With the UKCA deadline fast approaching and updating the existing regulation UK MDR 2002, MHRA has conducted a public opinion forum,
Some of the key highlights are stated below, for your quick review.
Transition Timeline
The significant update on this forum discussion is the Transition timeline of July 2023 has been moved.
The revised timeline is an extra 5 years for CE-marked products issued against EU MDR/IVDR, and an extra 3 years for CE marked under EU MDD and 5 years under EU IVDD.
There are a couple of caveats to this, but these are expected.
- Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions
- All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements
MDSAP consideration for MHRA:
Additional to CE certification, UK MHRA will consider MDSAP certification as an alternative route to market to UK.
Caveat:
- UK MHRA will require UK Approved bodies to consider MDSAP assessments.
- Domestic assurance routers will allow an abridged assessment with scrutiny and Approved bodies will be able to reject if they consider sufficient evidence is not provided.
Classification:
Under the upcoming new regulation, MHRA is considering updating the Classification of Medical devices as well as In Vitro Devices(IVD) and Assisted reproductive technologies (ART)
And devices with nanoparticles will be moved between Class IIa -III depending on the risk involved.
Traceability:
MHRA will be bringing our requirements for economic operators to identify and record the following information:
- Any economic operator to whom they have directly supplied a medical device
- Any economic operator who has directly supplied them with a medical device
- Any public or private sector health institution or healthcare professional to which they have directly supplied a medical
This will provide more traceability of the product.
Currently, this doesn’t state where and how the record needs to be maintained so we would ask the manufacturers to maintain this record and provide the same to us (UKRP) on a monthly basis for our records.
On the whole, MHRA is considering its new regulation to be in line with EU MDR/IVDR in certain aspects, we will know more when the new regulation is released and consider the above as MHRA’s view on changes to be made based on the public opinion.
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.