The MHRA is convening five different focus groups to help shape the guidance documents and other supporting materials that will accompany the new MDR. The idea comes after a 10-week public consultation launched in September last year, covering proposals on the future regulation of medical devices in the UK.
The topics that could be discussed as part of these focus groups are as follows:
- Classification rules (medical devices and IVDs)
- Essential requirements
- Health Institution Exemption
- Distance sales (medical devices and IVDs)
- Obligations on economic operators
- UDI requriements
- Obligations on Approved Bodies
- Transparency of conformity assessments
- Equivalence
- Performance evaluations
- Clinical investigations
- Post-market
- Post-market surveillance requirements
- Reporting of serious incidents
- Genetic testing obligations
- Companion diagnostics
- Software as a medical device
- Implantable devices
- Re-manufacturing of single-use devices
- Custom made devices
- Routes to the UK market
- Transitional arrangements
The list is not exhaustive – if you have some other suggestions on what else these discussions should cover, please let us know at [email protected].