A new EU Medical Device legislation was proposed in September 2012 by the European Commission. The Parliament’s Environment, Public Health and Food Safety (ENVI) Committee provided multiple amendments and the Parliament adopted many of these amendments this past October 22, 2013. It now goes before the European council, where the Public Health Committee will vote on it and then the full house. In parallel, European Commission recommendations were published in the September 25th edition of the EU Official Journal to clarify some tasks performed by the Notified Bodies and will be applicable early 2014.
The proposed regulation is expected to be finalized by April 2014. Some changes may happen by then, however, 80% of the current content is likely to remain unchanged and overall the regulation should come into force from 2015 to 2018.
The future legislation aims to keep rapid access to the market, remain cost effective, and continue to be supportive of innovation while providing enhanced protection of public health healthcare professionals. For example, public healthcare professionals will be provided with better information on the benefits for patients, residual risks, and the overall risk/benefit ratio. The goals are to evaluate more data (clinical and non-clinical), to coordinate communication among member states, and improve harmonization of the Notified Bodies for more competent and timely reviews of biocompatibility data. To some extent, manufactures will benefit from clearer rules, ease of trading among member states, and a level playing field that benefits innovative small and medium-sized manufactures.
It is in the best interests of device manufacturers to prepare for the regulatory changes as soon as possible. To prepare for the phasing in of these regulations it is recommended to:
- Secure regulatory authority resources.
- Increase training to ensure full compliance in Biocompatibility Assessments.
- Update submission files before the 2017 due date of the application.
- Prepare for higher costs of the overall assessment and submission fees.
More information on the new proposed European Medical Device legislation can be read about in the white paper EU Medical Device Regulatory Framework: Practical Impact of New Regulations. To ensure you are prepared, contact us, and we will work with you to ensure a smooth transition to market under these new proposed regulations.