Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary for specific tasks connected with conformity assessment, it shall verify that the subcontractor or the subsidiary meets the applicable requirements set out in Annex VII and shall inform the authority responsible for notified bodies accordingly.
2.
Notified bodies shall take full responsibility for the tasks performed on their behalf by subcontractors or subsidiaries.
3.
Notified bodies shall make publicly available a list of their subsidiaries.
4.
Conformity assessment activities may be subcontracted or carried out by a subsidiary provided that the legal or natural person that applied for conformity assessment has been informed accordingly.
5.
Notified bodies shall keep at the disposal of the authority responsible for notified bodies all relevant documents concerning the verification of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
Official catalogue · non-binding
Related guidance (6)
Current English catalogue entries that refer to Article 33. Guidance is non-binding and kept separate from the regulation text.
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⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
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⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
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⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2023-3 rev.2Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746January 2025⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
MDCG 2018-7Provisional considerations regarding language issues associated with the UDI databaseOctober 2018⌄
Unverified automated extraction preview. This text has not yet been checked against the official source and may contain omissions, ordering errors, table errors, missing images, or formatting errors. Consult the official source before relying on it.
Unofficial, non-binding reproduction. This reproduction is provided for convenience and does not create legal obligations. Consult the linked official source; the official source controls.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
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)
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Select the citation to open the authentic EUR-Lex version.
Official EU legal act
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices
Select the citation to open the authentic EUR-Lex version.