European Commission Interim Measures
Partly in response to the PIP incident but prior to the French court?s ruling above, the European Commission introduced interim measures relating to the medical devices sector on 25 September 2013 (see Commission Implementing Regulation 920/2013, and non-binding Commission Recommendation 2013/473/EU).
The measures include a requirement on notified bodies to conduct unannounced inspections of manufacturers and to check samples, as well as rules on conflicts of interest. Importantly the measures require notified bodies to ensure that they are properly resourced, whether that involves the assistance of subcontractors or subsidiaries or not, and that their staff are fully qualified to carry out the assessments required. In particular there are restrictions on what may be subcontracted by notified bodies. The measures also require Member States and the Commission to take a more active role in the assessment, regular surveillance, monitoring and investigation of notified bodies.
What does this mean for industry?
If courts in other Member States adopt a similar approach, this decision signals that the potential liability exposure of notified bodies? cannot be confined to contractual risks alone. Nor can a notified body necessarily rely on the fact that a manufacturer has acted fraudulently as a defence as the court may consider the fraud to have been discoverable by an appropriately thorough inspection, as in this case.
The French court recognised a wide public duty on the part of notified bodies by reference to the MDD, which appears to be owed not only to end-user patients but also to distributors. If notified bodies fall short of this duty, then they may face significant damages claims from both distributors and patients. Given the scale of distribution of products such as the PIP breast implants, overall liability could be significant. Notified bodies will therefore likely need to review their insurance coverage. These costs will necessarily have to be passed on to industry and ultimately commissioners and consumers.
For manufacturers the increased potential liability exposure of notified bodies and the requirements imposed through the interim measures is likely to mean that applications for certification will have a longer turnaround and that reviews and audits will be more expensive as well as more challenging. Ultimately this may well mean that products will take longer to get to market and that costs will increase. If, as expected, there is a consolidation of notified bodies (i.e. fewer in total, with less capacity between them) industry may also experience a ?bottle-necking? of applications, particularly once the MDD revisions are effective requiring notified body-reviewed upgrades to existing, as well as new, product dossiers.