Our MedTech news for May 2026 covers the new implementing rules from the EU Commission, MedTech Europe’s call for regulatory coherence for AI-enabled devices, Team NB’s position on non-clinical data justification, and the draft Medical Devices (Amendment) Regulations 2026 from the MHRA.
The latest on the FDA’s Adverse Event Monitoring System and its final guidance on patient-matched guides for orthopaedic implants also feature, as well as five new clinical evaluation guidelines from China’s NMPA. Read on for more…
MedTech news from the EU & UK
New implementing rules for conformity assessment under MDR
On 4 May, the EU Commission published new implementing rules for conformity assessment activities carried out by notified bodies under the MDR.
Aiming to foster greater harmonisation, predictability, and efficiency across the EU regulatory framework, Implementing Regulation (EU) 2026/977 specifies certain uniform requirements for conformity assessment activities carried out by notified bodies designated under the MDR.
Requirements include quotations to manufacturers, maximum timeliness and “clock-stops” for key stages, establishment of monitoring systems for activity duration and cost – and publishing the information annually, as well as clarification on procedures and timelines for re-certification activities.
The Implementing Regulation will apply from 25 February 2027 onwards, except for the annual report on timelines and costs of conformity assessment activities which will apply from 1 January 2028. Read the regulation here.
MedTech Europe urges regulatory coherence for AI-enabled devices
On 7 May, EU co-legislators reached a political agreement on the Digital Omnibus, amending the AI Act. Contrary to the outcome MedTech Europe sought, this deal confirms that medical technologies will remain subject to the AI Act’s high-risk requirements.
MedTech Europe is advocating for a single, sector-specific compliance pathway, whereby high-risk AI requirements for medical technologies are implemented through the existing MDR and IVDR, rather than through parallel obligations under both frameworks.
With this latest outcome, the undergoing targeted revision of the MDR and IVDR now becomes the critical vehicle for addressing the concerns that were not resolved in the Digital Omnibus. Read more from MedTech Europe on this here.
Team NB shares position on non-clinical data justification
At the end of last month, Team-NB members adopted a paper outlining the approach taken by notified bodies when considering the acceptability of a manufacturer’s justification for relying on non-clinical data to demonstrate device safety and performance. The paper provides guidance on best practice for preparing a robust justification for its use. Read the full paper here.
MHRA publishes draft Statutory Instrument for future medical device regulatory framework
On 8 May, the MHRA published the draft Medical Devices (Amendment) Regulations 2026 on the World Trade Organization portal.
The framework overhauls Great Britain’s pre-market requirements, introducing an international reliance pathway, Unique Device Identifiers (UDI), patient implant cards, and risk-proportionate product classifications, as well as strengthened requirements for custom-made devices, SaMD, and IVD devices.
The draft Statutory Instrument brings the British medical device regulations into closer alignment with the EU MDR/IVDR and international standards, with key components supporting faster market access, enhanced traceability, and improved patient safety.
Find out more here and submit your views on the impact of the proposed changes via this MHRA survey.
MedTech news from the US & China
FDA’s MAUDE now replaced with AEMS
As of the end of this month, the FDA officially replaced the Manufacturer and User Facility Device Experience (MAUDE) database with its centralised Adverse Event Monitoring System (AEMS).
AEMS unifies seven fragmented legacy safety databases – including MAUDE (medical devices), FAERS (drugs), VAERS (vaccines), and AERS (veterinary products) – into a single, publicly searchable dashboard. The unified platform is designed to provide real-time, continuous surveillance of adverse events across all FDA-regulated products, rather than relying on periodic updates from the previous stand-alone systems.
Following the AEMS launch in March this year, the transition of medical device reports and the complete phase-out of MAUDE was finalised this month. Find out more about AEMS here.
FDA publishes final guidance on patient-matched guides for orthopaedic implants
On 6 May, the FDA released its final guidance on premarket submissions for patient-matched guides for orthopaedic implants.
Reflecting current review practices, the recommendations in the guidance are intended to promote consistency and facilitate efficient submission review. The document also provides considerations for manufacturers regarding design process development for these device types. Read the final guidance here.
NMPA publishes new clinical guidelines for Class III devices
On 30 April, China’s NMPA published five final guidelines to clarify clinical evaluation requirements for Class III medical devices.
The guidelines span clinical evaluation for spring coils systems through same-type comparison and single-use hemodialyzers respectively, as well as clinical trials for inferior vena cava filters, coronary modified balloons, and intracranial thrombectomy stents.
Overseas manufacturers may face demands for supplementary clinical trials or extensive retrospective data analysis during registration or renewal if their global clinical data deviates from these new Chinese criteria for effectiveness endpoints. Read more on the guidelines here.
That concludes our May 2026 MedTech news roundup. We’ll be back in June with more medical device news and updates.
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