Latest Update – 11th April 2023
Further to our previous update please see additional detail below, following the amendment which was published on the EU website on 15th March.
- For class III and class IIb implantable devices, the CE under MDD is extended to 31st December 2027.
- For class I (measurable), class I (sterile), class IIa and class IIb (other than implantable) this is 31st December 2028.
- Devices that did not require a notified body (but will do so under the MDR) have been given a date at which they can be placed on the market up to 31st December 2028, However, for these, the declaration of conformity had to have been to be drawn up prior to 26th May 2021.
The government are due to release more details regarding the future of the UK medical device regulations. The current timeline is outlined by the publication of three statutory instruments (SIs) which will cover:
- Transitional arrangements – expected Spring 2023, which will introduce transitional arrangements for CE marked devices (expected to be 3 years for devices under the MDD and 5 years under the MDR)
- Post Market Surveillance – expected Summer 2023, to be implemented late 2023/early 2024 with a 6 month implementation period and an anticipated close alignment to the PMS requirements under the MDR
- Future UK MDR – expected Winter 2023/2024 with implementation in July 2024
Regarding software and artificial intelligence, MHRA have indicated a roadmap which promises to offer a pragmatic and flexible approach. It is likely to be in line with international harmonisation and international medical device regulators forum. One interesting aspect to this is the exploration of an airlock process which will allow software to generate real world evidence for a limited period of time, while being continuously monitored.
There is also the potential concept of alternative routes to market – domestic assurance, and more powers for MHRA to directly approve highly novel or innovative devices. This appears to be a focus of the new Innovative Devices Access Pathway (IDAP), which is a joint project between NICE, MHRA, Health Technology Wales and the Scottish Health Technology Group. IDAP will offer a supported access route both for innovative medical technologies and digital devices that meet critical needs within the NHS. This might provide an opportunity for accelerated regulatory approval and reimbursement for impactful technologies.
Patrick Trotter and Stefanie Lowry, Medilink North of England
If you are needing any advice or support navigating these requirements, get in touch with our specialist consultancy team [email protected]