New regulation for notified bodies raises the bar for medical device CE mark

24 September 2013

New regulation has been published by the European Commission on 24 September 2013

New regulation for notified bodies raises the bar for medical device CE mark

Stricter controls for device safety in Europe

The European Commission has recognized the need to re-establish patient confidence in the medical devices sector, which had been lost to a significant degree as a result of the breast implant scandal and other events. The new regulation published on 27 September 2013 are to serve for the improvement of the safety of medical devices. As these regulations are immediately implemented, it is expected that the new measures will have direct repercussions on the relations between the notified bodies and the manufacturers of medical devices.

To read the new documents published by the European Commission on 24 September 2013, click below

More control on notified bodies

The new regulation has the purpose to enhance the supervision of the Accreditation bodies responsible for designation the notified bodies: therefore, stricter controls are to be applied by the controllers.

What activities of the notified bodies will be more strictly scrutinized? The central points of the controls will focus on the examination standards for the different notified bodies and the manner in which the CE mark conformity assessment procedures are conducted.

Why is this necessary? The expected goal is to improve supervision of the manufactures and better application of safety standards in the examination and monitoring of medical devices. In addition, these measures will create transparency and ensure EU-wide uniform implementation.

Content of regulation n. 920/2013

The new regulation defines the criteria to be met by the notified bodies responsible for supervising the manufacturer of medical devices. In summary, the more stringent requirements proposed are as follows:

  • A Member State shall not appoint a notified body until after a “joint assessment” by experts from the Commission and the Member States. Hence, the designating authority of the Member State where the conformity assessment body is established shall involve representatives of the designating authorities from two other Member States as well as a Commission representative in the procedure for appointing notified bodies. Said body, together with the representatives consulted, shall produce within 45 days after the on-site assessment an assessment report containing, among other things, a recommendation with regard to the designation. The assessment reports shall be made available to all other Member States. The assessment reports of the consulted representatives of other designating authorities, as well as any further comments by designating authorities, by competent agencies of other Member States and by the Commission, are merely recommendations and are not binding. Nevertheless, it is anticipated that the deciding authority will have difficulty ignoring negative comments without good reason.
  • The Member States will monitor and audit the notified bodies at regular intervals (performing file reviews, on-site assessments and audits) to ensure that they fully comply with the requirements. If this is not the case, the Member State shall withdraw its designation of the body.
  • The requirements on the skills and competence of the personnel of notified bodies are explained.
  • The notified bodies will perform unannounced, random internal audits checking relevant samples. If the notified body fails to check random samples, its designation will be suspended or withdrawn.

Content of Commission Recommendation of 24 Sept 2013

This Recommendation does not introduce new duties, but is intended to ensure the proper monitoring by the notified bodies of the manufacturer’s compliance with legal requirements. By providing general guidelines for assessments and unannounced audits, the work of the notified bodies, as well as the Member States’ evaluation thereof, is to be facilitated. Since the notified bodies do not have the powers of a public authority, the relevant details will be stipulated in the agreements entered into by the notified bodies with the medical device manufacturers seeking product certifications.

The Recommendation contains detailed instructions under the following headings:

  • Annex I: Product assessment;
  • Annex II: Quality system assessment;
  • Annex III: Unannounced audits.
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