OSA response to MHRA consultation / 12 October OSA MDR meeting
The MHRA launched its consultation on the future regulation of medical devices in the United Kingdom on Thursday 16 September 2021. The intention is for these new regulations to come into force on 1 July 2023. The consultation will run until 11:45pm on 25th November 2021.
The OSA will be responding to the consultation and welcomes input from members. To facilitate that we will review the consultation documents and provide a summary briefing of key relevant points to members in the next few weeks.
The consultation covers a broad scope, not all of which is directly relevant to OSA members. The chapters of the report cover the areas set out below. We will review the whole document, but as a minimum the OSA expects to respond to those marked in bold:
- Scope of the regulations
- Economic Operators
- Registration and UDI
- Approved Bodies
- Conformity Assessment
- Clinical Investigation/Performance Studies
- Post-market Surveillance and Vigilance
- In vitro Diagnostic Medical Devices
- Software as a Medical Device
- Implantable Devices
- Other Product-Specific Changes
- Environmental sustainability and public health impacts
- Routes to market
- Transitional Arrangements
If you wish to access the document in full you can download it here:https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom
The MHRA are holding a webinar presentation for industry on the content of the consultation on Tuesday 5 October 10.30-11.30. You can find more information and book a place here:https://www.eventbrite.co.uk/e/mhra-consultation-on-future-medical-devices-regulation-in-the-uk-industry-tickets-166144503683 They may hold more seminars if there is sufficient demand. The seminar will also be recorded and available to view shortly afterwards on YouTube.
The OSA will hold a MDR Forum meeting on Tuesday 12 October between 11.00-13.00 at which Ann Blackmore, our policy advisor, will summarise the proposals in the consultation.