The medical device regulatory landscape has experienced a wave of structural change since 2021 that shows no sign of slowing. The EU's shift from directives to full regulations under the MDR and IVDR, the UK's post-Brexit regulatory realignment, the FDA's alignment of its quality system requirements with ISO 13485, and China's overhaul of its NMPA approval process have each independently raised the bar for market access. What follows is a working guide to the active requirements and the material changes manufacturers must track in each major jurisdiction.
For manufacturers seeking access to multiple markets simultaneously, the challenge is no longer simply meeting each set of requirements in isolation. Compliance timelines in the EU, UK, US, and China are now running in parallel — and in some cases interacting. A QMS transition required for the US FDA may affect documentation that is simultaneously under review for an EU Notified Body. An EU Authorised Representative appointment required for EUDAMED registration also affects whether a CE-marked device can enter the UK market under the current recognition framework.
European Union — EU MDR, EUDAMED, and IVDR
EU MDR 2017/745 — Transition Deadlines Under Regulation (EU) 2023/607
Regulation (EU) 2017/745 (the EU Medical Device Regulation) has been fully applicable since 26 May 2021, replacing both the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). However, Regulation (EU) 2023/607 introduced extended transitional arrangements for devices that were lawfully on the market under MDD or AIMDD certificates that had not yet been transitioned to MDR conformity. Under these arrangements, Class III devices and Class IIb implantable devices must be covered by an MDR certificate by 31 December 2027. Class IIb (non-implantable), Class IIa, and Class I devices requiring Notified Body involvement must follow by 31 December 2028. These deadlines apply provided the manufacturer had a valid MDD/AIMDD certificate on 26 May 2021, has not made substantial changes to device design or intended purpose, and the device continues to not present an unacceptable risk to patient safety. Manufacturers who have not begun the transition process should be aware that Notified Body capacity is a real constraint — the number of EU-recognised Notified Bodies has contracted significantly since the start of the MDR transition.
EUDAMED — Commission Decision (EU) 2025/2371
Commission Decision (EU) 2025/2371 established that EUDAMED — the European Database on Medical Devices — becomes mandatory for registration of EU Authorised Representatives, manufacturers, and devices from 28 May 2026. The UDI module and device registration module are the first to become compulsory at that date. Devices already on the EU market at 28 May 2026 have until 28 November 2026 to complete EUDAMED registration. Non-EU manufacturers are required under Article 13 of the MDR to appoint a single EU Authorised Representative, and that representative's details — including their EUDAMED Single Registration Number (SRN) — must appear on the device label and in all registration records. Failure to be registered in EUDAMED by the applicable deadline will constitute non-compliance with the MDR, regardless of whether the device itself holds a valid CE certificate. Market surveillance authorities across EU member states are expected to use EUDAMED registration status as a primary enforcement check at the point of import.
EU IVDR 2017/746 — Extended Transitional Periods Under Regulation (EU) 2024/1860
Regulation (EU) 2017/746 (the In Vitro Diagnostic Regulation) introduced a complete reclassification of IVDs, moving the majority of diagnostics into higher risk classes that now require Notified Body involvement for the first time. Regulation (EU) 2024/1860 extended the transitional period for legacy IVD Directive (IVDD 98/79/EC) devices, with new cut-off dates by risk class: Class D (highest risk, including blood screening and HIV diagnostics) must hold an IVDR certificate by December 2027; Class C (including HbA1c, PSA, and self-test products) by December 2028; Class B and Class A sterile devices by December 2029. Manufacturers of IVDs that were previously self-certified under the IVDD and that now fall into Class C or above are facing their first mandatory Notified Body conformity assessment — a process that can take 18 months or more depending on the complexity of the device and the current backlog at IVDR-designated Notified Bodies.
United Kingdom — MHRA Regulatory Framework and CE Recognition
UK MDR 2002 and Ongoing CE Marking Recognition
The UK Medical Devices Regulations 2002 (SI 2002/618) remain the primary legislative framework for medical devices in Great Britain. The MHRA has provided transitional routes that allow CE-marked devices — certified under EU MDR 2017/745 or EU IVDR 2017/746 — to continue to be placed on the Great Britain market until 30 June 2030 without a separate UK Conformity Assessment. Devices bearing a legacy CE mark under the MDD or AIMDD are accepted until 30 June 2028, or until the CE certificate expires, whichever is sooner. A UK Responsible Person (UKRP) — a legal entity established in Great Britain — is mandatory for all non-GB manufacturers placing devices on the GB market. The UKRP's name and address must appear on or with the device. MHRA guidance on the full requirements is maintained at GOV.UK.
MHRA Consultation on Indefinite CE Recognition
The MHRA launched a formal consultation on 16 February 2026 examining the case for indefinite recognition of CE-marked medical devices on the Great Britain market, beyond the current 2030 deadline. The consultation reflects the practical reality that many manufacturers — particularly those outside the EU and UK — hold CE certificates as their primary route to GB market access and would face significant additional costs if required to pursue a separate UK conformity assessment pathway. Stakeholders were invited to submit responses by the close of the consultation period. Manufacturers supplying the GB market should monitor the outcome of this consultation, as it will determine whether the current CE recognition framework is extended or replaced with a distinct UK conformity route. Northern Ireland continues to follow EU product rules under the Windsor Framework and is not affected by these transitional arrangements.
UK Post-Market Surveillance Amendment Regulations 2025
Amendments to the UK MDR 2002 relating to post-market surveillance (PMS) obligations came into force in June 2025. The amendments strengthened requirements for systematic collection and review of post-market data, including Periodic Safety Update Reports (PSURs) for higher-risk devices and post-market clinical follow-up (PMCF) for implantables. These requirements align the UK framework more closely with the PMS obligations introduced under EU MDR 2017/745, reducing — but not eliminating — the regulatory divergence between the two regimes. Manufacturers supplying both EU and UK markets will find that a robust MDR-compliant PMS system provides a strong foundation for UK compliance, though the specific reporting timelines and formats may differ. MHRA has published updated guidance on its regulatory guidance pages.
United States — FDA QMSR and Premarket Pathways
FDA Quality Management System Regulation (QMSR) — Revised 21 CFR Part 820
The FDA Quality Management System Regulation (QMSR), which became effective on 2 February 2026, replaces the previous Quality System Regulation (QSR) under 21 CFR Part 820 with a framework that incorporates ISO 13485:2016 by reference. This is the most significant change to FDA device quality requirements in decades. Under the QMSR, manufacturers must comply with the requirements of ISO 13485:2016 as incorporated into the regulation, along with additional FDA-specific requirements on complaint files, corrective and preventive action (CAPA), and unique device identification (UDI). Manufacturers who had implemented QMS systems against the legacy 21 CFR Part 820 — which predated ISO 13485 — will need to conduct a gap assessment and update their documented systems, procedures, and records accordingly. The QMSR final rule was published in the Federal Register on 2 February 2024, providing a two-year transition period. All FDA-registered establishments must now be operating under a QMSR-compliant system.
FDA Premarket Pathways — 510(k), PMA, and De Novo
The three main pathways for device market authorisation in the US remain the Premarket Notification (510(k)) for Class II devices demonstrating substantial equivalence to a predicate device, the Premarket Approval (PMA) for Class III devices requiring clinical evidence of safety and effectiveness, and the De Novo Classification Request for novel devices of low to moderate risk that lack a valid predicate. Class I devices (approximately 47% of all device types) are generally exempt from premarket review, though they remain subject to general controls including establishment registration under 21 CFR Part 807 and device listing. The FDA clears approximately 3,000 devices per year through the 510(k) pathway. All establishments manufacturing, distributing, or re-labelling devices for the US market must be registered with the FDA annually. The QMSR requirement applies to all device classes above Class I exempt.
China — NMPA Order 739 and the Single Agent Requirement
NMPA Order 739 — Imported Medical Device Registration Requirements
NMPA Order 739, the Regulations for the Supervision and Administration of Medical Devices, came into force on 1 June 2021 and establishes the current framework for imported device registration in China. All imported medical devices — regardless of risk class — must be registered with the National Medical Products Administration (NMPA) at the national level. China applies a three-class risk classification system (Class I, II, III), and all imported devices are subject to national-level NMPA registration irrespective of class. This is a significant distinction from the EU system, where Class I devices may be self-certified. The Centre for Medical Device Evaluation (CMDE) conducts technical evaluation of registration dossiers. Certificates are valid for five years and must be renewed before expiry. China's UDI system is being phased in, with Class III devices required to carry a UDI since 2021, and lower-class devices following on a rolling schedule.
China Single Agent Requirement for Imported Devices
Non-Chinese manufacturers must appoint a single China agent — a legal entity established in China — who acts as the local responsible party for the registered device. This requirement is distinct from the EU Authorised Representative model in one important respect: the China agent's name must appear on the NMPA registration certificate itself, and on all device labelling. Changing the China agent requires amending the registration certificate — a process that takes significant time and resources and cannot be done on short notice. This creates a structural dependency between the manufacturer and their China agent that requires careful commercial and legal due diligence before appointment. The NMPA official portal and NMPA agent guidance set out the specific obligations. Manufacturers should ensure their China agent agreement addresses the obligations associated with post-market surveillance reporting, adverse event handling, and registration renewal in China.
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