The European Commission has published two new measures aimed at improving the safety of medical devices. The new rules are a Regulation strengthening the criteria to be met by notified bodies and a Recommendation clarifying the tasks these bodies have to undertake when they perform audits and assessments in the medical devices sector.
The measures adopted this week were announced in the Joint Plan for immediate action agreed between the Commission and the EU Member States, in which MHRA played an active role. The plan focuses on the functioning of notified bodies; the surveillance by the Member States of the products on the market, EU coordinated investigations and responses to problems with specific devices as well as improved transparency and communication between Member States, industry, health professionals and notified bodies.
Examples of the strengthened requirements laid down in the measures adopted today:
- a Member State shall only designate a notified body after a ‘joint assessment’ conducted with experts from the Commission and other Member States. The assessment reports shall be made available to all other Member States.
- Member States are required to carry out surveillance and monitoring of the notified bodies at certain intervals to ensure that they continuously live up to the requirements. If this is not the case, the Member State must withdraw the designation as notified body.
- knowledge and experience requirements of the staff of the notified bodies to be required by Member States are clarified.
- it is now required that notified bodies shall randomly perform unannounced factory audits and, in this context, check adequate samples from the production. Failure to carry out random checks will result in the suspension or the withdrawal of the designation of the notified body.
- where risks might be caused by the substitution or adulteration of raw-materials, such as in the PIP-case, a notified body shall also check that the quantity of finished products corresponds to the quantity of the crucial raw material purchased.
The full Regulation and Recommendation can be found at the European Commission website (external link)