In September 2012, the European Commission proposed legislation to modernize and expand the medical device directives and upgrade them to regulations.  Two separate proposed regulations were put forward:

  • Proposal 542: applies to medical devices and active implantable medical devices  (a combination of the current MDD and AIMDD directives)best-case scenario timeline review and adoption process for new device directives
  • Proposal 541: applies to in vitro diagnostic medical devices (similar to the current IVDD directive)

The proposed regulations have been issued at the same time and are closely related.  For this reason, they can only come into force as a double pack.

Both regulations were routed to the Committee on the Environment, Public Health, and Food Safety and assigned to different rapporteurs. In April of 2013, the rapporteur reports were released in draft form – although the overall tone of the opinions is unlikely to change.

While the in vitro diagnostic medical device directive appears to require only minor modifications, its forward movement may be stopped until the question of a centralized device authority is resolved.

The rapporteur reviewing proposal 542 (medical devices and active implantable medical devices) felt strongly that devices presenting the highest potential risk for patients (eg, all class III devices, devices that include a medical product, and devices that use non-viable tissues or cells of human or animal origin or their derivatives) should be subject to more stringent assessment procedures than those currently being proposed.  She recommends a new marketing authorization procedure for the highest-risk devices, which would be centralized for innovative products and decentralized for all other qualifying devices.

The Commission estimates that regulations would be adopted in 2014 and gradually implemented between 2015 and 2019.  Device development programs nearing completion in 2013 should be able to proceed unhindered.  I recommend being proactive and starting to follow the new regulations as soon as they become available.

However, sponsors in the early to middle stages of development would be wise to incorporate the proposed legislation into their planning process. While implementation and oversight processes of the draft medical device regulations may vary, fundamental aspects are unlikely to change significantly

Interested in learning more? The slides from our recent Navigating the Challenges of the Modernization and Expansion of EU Medical Device Regulations webcast are available for download and I will be publishing an upcoming ebook on the subject.  If you’d like to be alerted when the ebook is available, please leave your contact information in the comments section.