From incorporating device sterilisation into a full design and development project to utilising our 'plug...
Confused or apprehensive about all the changes coming to medical device regulations following Brexit? Not to worry, Mi3 is here to help.
On 1 September 2020, the MHRA published new guidance on the regulation of medical devices that will be applicable from 1 January 2021, after Brexit transition, and choosing not to follow the MDR (which would have been mandated had there been no delay in implementation of MDR in May 2020). Therefore, the UK will have its own regulatory requirements as of 1 January 2021, and it will include a number of changes to how medical devices and IVDs are placed on the market in Great Britain.
Changes of note are:
- Current CE marking will continue to be used and recognised until 30 June 2023.
- Certificates issued by Notified Bodies based in the European Economic Area will continue to be valid in the UK until 30 June 2023.
- A new regulatory pathway to market and new product marking (the UKCA mark replace the CE mark) will be available for manufacturers wishing to place a device on the market in Great Britain from 1 January 2021.
- Medical devices placed on the market in Great Britain will need to have either a UKCA mark or a CE mark on their labelling, depending on which legislation the device has been certified under.
- All medical devices and IVDs placed on the market in Great Britain must be registered with the MHRA.
- If you are a manufacturer based outside the UK and wish to place a device on the market in Great Britain, you will need to designate a UK Responsible Person that is established in the UK.
How can Mi3 support you?
If you are established outside of the UK and wish to continue placing your devices on the market in Great Britain, you will have to develop an action plan to meet all the new requirements. Mi3 can support you in this area. For companies based in the UK, let us help optimise your approach to ensure efficiencies of efforts to meet your global regulatory needs.
For more information, please fill out the enquiry form attached to this page.
The new Regulation consolidates two existing legal provisions and replaces both the MDD and the...
Ultrasonic welding is the joining of two thermoplastic components using high-frequency welding to melt the...