The TOPRA Annual Symposium is seen as one of the most important events for European regulatory professionals, as the largest forum to discuss current regulatory issues and debate the future of regulations.
Last week Nerudia attended the symposium which focused on ‘Global regulatory approaches to improving healthcare.’
There are significant changes ahead for medicinal products incorporating device components, and as a result there was a lot of debate about the new European Medical Device Regulation (MDR) and what this means for manufacturers, notifying bodies and member state competent authorities.
What is the new European Medical Device Regulation (MDR)?
On 5 April 2017, two new Regulations on medical devices were adopted to replace the existing Directives. The new regulations entered into force on 25 May 2017.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
The regulation covers medical devices and active implantable medical devices. Its requirements pertain to the European Commission, as well as manufacturers, Notified Bodies and member state competent authorities.
When do the changes come into effect?
The new rules apply after a transitional period, 3 years after entry into force for the Regulation on medical devices (25 May 2020) and 5 years after entry into force (25 May 2022) for the Regulation on in vitro diagnostic medical devices.
Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
In addition there will be a new designation process for Notified Bodies, which includes reinforced requirements in terms of resources and assessment of manufacturers, as well audits by a Joint Assessment Team delegated by the EU Commission.
Why was it such a hot topic?
The new European Medical Device Regulation (MDR) is almost three times as long as, and much stricter than, the previous Medical Device Directive (MDD). The changes are significant and will impact manufacturers, Notified Bodies and member state competent authorities.
The changes include increased scrutiny of technical documentation, address concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and require better traceability of devices through the supply chain.
Contact us for more information on how we can help you interpret what the changes mean for your business.