In 2012, following the scandal of defective implants manufactured by the French company PIP, the European Commission and EU Member States agreed on an action plan (PIP Action Plan) under which surveillance of medical devices was intensified in Europe on the basis of existing law. Swissmedic has also initiated action. This involves more stringent requirements for the Notified Bodies (NB) and may have consequences for suppliers of medical devices.
The Europe-wide intensified market surveillance activities stemming from the PIP Action Plan are starting to have an effect. The fleshing out of requirements has resulted in certain NB in Switzerland and Europe deciding to discontinue their medical device certification activities.
If an NB discontinues activities in this area and does not renew its designation (issue of EC certificates for medical devices), the EC certificates issued under this designation lose their validity when it expires. As a consequence, the products in question may no longer be placed on the market for the first time. (Products that were already on the market before the NB discontinued its activity may still be marketed).*
Primary responsibility for guaranteeing a medical device's conformity with the applicable national and international legislation rests with its manufacturer. Depending on how the medical device is classified, the manufacturer has to ask an NB that is entitled to issue certificates within the designated scope (Annex XI of Directive 93/42/EEC) to assess conformity.
What should companies that manufacture affected medical devices be aware of?
Affected companies can have medical devices that satisfy the relevant requirements certified by another NB. Manufacturers in Switzerland and the EU can choose one of the almost 70 European NB, provided the NB is designated for the process and product category in question.
All NB that are entitled to issue EC certificates in the medical devices sector are listed in the EC's NANDO database with their scope (MD scopes, e.g. MD 0106 for non-active instruments).
Swissmedic emphasises that the Agency is not a party to contracts between the private-sector NB and manufacturers and has no influence on the product certification process. Furthermore, affected manufacturers should generally allow several months to change NB and obtain the appropriate new assessments.
Swissmedic is the Swiss agency responsible for post-marketing surveillance of medical devices. It performs risk-based, random tests of medical devices marketed in Switzerland for the purpose of assessing their conformity and as such discharges a subsidiary inspection duty for the state.
*Clarification added on 28 January 2015
The NANDO (New Approach Notified and Designated Organisations) Information System contains lists of and information about all Notified Bodies within the EU