A notified body shall notify the competent authority of certificates it has granted for class D devices, with the exception of applications to supplement or renew existing certificates. Such notification shall take place through the electronic system referred to in Article 52 and shall include the instructions for use referred to in Section 20.4 of Annex I, the summary of safety and performance referred to in Article 29, the assessment report by the notified body, and, where applicable, the laboratory tests and the scientific opinion by the EU reference laboratory pursuant to the second subparagraph of Article 48(3), and where applicable the views expressed in accordance with Article 48(4) by the experts referred to in Article 106 of Regulation (EU) 2017/745. In the case of divergent views between the notified body and the experts, a full justification shall also be included.
2.
A competent authority and, where applicable, the Commission may, based on reasonable concerns apply further procedures in accordance with Article 40, 41, 42, 43 or 89 and, where deemed necessary, take appropriate measures in accordance with to Articles 90 and 92.
3.
The MDCG and, where applicable, the Commission, may, based on reasonable concerns, request scientific advice from the expert panels in relation to the safety and performance of any device.
Official catalogue · non-binding
Related guidance (9)
Current English catalogue entries that refer to Article 50. Guidance is non-binding and kept separate from the regulation text.
Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024⌄
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MDCG 2022-12Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)July 2022⌄
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MDCG 2020-16 rev.4Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746March 2025⌄
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MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexPreliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
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MDCG 2023-2 MDCG 2023-2 MDR form MDCG 2023-2 IVDR formList of Standard FeesJanuary 2023⌄
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MDCG 2019-6 rev.5Questions and answers: Requirements relating to notified bodiesFebruary 2025⌄
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MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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MDCG 2022-14Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDsAugust 2022⌄
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Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products
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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
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Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
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Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC
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Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products
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Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
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Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
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Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use
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Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components
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Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells
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Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery
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Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes
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Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare
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Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights
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Directive 2014/30/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to electromagnetic compatibility
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Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
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Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment
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Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
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Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
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Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
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Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products
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Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
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Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation
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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation)
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
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