New regulations on medical devices in Europe: what to expect?

Abstract

Medical devices (MDs) contribute to improve quality and effectiveness of healthcare. The MD industry is a heterogeneous, innovative, dynamic and growing sector. The existing regulatory framework for MDs has been in place for 20 years and needed a revision. In September 2012, the European Commission published a proposal for a new regulation on MDs which was amended by the Parliament in October 2013. This new regulation aims to harmonize practices, increase transparency and guarantee a high level of health protection. We conducted an analysis of the proposal to highlight the major upcoming changes.

Keywords::

• CE marking
• clinical investigations
• European regulation
• medical device vigilance
• medical devices
• transparency
• unique device identification

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• In September 2012, the European Commission published a proposal for a new regulation on medical devices (MDs) which was amended by the Parliament in October 2013.

• New stakeholders will be defined: the person responsible for regulatory compliance designated by the manufacturer, the European references laboratories and a new European organization with the MD coordination group, the assessment committee for MDs and the MD advisory committee.

• For the first time, a European control is introduced for notified bodies designation and monitoring and also for high-risk MD CE marking.

• Regarding clinical investigations, sponsors will have to register investigations in an European database. But most of all, a simplification of the application process to national competent authorities for investigations conducted in several member states will be observed.

• The regulation will strengthen vigilance and post-market surveillance, for example, unannounced audits by notified bodies or collection of serious incidents and corrective actions in an European database.

• The unique device identification system will be implemented enabling MD tractability and access to information on MDs.

• The transparency of the MD sector will be enhanced with, for example, safety and clinical performance report for high-risk MDs or public access to European Database on Medical Device.

• The new regulation on MDs will strengthen the legislative framework and harmonize practices within the Member States. The text should be adopted in 2015 and will be applied within 3 –5 years after its publication.

Notes

MD: Medical device; NB: Notified body.