for other Class IIb, Class IIa, Class Is and class Im devices. R. Box 1702027 KJELLERCountry : Norway Notified Body number : 0431 CE 0435 Kiwa ASPO BOX 141 - Økern Kabelgaten 20509 OSLOCountry : Norway Notified Body number : 0435 Notified Body is required. It is our goal to ensure that the information provided is both timely and accurate. A leading full scope Notified Body (2797). S. The 4 digit notified body number has been retained, i. DNV operates two Notified Bodies for PED and can assist you in demonstrating conformity with PED and applying the CE mark to your products. 1/Rec2 Stage 4. The summary of safety and clinical performance must include at least the following: Identification of the device and the manufacturer, including the UDI, Intended purpose of the device, target population, indications and contraindications, if any, • ZA. Caleruega, 10228033 MADRIDCountry : Spain Notified Body number : 0052 CE 0053 TÜV SÜD ATISAE, S. A. SGS Belgium NV is a Notified Body for your range of products and certification will be undertaken as Notified Body 1639. TÜV SÜD BABTs UK Approved Body Number 0168 has been retained. 2 Management of impartiality Requirements of article 27 of MID or article 23 of NAWID shall be considered, in particular: Section 3: “A conformity assessment body shall be a third-party body independent MID & NAWID Certificates Art. A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. A Notified Body (NB) is a conformity assessment body designated under the Medical Device Regulation (MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746) that assesses the conformity of medical devices for CE marking before they enter the European 1. This document lists notified bodies under Directive 2014/68/EU for pressure equipment. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation such as Pressure Equipment Directive (PED), when a third party is required. Żeliwna 3840-599 KatowiceCountry : Poland Notified Body number : 2827 I devices will require the approval of a Notified Body. O. VERENIGING BUREAU VERITAS is responsible for conformity PositionPaper-ExpiringCertificates-20201215. 1/Rec1 Stage 3 6 & 7/06/2000 Representative sample NB -MED/2. 7 Services supplied by an insurance agent to any person carrying on insurance business. 5KB: 488: Notice regarding Meeting for the registration of notified body through online portal: 2017-Apr-07: 542KB: 489: Public Notice regarding Price Control dated 06. de The Notified Body Opinion Maeve Lally, EMA Drug Device Guideline Drafting group, BWP Member Webinar on the implementation of Article 117 of the Medical Device Regulation 27 November 2020 An assessor’s view Intertek Medical Notified Body ABTorshamnsgatan 43, Box 1103SE-164 22 KistaCountry : Sweden Notified Body number : 2862 Eidgenössisches Institut für Metrologie METAS - Zertifizierungsstelle METAS-CertLindenweg 50CH-3003 Bern-WabernCountry : Switzerland Notified Body number : 1259 Communication with the notified body before an application is lodged Manufacturers should contact their notified body to clarify the language requirements for the technical documentation submission of the individual notified body as mentioned in the MDR, per Article 52 (12). This was in response to widespread concern that the performance of Notified Bodies in the medical device sector, and that of the Designating Authorities responsible for them, was variable and inconsistent. 3. Brexit. 7. EU regulators recognized a need to overhaul the regulation of medical devices and have stricter oversight of the Notified Bodies designated to regulate medical device 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 If the pressure equipment meets the requirements of PED, CE marking may be applied and the equipment may be traded freely across the European market. Box 1000FI-00581 HELSINKICountry : Finland Notified Body number : 0416 CE 0424 INSPECTA TARKASTUS OY(Sörnäistenkatu 2) P. A Guide to the In Vitro Diagnostic Directive 3 submit the summary to the Notified Body. For example, 35,000 IVDs will be covered by Notified Bodies for the first time. Feb 23, 2021 · Read the list of product categories covered by UK registered Approved Bodies (PDF, 525 KB, 56 pages) Conformity assessment body (CAB): An Approved Body, Notified Body, Recognised Third Party 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. 2018 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. EU Notified Bodies designated under the EU MDR (2017/745) Click the links below or view the entire list on the NANDO MDR database. This is a crucial process and should be carried out by Notified Bodies. Sections Authorized to act as a notified body under the European Regulation (EU) 2017/745 on medical devices and the European Regulation (EU) 2017/746 on in vitro the first list of notified bodies (if that is later) in NANDO: 5147-2024-INIT/EN/pdf also with a view to the verification by a notified body TÜV NORD CERT GmbH Langemarckstraße 20 45141 Essen Germany 0044 *MD 1300 - Monitoring devices - *MD 1301 - Monitoring devices of non-vital physiological parameters - *MD 1302 - Monitoring devices of vital physiological DEKRA Certification GmbH is a notified body and certification body for medical devices. In the UK a Notified Body is a body which has been appointed by the department for Business Energy and Industrial Strategy (BEIS), to carry out one or more of the conformity assessment procedures cited in a directive. Requirements and guidelines (updated 13th of November 2020) TÜV Rheinland InterCert Muszaki Felügyeleti és Tanúsító Korlátolt Felelosségu TársaságGizella út 51-57. The updated list of the notified bodies as well as their scope can be interrogated from the following database: Oct 20, 2023 · the details of the notified body which carried out the conformity assessment procedure (if applicable) the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance ; your name and signature ; the date the declaration was issued ; supplementary information (if applicable) Nemko as a Notified Body. Váci út 48/ a-b. Designated bodies verify medical devices’ compliance with legal requirements. All UK based EU Notified Bodies became UK Market Conformity Assessment Bodies on the 1st Jan 2021 for their current scope of accreditation allowing UKCA certification work to commence immediately. H-1132 BudapestCountry : Hungary Notified Body number : 1009 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. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State. [1] [2] [3] More generally, a notified body is an independent, accredited body which is entitled by an authorized accrediting body. ul. The need for joint assessments Following the discovery of the fraudulent use of non-medical grade silicone in. nrw. The list of notified bodies, user inspectorates and recognised third party organisations notified by the Member States is available in the NANDO 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. Both new regulations introduce new obligations for Notified Bodies and will require the assessment of more products than ever before. It provides the identification number, address, and responsibilities of two notified bodies: 1. For the complete list of requirements that must be met in order to be designation (notified) to the EU by NIS T, please refer to the Apr 26, 2017 · NIST Notified Body (NB) Assessment Checklist – Radio Equipment Directive (RED) November 15, 2015 (Version 1. 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. 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 Notified Bodies are responsible for assessing and (re-)certifying most MDs and IVDs, allowing products to be placed on the market. Help us keep this information up to date. Upon definition of standards and Jan 24, 2024 · For example, if a body is notified for machinery, it should not issue certificates (“voluntary” or other) for products that are not machinery (such as personal protective equipment). Apr 20, 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. 01. VINÇOTTE sa/nv is responsible for conformity assessment modules and articles related to pressure equipment under Annexes I, III of the Directive. Only the devices specifically listed in Annex II require a Notified Body, for example PSA is only cancer marker in List B. A director of a company or a body corporate The company or a body corporate located in the taxable territory. No. 2017 under Drugs and Cosmetic Act to regulate the manufacture, import, sale and distribution of the medical devices and said rules are list of notified bodies designated by the member states and the efta coun-tries (eea members) under the new approach directives (1) including their identification numbers as well as the tasks for which they have been notified. 2017: 2017-Apr-06: 578KB: 490 systemically absorbed by the body in order to achieve their intended purpose, the notified body must seek a scientific opinion from either an NCA or EMA (Regulation (EU) 2017/745 Article 52(11)) 5 . If errors are brought to our attention, we will try to correct them. 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. Annex II ofthe Directive contains an inclusive list products which require certification by athird party called Notified Body. Grant of Certificate of Registration for a Notified Body for audit of Class A and Class B Medical Devices: A notified body accredited by National Accreditation Body( designated by Central Government) may apply in MD 1 to CLA for grant of registration certificate in MD 2. Th l ip nc m all regulated requirements for the product in question acro ss the EU, • ZA. Notified bodies hold key responsibilities and are an indispensable part of the CE marking system. Find out more A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP). However the Commission accepts no responsibility or Zenona Praczyka Sp. 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. Services “A conformity assessment body shall be established under national law of a Member State and have legal personality. INSPECTA SERTIFIOINTI OYP. Refine list of bodies using search criteria below and click on body name to view details 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 is set out in Annex I to this Regulation. DGUV Test Prüf- und Zertifizierungsstelle Fachbereich Rohstoffe und chemische Industrie der Deutschen Gesetzlichen Unfallversicherung e. A designated body (Swiss term) is the same as a notified body (EU term). 3 December 2009 The CE marking regulation for IVD medical devices, commonly known as the EU IVDR, is soon going into effect on May 26 th, 2022. this list is established per directive and covers the bodies notified up to 30 september 2003 body corporate to the said company or the body corporate. P. These bodies carry out conformity assessment procedures for all devices classified outside the lowest risk classification. to the EU Radio Equipment Directive (RED) 2014/53/EU Notified Body Requirements . 38 of the MID 2014/32/EU and art. 33 of the NAWID 2014/31/EU require the information exchange of EC-type examination certificates, EC-design examination certificates and quality system approvals issued by notified bodies. ) and IVDR (Table 2. Via Quintiliano, 4320138 - MILANOCountry : Italy Notified Body number : 0051 CE 0066 ISTITUTO DI CERTIFICAZIONE EUROPEA PRODOTTI INDUSTRIALI S. Notified bodies are listed in the New Approach Notified and Designated Organisations (NANDO) Information System which is maintained by the Commission. Find out more An accredited ISO 13485 Certification Body. • For companion diagnostics, the notified body must seek a scientific opinion from either an NCA or IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S. Avenida de los Artesanos, 2028760 TRES CANTOSCountry : Spain Notified Body number : 0053 Sep 23, 2019 · standards in full), use of a Notified Body is voluntary. o. In most cases presented to us, absolutely nothing. In the role as Notified Body, the CAB does not test or certify the radio equipment. Annex III (Module B) – EU Type Examination . ) By September 2024, the Notified Body and the manufacturer must have signed a formal written agreement. As a Notified Body with the identification number 0124, DEKRA Certification GmbH accompanies conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing These devices are normally introduced into the human body via an orifice or applied to the skin. 78 (E) dated 31 01. In order to achieve compliance with PED 2014/68/EU, the pressure equipment conformity assessment must be certified by a Notified Body, which will partner with you to achieve accreditation and meet production deadlines and schedules. The cost depends on which certification procedure that applies to your product and the complexity of the Notified Body: BSI Guide to Notified Body : BSI: ISO 13485:2016: ISO 13485 Frequently Asked Questions : BSI: The differences and similarities between ISO 9001:2015 and ISO 13485:2016: BSI: ISO 13485 – The proposed changes and what they mean for you: BSI: Risk Management: Risk management for medical devices and the new BS EN ISO 14971: BSI CUALICONTROL- ACI, S. Using a Notified Body is an advantage for you as a manufacturer or importer, and for some services it is mandatory. 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. Email us with corrections or additions. Additionally, the EU member state accrediting the notified body will then inform the European Commission that the product complies with the essential requirements (or not). Class III, implantable class Jan 12, 2024 · As Notified Bodies are officially designated, we will add them here. I wanted to write this article because we are asked, from time to time, if we can offer a Notified Body certificate (more accurately called an EC type-examination certificate) for a machine. Lists of Notified Bodies can be searched on the NANDO web site. Find out more A leading full scope UK Approved Body (0086). Box 1000FIN-00581 HelsinkiCountry : Finland Notified Body number : 0424 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 Notified Bodies List Found 77 Results Select Country AE - UNITED ARAB EMIRATES BE - BELGIUM BR - BRAZIL CN - CHINA DE - GERMANY DK - DENMARK ES - SPAIN FR - FRANCE GB - UNITED KINGDOM HK - HONG KONG IT - ITALY JP - JAPAN KR - REPUBLIC OF KOREA MX - MEXICO MY - MALAYSIA NL - NETHERLANDS NO - NORWAY SA - SAUDI ARABIA SE - SWEDEN SG - SINGAPORE TH 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. V. 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 Article 35: Authorities responsible for notified 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. NB number Notified bodies Country; 0462 : OVE Österreichischer Verband für Elektrotechnik : Austria : 2670 : ETS Energie- und Telecom Service Gmbh Jun 4, 2018 · What is a Notified Body and what does it have to do with the Machinery Directive 2006/42/EC?. The assessments also take into account the horizontal Act on notified bodies, 278/2016 , and the national act on the industry. 1 A list of product characteristics as well as the clauses in the standard in which the assessment or test method is se t ou r fd . 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 The 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states have designated, until February 2008, more than 1800 notified bodies. (DGUV)Theodor-Heuss-Straße 16030853 LangenhagenCountry : Germany Notified Body number : 0418 Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) July 2021: MDCG 2021-16: 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) July 2021: MDCG 2021-15 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Medical Products and Innovation Medical Devices Below you can find hyperlinks to published fees on notified bodies websites for MDR (Table 1. Subject: List of Notified Bodies registered with CDSCO under MDR, 2017- regarding As you are aware that Medical Devices Rules, 2017, has already been published vide G. 04. Feb 5, 2024 · This guide lists notified bodies for medical devices in the EU, explain what types of medical devices require a notified body, and more 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. Before the expiry of the certificate’s period of validity, the manufacturer must submit a renewed application to the notified body to maintain the Medical Device Notified Body Recommendations List Below is a list of Recommendations of Notified Bodies Medical Devices (NB-MED) on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC : (updated 08/04/2009) Issue Date or status Recommendation Title NB-MED/2. 2. A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market. 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; Additional information on the designation process and other aspects related to notified bodies: Guidance documents and forms Notified Body - Medical Device CE Marking. ” 4. z o. Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices Heinrich-Böll-Ring 10 · 53119 Bonn · Germany · Tel. An insurance agent Any person carrying on insurance business, P a g e 4 Oct 17, 2022 · Toni has 10 years of experience working in a UKAS accredited laboratory within a variety of roles. 1 Rev. 2 The proc edures for conformity assessment, namely the tasks to be carried out by the ma nufacturer and the Apr 26, 2017 · to the EU Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Requirements . The details of all Notified Bodies and 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. 78 (E) dated 31. 1 A Notified Body (NB) is a third-party conformity assessment body notified to perform specific conformity assessment tasks as described in a directive. The only valid “voluntary certification” is in areas where legislation provides that a certificate is not mandatory, but still only duly notified bodies In July 2000, Member States and the European Commission agreed to set up the Notified Body Operations Group (NBOG). The European Commission services will undertake to maintain this Guide. See specific sectoral guidance notices for stakeholders 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. : +49 228 97794-0 · Fax: +49 228 97794-44 · zlg(at)zlg. S Conformity Assessment Bodies (CABs) for Compliance . H-1143 BudapestCountry : Hungary Notified Body number : 1008 CE 1009 MBVTI Műszaki Biztonsági Vizsgáló és Tanúsító Intézet Kft. 0) Checklist to Assess U. Version 3. 3EC International (Slovakia) – 2265 LIST OF BODIES NOTIFIED UNDER DIRECTIVE : 2013/53/EU Recreational craft and personal watercraft Name and address of the notified bodies Identification number Responsible for the following products Responsible for the following procedures or modules Annexes or articles of the directives 1 / 42 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 Jan 11, 2024 · About 10 years ago, the French PIP breast implant scandal rocked the Notified Body world and made European Competent Authorities (Ministries of Health) stand up and take notice. 2. 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 to carry out Notified Body activities under all applicable Conformity Assessment Modules. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required. Before it can issue a CE certificate, the notified body must seek a scientific opinion from EMA or a national competent authority on the compliance of the substance with the requirements laid down in Annex I to Directive 2001/83/EC. Sep 23, 2019 · 1 A Notified Body (NB) is a third-party conformity assessment body notified to perform specific conformity assessment tasks as described in a directive. Role of EMA. Nemko Group is appointed official Notified Body for products falling under the following European directives: Radio Equipment Directive (RED): 2014/53/EU; Electromagnetic Compatibility (EMC) Directive Feb 15, 2021 · The Notified body accredited under sub-rule (1) of Rule 13 shall be competent to carry out an audit of manufacturing sites of Class A and Class B medical devices to verify their conformance with the Quality Management System and other applicable standards as specified under these rules in respect of such medical devices as and when so advised by the State Licensing Authority. Via Paolo Belizzi, 29/3329122 - PIACENZA (PC)Country : Italy Notified Body number : 0066 JUSTERVESENET - NORWEGIAN METROLOGY SERVICEFetveien 99 P. 1. Classifications of Medical Devices Under MDR Class I medical devices will require involvement of a Notified Body if APAVEImmeuble Canopy - 6 Rue du Général AudranCS 60123 - 92 412 COURBEVOIE CedexCountry : France Notified Body number : 0060 CE 0062 BUREAU VERITAS SERVICES8 Cours du Triangle92800 PUTEAUX - LA DEFENSECountry : France Notified Body number : 0062 TURKISH STANDARDS INSTITUTION (TSE)Necatibey Cad. pdf Proposed solutions: • Options should be examined for allowing toleration of manufacturers whose Directives certificates expired prior to successful completion of MDR/IVDR certification for as long as there is evidence of an MDR/IVDR application successfully accepted by a notified body the notified body scope of designation but they are also used by the notified body to: 1) describe the individual qualification of the NBs staff members 2) describe the qualification required for assessing a device These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes 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. For external use MDF4206 Revision No 1 (October 2021) - Page 2 For external use Conformity assessment activities and their fees According to this, a notified body can be an accredited testing laboratory, an inspection body or a certification body. Mar 20, 2020 · Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU NOTICE - regarding testing of Notified Diagnostics kits for hepatiitis Kit at ILBS New Delhi: 2017-Apr-24: 37. Annex III (Part A - Module B) – EU Type Examination . 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. The Importance of a Notified Body. U. partner where the notified body is located. Jan 10, 2020 · The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. The list of references of European Approvals for Materials is published in the Official Journal of the European Union. 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 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. TEAM-NB DOCUMENTS Team-NB-IVDConfirmationLetterTemplate-V2-20240710 10/07/2024 The BEV is presently notified body for the directive 90/384/EEC (Non-automatic weighing instruments) and for the directive 2004/22/EC of the European parliament and the council of 31 March 2004 on measuring instruments. cxjos yegrd cznsci ztrent dohfd uojdu dwlswcy ngfxygx pqq rqlncdl