February 2025 Medical Device Regulatory Update

1 February – Laura Squire OBE Departs MHRA

• Laura Squire leaves her role as Chief Healthcare Quality and Access Officer.

• The Innovative Devices Team now reports to the Innovation and Compliance Group, led by Interim Director James Pound.

• Pound’s analytics background expected to bring a data-led approach to innovation.

3 February – Digital Mental Health Technologies (DMHT) Guidance Released

• New MHRA guidance ensures DMHTs like apps, AI tools, and VR therapy are safe, effective, and regulated.

• DMHTs with a medical purpose must be regulated as Software as a Medical Device (SaMD).

• Risk classification and evidence requirements clearly outlined.

• Guidance developed with input from NICE, NHS, and Wellcome Trust.

17 February – Device Registration Guidance Updated

• MHRA guidance now reflects:

• IVDR transition extension under Article 110

• EU MDR transition updates under Article 120

• All devices must be registered before entering the GB market.

17 February – Extended Validity of Certain CE Certificates

• CE certificates extended:

• Until 31 Dec 2027: Class III and certain Class IIb implantables

• Until 31 Dec 2028: Class IIa, Im, Is, Ir

• GB market acceptance extended:

• Medical Devices: Until 30 June 2028

• IVDs: Until 30 June 2030

• Expired certificates may still be valid if a conformity contract was in place pre-expiry.

26 February – Updated Draft Policy on International Recognition

• Draft framework to accept approvals from Comparable Regulator Countries (CRCs).

• Conditions include:

• English labelling

• Same design/purpose as in CRC

• UDI compliance

• UK Responsible Person

• PMS compliance

• Not applicable to custom-made or in-house devices.

26 February – Consultation Response on Assimilated EU Law

• 287 responses reviewed on whether four expiring EU laws should remain:

• Common specs for IVDs

• eIFUs

• Animal-origin device rules

• Supervision of Approved Bodies

• 83% supported keeping these in force.

• Legislation to follow.

Upcoming – 5 March – ILAP Webinar on Drug-Device Combos

• ILAP refresh webinar covers streamlined access pathways.

• Particularly relevant to drug-device combination products.

• ILAP involves MHRA, NHS, and HTA bodies.

1 February – Tariffs Imposed on Canada, Mexico, China

• Tariffs include:

• 25% on Canada and Mexico

• 10% on China

• Industry warns of supply chain disruptions and cost increases.

• AHA and AdvaMed push for medical device exemptions.

• Tariffs on Canada and Mexico resume 4 March.

5 February – FDA Alert on Diabetes App Notifications

• Some smartphone-connected glucose monitors failed to alert users.

• Reports of hypoglycemia, hyperglycemia, and death.

• Users advised to check phone and app alert settings regularly.

13 February – RFK Jr Sworn In as HHS Secretary

• Launches “Make America Healthy Again Commission” via Executive Order.

• Expected shift to stricter device oversight, potentially extending timelines and costs.

• Emphasis on public trust and transparency.

24 February – Medtronic DBS Device Approved

• BrainSense Adaptive DBS device for Parkinson’s approved.

• Offers real-time personalised stimulation based on brain activity.

• Medtronic expects strong growth from the launch.

24 February – FDA Rehires CDRH Reviewers

• Initial layoffs affected over 200 CDRH staff under new Trump efficiency drive.

• Backlash from industry (AdvaMed, AHA) led to partial rehiring.

• User-fee funded roles mistaken as taxpayer funded.

6 February – Coordinated Clinical Investigation Pilot Launched

• Enables single applications for multi-country device trials.

• Voluntary until 2027 (MDs) / 2029 (IVDs).

• 20 countries participating; open for Class II and IIb trials.

• Interest deadline: 30 June 2025.

7 February – MDCG 2019-6 Rev 5 Released

• Updated guidance on notified body conduct.

• Clarifies:

• Conformity application procedures

• Equipment expectations

• Supplier auditing

• Structured dialogue topics

17 February – High-Risk Device Advice Portal Ongoing

• EMA offers free scientific advice for Class III and active Class IIb MDs.

• Aims to support clinical strategy and trial design.

• Full report expected soon.

21 February – Draft Act Consultation on eIFUs Open

• Public consultation open until 21 March 2025.

• Discusses making instructions for use digital-only for professional users.

• Mixed feedback so far: sustainability vs update control risks.

Ongoing – Consultation on MDR/IVDR Effectiveness

• Seeks stakeholder input on how well the regulations have worked.

• Open until 21 March 2025.

• Early feedback highlights issues for SMEs and unintended impacts on access.