On Tuesday 24 September 2013, the European Commission adopted a Regulation intended to strengthen the criteria for the designation and supervision of notified bodies under the Medical Devices Directives[1]. On the same day, the European Commission also adopted a Recommendation concerning the tasks to be fulfilled by notified bodies when conducting audits and conformity assessment procedures[2].

These measures were adopted to respond, among others, to the Poly Implant Prothèse (PIP) breast implants scandal by improving the safety of medical devices and restoring patient confidence in the medical device sector.

Commission Regulation

The Regulation issued by the European Commission substantially changes the procedure for designating notified bodies. According to the new rules, assessment of notified bodies will be conducted by a joint assessment team composed of an expert from the European Commission, the designating authority of the EU Member State in which the notified body is established and the designating authorities of two other EU Member States’.

Following an on-site audit, the designating authority of the notified body shall produce an assessment report. The expert from the European Commission and representative of the two other EU Member States shall also prepare a similar report. The assessment reports shall be made available by the Commission, upon request by other EU Member States.

When the designating authority of the EU Member State where the notified body is located takes its decision on designation, it shall take into account the recommendations from the other members of the joint assessment team and any other EU Member State.

The Regulation also includes provisions concerning the surveillance and monitoring of notified bodies by the designating authorities of the EU Member States’. This includes the possibility for the designating authorities to conduct unannounced on–site assessments of the notified bodies. 

Commission Recommendation

The Recommendation published by the European Commission is intended to promote the consistent application of conformity assessment procedures by notified bodies. It lays down general principles related to the requirement that notified bodies perform unannounced audits and inspections of manufacturers, critical subcontractors and crucial suppliers. Although a Recommendation is not legally binding in the European Union, it is likely that the EU Member States will require notified bodies to respect the provisions of the Recommendation. The key elements of the Recommendation include the following:

  • Notified bodies should review all relevant preclinical data, the clinical evaluation and the post-market clinical follow-up undertaken or planned by a manufacturer;
  • Notified bodies should verify that the manufacturers’ quality system ensures traceability of materials and components from the manufacturer, supplier and subcontractors’ premises to the final product. In a direct response to the PIP breast implants scandal mentioned above, the notified body should also check that the quantity of finished products corresponds to the quantity of the crucial raw material or components purchased or produced;
  • Notified bodies shall carry out unannounced audits, including checking a sample of the devices, in the premises of manufacturers, critical subcontractors or crucial suppliers at least once every three years.  The contractual arrangements between the notified bodies and manufacturers should include specific provisions concerning these unannounced audits. This should include a provision providing that the notified body has a right to terminate the contract if access to the manufacturer, subcontractor or suppliers’ premises is no longer assured.