The current EU Medical Devices Directives will soon be replaced by new EU IVD and Medical Device Regulations. The new regulations are expected to be adopted and published within 12 months, with implementation from 2015 to 2018. This has significant impacts on clinical, biocompatibility, preclinical performance and other technical requirements. For IVDs, it is uncertain whether the transition period will be 3 or 5 years, meaning that the final implementation date could be 2018 or 2020.
The PIP (Poly Implant Prothése) scandal along with problems occurring with metal-on-metal hip joints caught the attention of the EU public at large on the safety management of medical devices. As a result, the European Parliament issued a Resolution in June 2012, which called for stricter approval rules for Notified Bodies, stronger requirements for preclinical and clinical evaluation of medical devices and mandated unannounced inspections of medical device manufacturers. These and many other changes are described in the EU Commission proposed IVD and Medical Device regulations dated September 26, 2012 and Parliament’s IVD and Medical Device amendments on October 22, 2013.
Although the regulations have not been finalized, changes are already being felt as a result of the European Parliament and European Commissions efforts. Until 2011, more than 30% of Class III and 40% of Class IIb medical devices in Europe were marketed without clinical studies of any sort. Now Notified Bodies are challenging clinical evidence not only for new higher risk class III and IIa devices but also existing devices that have been CE Marked since the inception of the Directives, even those that are lower risk class IIa and I sterile/measuring devices.
Additionally, immense pressure has been applied to the Notified Bodies and Competent Authorities that are charged with designating and oversight of the Notified Bodies in the member countries. Information about the performance of Notified Bodies was published on June 17, 2014 in a document“Commission Staff Working Document” that reports on the European Commission’s implementation of the Joint Plan for Immediate Actions under the existing medical devices legislation. Audits of several Notified Bodies conducted from February 2013 to May 2014 revealed weaknesses among some of them and also for one of the Competent Authorities. Consequently, there are a few less Notified Bodies than there were a few years ago, and the ones that remain are much more vigilant.
Unannounced audits have become more common since the Commission Recommendation on Notified Body audits of September 24, 2013, which clarifies the authority of Notified Bodies to carry out unannounced audits of medical device manufacturers. Although TUV Rhineland has been performing unannounced audits for some time now, other Notified Bodies, most notably BSI, have conducted numerous unannounced audits over the past few months.
Until now, the EU regulatory system enabled Europeans access to innovative medical technologies earlier than Americans; this may no longer be the case.
What should manufacturers plan for?
- Dedicated personnel and action plan.
- Securing Regulatory Affairs resources: “Qualified Person” + new resources for additional work.
- Check that they have selected the right Notified Body.
- Increased internal and external training to ensure full compliance to the more stringent requirements including those related to material safety (i.e., biocompatibility and clinical data.
- Prepare for higher costs for the overall assessments and submission fees.
- Prepare for longer review times for all devices, especially class III devices, class IIb implantable devices and novel devices.
- Review clinical data evaluation – get prepared for clinical investigations for certain device types; specifically Class II and implantable Class IIb devices.
- Updating Technical Files to meet the more rigorous requirements by the implementation date.
- Establish SOPs (Standard Operating Procedures) and training for handling unannounced Notified Body inspections of themselves and critical suppliers.