The New Medical Device Regulation in ten points What are the challenges for manufacturers?
After a prolonged and difficult process, agreement has finally been reached over the new European Union Medical Device Regulation (MDR) and was published in the Official Journal of the European Union on 5th May 2017.
The MDR is a fundamental revision of the earlier directives and is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. The changes which the MDR embodies are significant – this article will outline the top ten challenges that regulated companies and manufacturers can expect to overcome, and will offer practical insight to help these companies prepare for this unprecedented change in the European regulatory environment.
MDR: THE GENERAL PICTURE
After a long period of review and refinement, the new European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union on 5th May 2017. The MDR is a ‘fundamental revision… of the earlier Directives [and] is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’. This new regulation, which has been troubling the thoughts of many compliance professional and medical device manufacturers, replaces both the previous Medical Device Directive and the Active Implantable Medical Device Directive (90/385/EEC) and has binding legal force throughout the EU and entering into force simultaneously in all the Member States.
A recent survey of industry professionals by Emergo found that (1):
- Most respondents are aware of coming changes to the European CE marking process as well as to the ISO 13485 quality system standard, but primarily on a high level.
- The majority of participants cited changing regulatory enviro ... ...