关于医疗器械领域公告机构审核和评估的建议2013_473_EU

RECOMMENDATIONS COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (Text with EEA relevance) (2013/473/EU) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof, Whereas: (1) 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. (2) 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. (3) 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. (4) The Recommendation aims at ensuring that the notified body carries out a proper verification of the fulfilment of the legal requirements by the manufacturer. (5) Subject to the respective conformity assessment procedure, notified bodies perform product assessments or quality system assessments. Accordingly, it is important to dif...