January 2025 Medical Device Regulatory Updates

2 January – Professor Harnden Begins Role as MHRA Chair

• Professor Anthony Harnden officially takes over as Chair of the MHRA.

• Key priorities:

• Patient safety through strong surveillance systems

• Risk-proportionate regulation

• Inclusive and flourishing workplace

• Keeping the UK a global life sciences leader

• Brings 40 years of NHS experience to the role.

13 January – Progress Report on MHRA Patient Involvement Strategy

• Reflects on progress since 2021 launch.

• Key themes for medical devices:

• Patient-centred regulation

• Faster issue detection via feedback

• Better communication and transparency

• Continuous strategy improvement

• Inclusive engagement across diverse patient groups

15 January – PMS Guidance Suite Released

• Supports new Post-Market Surveillance (PMS) regulations (effective 16 June 2025).

• Clarifies:

• PMS definitions and reportable events

• CAPA notifications

• PSUR format and timings

• Public and patient feedback integration

• Obligations based on device type

• Applies to England, Scotland, Wales only.

16 January – House of Commons Debate on MHRA Performance

• Concerns raised about:

• Primodos case

• Yellow Card adverse reaction reporting

• MHRA’s industry funding sources

• Delayed vaccine side-effect responses

• Call for full implementation of Cumberlege Review (IMMDS) recommendations.21 January – Scientific Advice Service Improvements

• Streamlined process for advice requests:

• Digital application form

• More written responses

• Payment and document submission due 3 weeks before meeting

• MHRA may provide written summaries post-meeting.

27 January – Industry Insights on NHS Digital Future

• Health Tech Now webinar covered:

• Digital integration of devices with EHRs

• Proactive care via remote monitoring

• Interoperability and real-time data sharing

• Growth of tech-enabled care in community settings

6 January – FDA Issues Draft Guidance on AI Device Lifecycle

• Focused on full lifecycle management of AI-enabled devices.

• Covers:

• Design, development, maintenance, and risk documentation

• Supplements the final guidance on PCCPs for AI

6 January – Draft Guidance on Pulse Oximeters Released

• Responds to concerns over accuracy across skin tones.

• Includes:

• Pre-market testing requirements

• Labelling and risk communication

• Lessons learned from COVID-19 usage

15 January – LDT FAQs Released

• Clarifies regulatory oversight of Laboratory Developed Tests (LDTs).

• Covers:

• Premarket review

• Reporting requirements

• Labeling and investigational use

16 January – FDA Addresses Device Shortage Concerns

• Highlights disproportionate impact on vulnerable groups (e.g. children).

• Requests statutory authority to strengthen FDA’s ability to prevent shortages.

17 January – CDRH 2024 Annual Report Published

• Key milestones:

• Record novel device approvals

• Expanded Home as a Health Care Hub initiative

• Strengthened global collaboration (IMDRF)

• Enhanced diverse trial participation

20 January – Outgoing FDA Commissioner Warns of Misinformation

• Robert Califf warns about public misinformation during pandemic.

• Supports non-interventionist policy in regulatory decisions.

• Sara Brenner named Acting Commissioner.

24 January – Trump Announces New 10% Tariff on Chinese Goods

• Medical devices included, effective 1 February 2025.

• Likely impact:

• Increased costs and reduced accessibility

• Supply chain disruptions

• Potential for retaliatory trade measures

30 January – RFK Jr. Faces Senate Confirmation Hearings

• Nominee for HHS Secretary under scrutiny for vaccine views.

• Faces opposition across party lines.

Next hearing set for 6 February 2025.

• Potential major influence on FDA policy and MedTech landscape.

7 January – MDCG 2023-3 Rev 2: Vigilance Guidance Updated

• Clarifies:

• Difference between incidents and serious incidents

• Use error vs abnormal use

• Undesirable side-effects reporting

10 January – MDCG 2024-7 & 2024-8 Updated

• PAR templates and NB designation forms updated.

• Redundant Section G.4 removed.

10 January – Mandatory Supply Interruption Reporting Begins

• Manufacturers now must report device interruptions under Regulation 2024/1860.

• Applies where interruption could pose serious public health risk.

12 January – EU HTA Regulation Becomes Applicable

• New EU framework for Health Technology Assessment (HTA).

• Applies first to high-risk medicinal products, Class III devices to follow in 2026.

• Aims for faster, wider access to innovation via joint clinical assessments.

14 January – EU Confirms Discrimination Against MDs in China

• Investigation finds China discriminates against EU device suppliers.

• EU to respond with International Procurement Instrument (IPI) measures.

21 January – European Health Data Space (EHDS) Regulation Adopted

• Aims for secure, interoperable EU-wide health data sharing.

• Implications for medical devices:

• Devices interoperable with EHRs must meet EHDS criteria

• Cross-border usability and data transparency required

• Will impact post-market monitoring and product documentation