03 August 2023
The Department of Health & Social Care (DHSC) has approached the BDIA for feedback in relation to two recent pieces of legislation:
- The Medical Devices (Amendment) (Great Britain) Regulations 2023
- The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023
Under the Medicines and Medical Devices Act 2021 (MMD Act), there is a legislative requirement on DHSC to publish a report on the operation of any regulations made using the MMD Act powers every two years. As part of this report, DHSC is collecting views from stakeholders on how the regulations are working in practice, as well as any concerns, proposals or general feedback about the regulations themselves.
The Medical Devices (Amendment) (Great Britain) Regulations 2023
This is the Statutory Instrument that has extended the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. As a result, eligible devices compliant with the EU MDD may be placed on the GB market up until the sooner of expiry of the certificate or 30th June 2028, while eligible devices compliant with the EU MDR can be placed on the GB market up until the sooner of expiry of certificate or 30th June 2030.
Class I medical devices under the Directives, for which the conformity assessment under the EU MDD did not require a Notified Body, can only be placed on the Great Britain market if the involvement of a Notified Body would be required under the EU MDR (i.e., if it is an upclassified device or a reusable surgical instrument Class I device). Custom-made devices that are compliant with the EU MDD or EU AIMDD can no longer be placed on the Great Britain market.
The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023
This legislation gave effect to a range of change to the MHRA’s statutory fees following a public consultation in August 2022. The proposals included a 10% indexation uplift across all of the MHRA’s statutory fees, a further uplift for a range of “significantly under recovering fees” in order to achieve cost recovery as well as the introduction of new fees.
Notable for manufactures was the increase in MHRA device registration fees from £100 to £240.
Responses can be made using the forms available via the links below. If you would like to provide your feedback, please complete the forms and return to email@example.com by 24th August 2023.