MedTech Regulation in 2026
Three regulatory shifts now drive launch timing, acquisition value, and portfolio risk in MedTech.
A concise executive briefing prepared for General Counsels, regulatory leadership teams, and MedTech transaction stakeholders navigating MDR & IVDR, UK reform, and the AI Act through 2028.
Prepared following the EMEA Medical Device Roundtable hosted by Ropes & Gray on 7 May 2026.
Designed for internal forwarding across legal, regulatory, and corporate development teams.
On 7 May 2026, Ropes & Gray hosted the EMEA Medical Device Roundtable at The Grove, Hertfordshire. General Counsels from Smith & Nephew, Medtronic, Fresenius Kabi, Abbott, Intuitive Surgical, Convatec, Boston Scientific, BD and others convened to discuss how the regulatory shifts of the past two years are now affecting deals, product launches and portfolio strategy.
This briefing synthesises the keynote delivered to that group and is written for circulation within legal, regulatory, corporate development, and portfolio leadership teams.
Hosted by Ropes & Gray.
Briefing authored by Dr Alastair Selby, SciMed Consultancy Ltd.
1 |
EU MDR/IVDR transition reality
Where the staged transition under Regulation (EU) 2023/607 actually sits in 2026, what the Commission’s December 2025 targeted revision will and won’t change, and where the Notified Body capacity constraint is now the binding factor.
2 |
The UK as a discrete commercial choice
The UK Post-Market Surveillance Regulations have been in force since June 2025. The forthcoming International Recognition Framework will turn UK approval into a per-product decision rather than a single corporate route.
3 |
The AI Act as a second classification on SaMD
August 2027 is the operative date for high-risk obligations. Most clinical decision-support software is high-risk under both the MDR and the AI Act. What that means for change control, conformity assessment, and deal diligence.
Inside the Executive Briefing
A concise synthesis of the regulatory developments now influencing launch sequencing, portfolio exposure, diligence priorities, and AI-enabled product strategy across MedTech.
Your details remain confidential and will only be used by SciMed Consultancy Ltd to send the briefing and occasional relevant regulatory updates.
Inside the Briefing
The three regulatory shifts, in one synthesised argument
Eight diligence questions to add to standard MedTech M&A templates
A dated calendar of milestones through to end-2028
Citations to Reg (EU) 2023/607, the UK PMS Regs 2024, Reg (EU) 2024/1689, and MDR Annex VIII Rule 11
About the author
Dr Alastair Selby is Managing Consultant of SciMed Consultancy Ltd, a UK-based regulatory and clinical evaluation consultancy working with medical device manufacturers from start-ups through to multinationals. His practice covers EU MDR and IVDR compliance, UK MHRA requirements, clinical and performance evaluation, biological evaluation, risk management, and post-market surveillance across cardiovascular, IVD, software and digital health, combination products, regenerative medicine, and orthopaedics.
BSI Technical Committees CH/210 (quality management for medical devices) and CH/194 (biological and clinical evaluation) | BSI Working Group CH/194/WG4, contributing to ISO 18969 | MHRA Ventilator Taskforce (COVID-19) | All-Party Parliamentary Group on Access to Medicines and Medical Devices | PhD Biomedical Materials, University of Manchester
If your team needs to pressure-test the implications
The briefing is designed to frame the regulatory questions.
If you are assessing the impact of MDR transition exposure, UK route strategy, or AI Act obligations against a specific product, transaction, or portfolio decision, we can help evaluate the practical implications.
Focused, advisory-led discussions for legal, regulatory, and corporate teams.
