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 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.

(6) 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).

(7) 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.

(8) 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 outsourced production compared to in-house production. Accordingly, it is necessary to include in duly substantiated cases the most important subcontractors and suppliers in the conformity assessment procedures.

(9) Subcontractors or suppliers cannot fulfil in the manufacturers’ place crucial obligations of manufacturers, such as keeping available the full technical documentation, as this would void the concept of the manufacturer as responsible in accordance with Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC. Therefore, the notified bodies should be advised on what they need to verify in case of outsourcing.

(10) Though regarded as two independent exercises, it is necessary to strengthen the link between the quality system review and the review of the technical documentation on a sampling basis.

(11) In the absence of established practice for unannounced audits it is important to determine the practicalities for such audits, as well as to provide advice on the arrangements needed for facilitating these audits,

HAS ADOPTED THIS RECOMMENDATION:

1. PURPOSE

To facilitate the consistent application of the conformity assessment provisions contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC, the notified bodies should apply the provisions of this Recommendation when they perform product assessments, quality system assessments and unannounced audits.

By providing general guidelines for such assessments and unannounced audits, this Recommendation should facilitate the work of the notified bodies as well as the Member States’ evaluation thereof. This Recommendation does not create any new rights and obligations. The legal requirements applicable to all types of devices and conformity assessments are set out in the Union legislation on medical devices.

2. GENERAL GUIDELINES FOR AUDITS AND ASSESSMENTS

The notified bodies should apply the following:

(a) Where the manufacturer has applied for a design dossier examination or for a type examination (hereinafter jointly referred to as ‘product assessment’), notified bodies should verify the conformity of the device under all product related aspects referred to in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting any non-compliance of the device and should apply Annex I.

(b) Where the manufacturer has applied for an assessment of its quality system, notified bodies should verify the conformity of the quality system with the quality-system related requirements contained in Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC for detecting non-compliances of the quality system and should apply Annex II.

(c) To verify the day-to-day compliance with legal obligations, notified bodies should, in addition to the initial, surveillance or renewal audits, visit the manufacturer or, if this is likely to ensure more efficient control, one of its subcontractors in charge of processes which are essential for ensuring compliance with legal requirements (‘critical subcontractor’) or a supplier of crucial components or of the entire devices (both: ‘crucial supplier’) without prior notice (‘unannounced audits’) in accordance with Annex III.

3. FOLLOW-UP

Member States should draw this Recommendation to the attention of the notified bodies in the field of medical devices and should supervise the practice of notified bodies with respect to this Recommendation. They should evaluate the notified bodies’ readiness to apply this Recommendation and in particular to perform unannounced audits when deciding on designations of bodies and on renewal or withdrawal of designations.

4. ADDRESSEES

This Recommendation is addressed to the Member States.

Done at Brussels, 24 September 2013. For the Commission Neven MIMICA Member of the Commission

(1) OJ L 189, 20.7.1990, p. 17.

(2) OJ L 169, 12.7.1993, p. 1.

(3) OJ L 331, 7.12.1998, p. 1.

(4) OJ L 157, 9.6.2006, p. 24.

(5) OJ L 212, 9.8.2012, p. 3.

(6) OJ L 131, 16.5.2002, p. 17.