Recommendation 2013/473 - 2013/473/EU: Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices - Main contents

EN

Official Journal of the European Union

L 253/27

The proper functioning of notified bodies is crucial for ensuring a high level of health and safety protection, the free movement of medical devices in the internal market, and citizens’ confidence in the regulatory system.

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 (1), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (2), and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (3), contain certain provisions with regard to the audits, assessments and unannounced audits performed by notified bodies in the field of medical devices.

The interpretation of those provisions and the behaviour of notified bodies designated in the field of medical devices differ. Therefore this Recommendation should set benchmarks for assessments and unannounced audits by notified bodies and respond to the most frequent shortcomings of the current practices.

The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requirements by the manufacturer.

Subject to the respective conformity assessment procedure, notified bodies perform product assessments or quality system assessments. Accordingly, it is important to differentiate between these two types of assessments. To verify the continuous compliance with legal obligations, notified bodies should perform unannounced audits in addition to product assessments and quality system assessments.

In order to satisfy the legal requirements laid down in Directive 90/385/EEC, in Directive 93/42/EEC and in Directive 98/79/EC, notified bodies should verify, where relevant, the fulfilment of the essential safety and health requirements contained in Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (4), of the requirements contained in Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (5) and of the common technical specifications for in vitro diagnostic medical devices laid down in Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in vitro diagnostic medical devices (6).

In order to avoid omissions and mistakes in the verification by the notified bodies of the important aspects of clinical evaluation or, in the case of in vitro diagnostic medical devices, of performance evaluation, and with regard to the post-market clinical follow-up, or, in the case of in vitro diagnostic medical devices, to post-market follow up, it is important to provide specific advice with regard to the control of those requirements.

To facilitate the verification by the notified bodies of the technical documentation, the manufacturer’s device identification system and the declaration of conformity, it is important to provide specific advice with regard to the control of those requirements. Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC do not provide any exceptions for...