Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.
There are currently over 500,000 different medical devices and in vitro diagnostic medical devices on the European market.
On 5 April 2017, two new regulations on medical devices were adopted. These replace the existing directives.
- 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 invitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
The new rules will only apply after a transitional period. Namely, three years after entry into force for the regulation on medical devices (spring 2020) and five years after entry into force (spring 2022) for the regulation on in vitro diagnostic medical devices.
- Biggest regulatory change in 20 years.
- No grandfathering. All devices must be registered.
- All devices must have clinical evaluation.
- Number of Notified Bodies reducing.
- Predictions of 95% of all IVDs to be checked by Notified Bodies prior to being placed on market.
- Device to be registered only once at EU level.
What are the Challenges?
- Availability of clinical data.
- First interaction with Notified Body for some companies.
- Post market surveillance.
- Resources – industry and Notified Bodies.
What Steps Do You Need to Take?
- Talk to your Notified Body…what are their plans?
- Start collecting and evaluating post market data.
- Gap assess your product portfolio.
- Consider rationalisation of product portfolio.
- Develop product family strategies.
- Get senior management buy in.
- Talk to your supply chain.
Do you have questions about these new regulations? Click below to contact us. Select GMP - Quality, Compliance, and Regulatory to get your questions directed to John Henchion, the Business Area Lead.