There have been a number of recent regulatory developments affecting medical devices and in vitro diagnostic devices in the EU, building on the European Commission’s proposal to simplify the medical devices regime published at the end of 2025, and in the UK. These developments include procedural requirements for notified bodies’ conformity assessment activities under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), political agreement on amendments to the EU Artificial Intelligence Act, and significant reforms to the UK medical devices regime.
We set out below a summary of these updates and their implications for industry. Overall, these changes demonstrate regulatory pragmatism: the EU is seeking to make MDR/IVDR conformity assessment procedures and interactions with notified bodies more predictable, while the UK is updating its legislation in line with international standards to avoid market disruption and ease access to the market in Great Britain (GB).
These amendments will be welcomed by those companies grappling with compliance with the MDR/IVDR in the EU and who face parallel requirements when seeking to launch in the UK.
European Commission Implementing Regulation Introduces Rules for Notified Body Conformity Assessment Activities
On 4 May, the European Commission adopted Implementing Regulation 2026/977, establishing uniform and detailed procedural requirements for notified body conformity assessment activities under the MDR and IVDR. These changes respond to longstanding industry concerns about MDR/IVDR bottlenecks, inconsistent notified body practices, cost uncertainty, and delays.
The new rules seek to make conformity assessment more predictable and commercially manageable by setting out standardised timelines for assessment as well as provisions on providing quotes and notifications about changes to costs estimates.
Headline changes include:
- Minimum information to be submitted by the manufacturer before the notified body issues a quotation on (1) overall costs for the assessment of the quality management system (QMS) and technical documentation, (2) potential extra costs arising during the assessment, and (3) estimated timelines.
- Requirement to conduct conformity assessment activities according to the following maximum timelines: 30 days for application review, 120 days for QMS audits, 90 days for product verification, and 20 days for certification. There are also timelines for planned substantial changes. The Implementing Regulation permits “clock-stops” to allow the legal manufacturer to respond to requests for information.
- Requirement for notified bodies to notify manufacturers in advance if costs are projected to rise by more than 10%, providing justifications for such increases.
- Standardised process and timelines for recertification of product and QMS certificates.
In terms of application, the new quotation and timeline rules will not apply to contracts signed before 25 February 2027 and the recertification rules will not apply to certificates expiring before 25 November 2027.
For manufacturers who have experienced inconsistent costs, opaque timelines, or difficult recertifications, these rules will be welcomed. However, notified bodies have raised concerns about resourcing and the ability to meet these provisions, and industry will be closely watching whether these timelines are met.
EU AI Act Amendment
The European Parliament and Council have agreed AI Act simplification measures as part of the EU AI Act Omnibus package. Most significantly for medtech companies, the changes include:
- AI systems covered by MDR/IVDR now have until 2 August 2028 to meet high-risk obligations.
- Unfortunately, unlike machinery, medical devices and IVDs did not secure a carveout from parallel compliance obligations; as a result, AI-enabled medical devices continue to face overlapping regulatory regimes under both the AI Act and MDR/IVDR. The practical details will be set out in the full text when published, together with implementing acts and guidance.
While the extra time to meet the obligations under the AI Act will assist manufacturers, some may find disappointing the fact that dual compliance is still a reality. It is expected that AI-related requirements will be included in the MDR/IVDR or in associated implementing acts or guidance as part of the ongoing reforms to the legislation, so in practice these changes could have significant implications for companies.
Draft UK Devices Legislation Published
The UK has published its long-awaited draft amendments to the Medical Devices Regulations 2002, proposing the most significant overhaul of GB’s pre-market device framework in years. The draft Medical Devices (Amendment) Regulations 2026 have been published with a call for evidence on the proposed changes.
The Regulations set out a new standalone regulatory framework for GB and follow previous amendments made to the 2002 Regulations in June 2025 covering post-market surveillance requirements. The deadline for comments is 19 June, with proposed adoption expected in December 2026.
The changes will be familiar to companies as the new legislation seeks to align the GB system with the EU MDR/IVDR as well as international frameworks such as the International Medical Device Regulators Forum. Key changes include a risk-proportionate classification scheme, enhanced safety and performance requirements, stronger technical documentation requirements, mandatory Unique Device Identifiers, implant cards for implantables, and controls on misleading or unsubstantiated claims.
Most notably, the draft Regulations set out an international reliance pathway whereby UK approved bodies (known as notified bodies in the EU) are able to rely on assessments conducted by a “comparable regulator country” (Australia, Canada, the United States) to support GB market access. There are various options depending on the risk classification of the device and the assessment conducted by the comparable regulator. There are also GB-specific requirements that must be met before the product can be placed on the market in GB. This proposal has been well received by industry as a practical route to market for products that have already been assessed in another country.
Linked to this, the Medicines and Healthcare products Regulatory Agency published a consultation in February on indefinite recognition of EU CE marks for medical devices and IVDs. While this option was initially part of the international reliance routes to be included in the new legislation, given responses to the initial consultation it has since been removed and may be introduced separately.
The consultation closed in April 2026, although a response has yet to be published. As around 90% of medical devices currently used in GB are EU CE marked, the proposals for indefinite recognition would ensure consistent long-term supply to support the health system.