Medical device compliance planning is complicated by the fact that the major regulatory frameworks — the EU MDR, EU IVDR, UK MHRA framework, FDA quality system requirements, and the Chinese NMPA registration regime — are not standing still. All four have material changes either recently in force or approaching within the next three years. Managing compliance in this environment requires a multi-market planning horizon, not a series of isolated national checklists.
This article organises those deadlines by jurisdiction and by status — what has already taken effect, what is imminent, and what requires long-range preparation. Manufacturers who are only now beginning to address the EU MDR transition, for example, will find that the available Notified Body capacity is a significant practical constraint on meeting the 2027 and 2028 cut-off dates. Early action is no longer optional in that context — it is a logistical requirement.
European Union — EU MDR and EUDAMED
EU Medical Device Regulation (EU) 2017/745 — In Force
Regulation (EU) 2017/745 became fully applicable on 26 May 2021. From that date, any new device placed on the EU market for the first time requires MDR conformity. Devices already on the market under valid MDD or AIMDD certificates were granted transitional periods (subsequently extended by Regulation (EU) 2023/607) to allow existing certificates to run to their new cut-off dates. Manufacturers must also ensure their Authorised Representative is formally designated and registered — this obligation under Article 11 and Article 13 of the MDR has been active since the MDR's date of application.
28 May 2026: EUDAMED Becomes Mandatory for Device Registration
Commission Decision (EU) 2025/2371 established 28 May 2026 as the date from which the UDI module and device registration module of EUDAMED become mandatory. All EU Authorised Representatives, manufacturers, and devices must be registered in EUDAMED by that date. Devices already on the market at 28 May 2026 have until 28 November 2026 to complete their EUDAMED registration. The EU AR's EUDAMED Single Registration Number (SRN) must appear on device labels. Manufacturers who have not yet initiated EUDAMED registration with their EU Authorised Representative should treat this as an immediate action item — registration requires preparation time, and the EU AR must be in place before the device registration can be completed.
31 December 2027: MDR Certificate Required for Class III and Class IIb Implantable Devices
Under Regulation (EU) 2023/607, manufacturers of Class III devices and Class IIb implantable devices that were placed on the market under legacy MDD or AIMDD certificates must hold an MDR-issued certificate by 31 December 2027. After this date, these devices may no longer be placed on the EU market or put into service without MDR certification. Given that the Notified Body assessment process for complex Class III devices can take between 18 and 36 months, manufacturers in this category who have not already submitted their MDR application to a Notified Body are facing a very compressed timeline. The cut-off applies regardless of when the original MDD certificate was issued or when it expires.
31 December 2028: MDR Certificate Required for Class IIb (other), Class IIa, and Class I with NB
Class IIb devices that are not implantable, Class IIa devices, and Class I devices requiring Notified Body involvement (sterile or measuring function) must be covered by an MDR certificate by 31 December 2028. The same conditions apply as for the 2027 deadline: the device must have been lawfully on the market under a valid MDD certificate on 26 May 2021, and there must have been no substantial changes to device design or intended purpose. Notified Body capacity for Class IIa and IIb devices is under significant pressure — manufacturers should not assume that capacity will be freely available in 2027 or 2028 simply because the cut-off date is later.
European Union — EU IVDR
December 2027: IVDR Certificate Required for Class D IVDs
Regulation (EU) 2017/746 (the IVDR) applies a four-class risk classification to in vitro diagnostic devices. Class D devices — those carrying the highest patient risk, including blood screening assays, HIV diagnostics, and NAT tests — must hold an IVDR certificate from a Notified Body by December 2027. These devices were previously subject to national or self-certification pathways under the legacy IVDD. The IVDR Notified Body landscape is currently limited, and the available bodies have long assessment queues. The IVDR transitional regulation (EU) 2024/1860 confirmed these extended deadlines but did not change the substantive IVDR requirements themselves.
December 2028: IVDR Certificate Required for Class C IVDs
Class C IVDs — including HbA1c tests, PSA assays, self-test products, and companion diagnostics — must be IVDR certified by December 2028. This class contains a large proportion of IVDs that were previously self-certified under the IVDD and now require mandatory Notified Body conformity assessment for the first time. Manufacturers in this category face the dual challenge of assembling a full MDR/IVDR-style technical file while simultaneously engaging with a limited pool of IVDR-designated Notified Bodies. Clinical performance evaluation and post-market performance follow-up (PMPF) plans are required elements of the Class C submission dossier.
December 2029: IVDR Requirements for Class B and Class A Sterile IVDs
Class B IVDs (including most general laboratory reagents) and Class A sterile IVDs must be IVDR certified by December 2029. Class A non-sterile IVDs — the lowest-risk category — are self-certified under the IVDR and have no Notified Body involvement requirement, though they must still meet all applicable general safety and performance requirements and carry CE marking. Manufacturers in the Class B and A-sterile categories should begin their IVDR readiness assessments now to allow time for technical file preparation and Notified Body engagement before the 2029 deadline.
United Kingdom
UK CE Marking Recognition Window — Until 30 June 2030
The MHRA currently accepts CE-marked devices under EU MDR 2017/745 or EU IVDR 2017/746 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. A UK Responsible Person must be appointed for all non-GB manufacturers, with name and address on the device or accompanying documentation. Full requirements are maintained by MHRA guidance. Manufacturers should monitor whether the MHRA's February 2026 consultation on indefinite CE recognition results in an extension of the 2030 deadline or a transition to a new UK-only route.
June 2025: UK Post-Market Surveillance Amendment Regulations in Force
Amendments to the UK MDR 2002 strengthening post-market surveillance requirements — including Periodic Safety Update Reports (PSURs) and Post-Market Clinical Follow-Up (PMCF) obligations — came into force in June 2025. These obligations now apply to devices already on the GB market. Manufacturers supplying the GB market who had not previously implemented a structured PMS programme should conduct a gap assessment against the updated requirements. The amendments broadly align the UK PMS framework with EU MDR obligations, reducing divergence between the two systems for manufacturers supplying both markets.
United States
2 February 2026: FDA Quality Management System Regulation (QMSR) Now in Force
The revised FDA Quality Management System Regulation (QMSR) under 21 CFR Part 820, which incorporates ISO 13485:2016 by reference, became mandatory on 2 February 2026. All FDA-registered establishments — manufacturers, contract manufacturers, and specification developers — must now operate under a QMSR-compliant quality system. The previous two-year transition period that followed the rule's publication on 2 February 2024 has ended. Manufacturers who have not yet completed their QMS transition from the legacy 21 CFR Part 820 format are now operating out of compliance. FDA inspections from this date are expected to assess QMSR conformance directly, including the ISO 13485 management review, supplier control, and CAPA elements that were not previously explicit in the QSR.
Annual FDA Establishment Registration and Device Listing
All establishments involved in the manufacture, distribution, or relabelling of devices for the US market must register annually with the FDA under 21 CFR Part 807. Registration renewal occurs each year during the period 1 October through 31 December, with the new registration year running from 1 January through 31 December. Device listings must be updated within 30 days of any change in devices manufactured, distributed, or discontinued. Foreign establishments must also have a US Agent registered with the FDA. Failure to maintain a current establishment registration and device listing is a prohibited act under 21 USC 331 and can result in import alerts and enforcement action.
China
NMPA Registration Renewal — All Imported Device Classes
NMPA medical device registration certificates under Order 739 are valid for five years from the date of issue. Registration renewal applications must be submitted to the NMPA before the certificate expires — late submission risks a lapse in registration that would require a full re-registration. All imported devices, regardless of risk class, require national-level NMPA registration. The China agent whose name appears on the certificate must remain in place throughout the certificate lifecycle; any change to the China agent requires a certificate amendment before it takes effect. Manufacturers with certificates approaching their five-year anniversary should initiate renewal planning at least 12 months in advance given the CMDE review timelines and the documentation requirements involved.
China UDI Phase-In — Class III Already Mandatory; Lower Classes Following
China's UDI system has been mandatory for Class III imported medical devices since 2021. The phased implementation for Class II and Class I devices continues on a rolling schedule set by the NMPA. Manufacturers who have already implemented UDI for EU MDR or FDA purposes will find significant overlap in the data elements required, though China's UDI system uses a separate national coding system under the NMPA's Data Repository. Manufacturers should verify current UDI obligations for their specific device class and category against the latest NMPA implementation schedule, available on the NMPA official portal.
Planning Across Markets
A multi-market compliance calendar for medical devices in 2026–2029 must account for more than just the individual deadlines. The EUDAMED registration process depends on the EU Authorised Representative being in place and registered — which in turn affects whether a CE-marked device can be recognised in the UK. A QMSR gap assessment in the US may surface documentation changes that also need to be reflected in the Technical Documentation submitted to the EU Notified Body. Renewal of an NMPA certificate in China may require updated labelling reflecting the current China agent — which must align with the labelling filed with other authorities.
The practical implication is that compliance planning for devices sold across the EU, UK, US, and China must be coordinated across all four markets simultaneously. Deadline-by-deadline, single-market planning increases the risk of costly retroactive corrections.
Need help building a multi-market medical device compliance calendar?
TGC supports manufacturers with EU MDR/IVDR Notified Body preparation, EUDAMED registration, QMSR gap assessments, and NMPA renewal — coordinated across all four markets.