EU MDR 2017/745, US FDA 510(k) and PMA, UK MHRA registration, and China NMPA Order 739 each impose distinct classification, conformity assessment, quality system, and post-market requirements. TGC's specialist medical device compliance team delivers EU Authorised Representative services, technical documentation support, EUDAMED registration, FDA submission support, China local agent representation, and multi-market device regulatory programmes for manufacturers, importers, and distributors at every stage of market access.
types of medical devices and IVDs
currently on the EU
market, each now
subject to EU MDR or IVDR requirements
Source: European Commission, Medical Devices Sector Overview
Medical devices occupy one of the most tightly regulated product sectors in global trade. The EU, UK, US, and China each maintain independent conformity assessment frameworks with distinct classification systems, pre-market pathway requirements, quality management standards, and post-market surveillance obligations - and none of them directly recognises the others.
In the EU, EU MDR 2017/745 has been fully applicable since 26 May 2021, requiring all non-EU manufacturers to appoint an EU Authorised Representative under Article 13, and imposing significantly stricter Notified Body oversight, technical documentation, and post-market surveillance requirements than the MDD it replaced. Legacy devices operating under transitional provisions face hard deadlines of 31 December 2027 (Class III and IIb implantables) and 31 December 2028 (Class IIb other, IIa, and Class I with Notified Body involvement) under Regulation (EU) 2023/607. In parallel, EUDAMED becomes mandatory from 28 May 2026.
In the US, the FDA cleared approximately 3,000 devices per year via the 510(k) pathway, while the Quality Management System Regulation (QMSR) - which revised 21 CFR Part 820 to incorporate ISO 13485:2016 by reference - became effective 2 February 2026, replacing the legacy Quality System Regulation inspection framework. In the UK, CE marking for MDR/IVDR-compliant devices remains valid until 30 June 2030 under current MHRA transitional arrangements, with the MHRA consulting on indefinite recognition as of February 2026. In China, all imported devices require national NMPA registration under State Council Order 739, with a mandatory local agent requirement.
TGC provides specialist medical device compliance support for manufacturers, importers, and distributors operating across multiple markets. We combine deep regulatory expertise with practical device experience - covering EU Authorised Representative provision, CE marking documentation and Notified Body coordination, EUDAMED registration, FDA 510(k) submission support, UK Responsible Person services, China NMPA local agent representation, and ongoing multi-market post-market surveillance programme management.
From the EU's tightened MDR requirements and approaching EUDAMED deadline to the US FDA's new QMSR quality system rules, the UK's extended CE marking arrangements, and China's national NMPA registration obligation, medical device regulation is undergoing active change in every major market simultaneously.
Commission Decision (EU) 2025/2371, adopted 26 November 2025, sets 28 May 2026 as the mandatory start date for EUDAMED's UDI and device registration module. From this date, all new medical devices must be registered in EUDAMED with a valid UDI before EU market placement. EU Authorised Representatives are responsible for EUDAMED registration on behalf of non-EU manufacturers.
On 16 February 2026, the MHRA launched a consultation proposing to recognise CE-marked medical devices indefinitely in Great Britain, removing the 2028 and 2030 sunset deadlines currently in place. If confirmed, this would align Great Britain's medical device market access route permanently with EU MDR and IVDR conformity. Source: UK Government, MHRA Consultation, February 2026.
The FDA's final rule revising 21 CFR Part 820 became effective 2 February 2026. The QMSR incorporates ISO 13485:2016 by reference, harmonising US quality system requirements with the international standard. All registered device manufacturers must operate an ISO 13485:2016-aligned QMS, and FDA inspectors now reference ISO 13485 requirements directly. Source: Federal Register, QMSR Final Rule.
All foreign manufacturers importing medical devices into China must appoint a single designated China agent. The agent's name, address, and contact details appear on the NMPA registration certificate and must be included on all product labelling. The agent is responsible for regulatory communications, post-market surveillance, and certificate renewal. Each imported device registration may list only one China agent — careful planning is essential in multi-distributor supply chains. Source: NMPA, Medical Device Registration Provisions 2024.
Medical device compliance in 2025–2026 is defined by a convergence of live deadlines that affect both legacy devices and new market entrants. These are the requirements that need to be on every device manufacturer's compliance roadmap today.
types of medical devices on the EU market — all now subject to EU MDR or IVDR requirements, with Notified Body oversight mandatory for classes IIa and above
independent regulatory regimes — EU, UK, US, China — each with separate conformity assessment, representative obligations, quality system requirements, and post-market surveillance frameworks
EU Authorised Representative under MDR Article 13 for every non-EU manufacturer — no exemptions, no grace periods, with joint liability between the AR and the manufacturer
A structured overview of the core regulatory obligations across the four largest target markets — covering classification, pre-market pathways, quality systems, and representative requirements.
| Requirement | EU | UK (Great Britain) | US (FDA) | China (NMPA) |
|---|---|---|---|---|
| Device classification | 4 classes: I, IIa, IIb, III (MDR); 4 classes: A, B, C, D (IVDR). 22 classification rules in MDR Annex VIII | Equivalent to EU MDR/IVDR classification for transitional CE-marked devices. MHRA registers all classes | 3 classes: 1 (general controls), 2 (special controls, typically 510(k)), 3 (PMA). ~47% Class 1, 43% Class 2, 10% Class 3 | 3 classes: I (low risk), II (medium risk), III (high risk). All imported devices require national NMPA registration regardless of class |
| Pre-market pathway | Class I: manufacturer self-certification (except sterile/measuring). Class IIa, IIb, III: Notified Body conformity assessment + CE marking | CE marking (EU MDR/IVDR compliant) accepted until 2030 (2028 for legacy MDD/AIMDD). MHRA registration required for all classes | Class I: general controls, mostly exempt from 510(k). Class II: 510(k) premarket notification. Class III: PMA (clinical data required). Novel low/moderate risk: De Novo | All imported devices: national NMPA registration regardless of class. Technical review by CMDE. Clinical evaluation required for Class II and III |
| Quality management | ISO 13485:2016 required for Notified Body assessment. Post-market surveillance plan, PSUR/PMCF obligations under MDR | ISO 13485:2016 or equivalent. GB PMS amendment (June 2025) requires mandatory PMS plans and PSURs | 21 CFR Part 820 QMSR (effective 2 February 2026), incorporating ISO 13485:2016 by reference. FDA facility inspection before PMA approval | ISO 13485 (YY/T 0287 equivalent) required. GB and YY technical standards apply. NMPA-designated laboratory testing required |
| Representative / agent | EU Authorised Representative mandatory for all non-EU manufacturers (MDR Article 13). Must be registered in EUDAMED. Joint liability with manufacturer | UK Responsible Person mandatory for all non-UK manufacturers (SI 2002/618 as amended). Must be established in UK | US agent required for foreign establishments (21 CFR 807.40). Annual FDA establishment registration required | Single China agent mandatory for all foreign manufacturers. Agent name on certificate and all labelling. One agent per registered product |
Our medical device compliance work spans the full product lifecycle - from pre-submission regulatory strategy and classification advice through EU Authorised Representative provision, EUDAMED registration, 510(k) submission support, China NMPA local agent representation, and post-market surveillance programme management across multiple markets.
TGC provides EU Authorised Representative services for non-EU medical device and IVD manufacturers, fulfilling the mandatory MDR Article 13 and IVDR Article 11 requirements. We register as the named Authorised Representative in EUDAMED, hold the required technical documentation and EU declarations of conformity, act as the contact point for market surveillance authorities across all EU member states, and manage EUDAMED registration and UDI implementation. We assume joint liability with the manufacturer as required by the MDR/IVDR and ensure our manufacturer clients are supported in meeting their EU obligations throughout the certificate lifecycle.
For device manufacturers transitioning legacy MDD/AIMDD certificates to EU MDR compliance, or pursuing MDR CE marking for new products, TGC supports technical documentation preparation, clinical evaluation report development, Notified Body selection and audit coordination, and EU declaration of conformity drafting. We advise on device classification under the 22 MDR Annex VIII rules, identify the appropriate conformity assessment route, and manage the Notified Body engagement process from pre-submission through to certificate issue - including for manufacturers operating under the extended transitional deadlines of December 2027 or December 2028.
With EUDAMED's UDI and device module becoming mandatory on 28 May 2026 under Commission Decision (EU) 2025/2371, device manufacturers and their EU Authorised Representatives must be registered and operational well in advance of the deadline. TGC manages the complete EUDAMED registration process - from Authorised Representative and economic operator registration through to UDI-DI assignment, device module data population, and certificate/declaration registration. For manufacturers with large product portfolios, we provide structured UDI implementation support including EUDAMED data quality reviews to ensure all registrations are accurate and complete before the mandatory deadline.
For device manufacturers entering the US market, TGC supports 510(k) premarket notification strategy and submission preparation - including predicate device identification, substantial equivalence argumentation, performance testing protocol review, and 510(k) document assembly. We advise on De Novo classification requests where no suitable predicate exists. We also support QMSR compliance - the revised 21 CFR Part 820 that became effective 2 February 2026 and incorporates ISO 13485:2016 by reference - conducting gap assessments against the new standard, supporting QMS documentation updates, and advising on FDA inspection readiness under the updated compliance programme framework.
Non-UK medical device manufacturers must appoint a UK Responsible Person and register all devices with the MHRA before placing them on the Great Britain market. TGC provides UK Responsible Person services under the UK Medical Devices Regulations 2002, manages MHRA device registration across all device classes, and advises on the current CE marking acceptance arrangements - including the transitional deadlines of 30 June 2028 (legacy MDD/AIMDD) and 30 June 2030 (EU MDR/IVDR compliant) and the MHRA's consultation on indefinite CE recognition. We also support manufacturers in meeting the GB post-market surveillance requirements introduced under the June 2025 amendment.
For device manufacturers targeting the Chinese market, TGC provides China local agent representation under the NMPA framework - including registration dossier preparation and submission, technical documentation translation and adaptation to Chinese requirements, CMDE liaison during technical review, and post-registration maintenance including adverse event reporting, certificate renewals, and registration amendment management. We advise on clinical evaluation strategies for Class II and Class III devices, support ISO 13485 and GB/YY standard compliance, and manage the agent succession risk issue structurally so that our clients are not exposed to market access disruption if commercial relationships change.
These are the compliance situations we encounter most frequently when device manufacturers come to TGC — often following a market access disruption, a regulatory inquiry, or a failed product launch that a structured regulatory review would have prevented.
Non-compliance from day one
December 2027/2028 deadlines at risk
FDA submission failure or hold
Single-agent structural dependency
28 May 2026 deadline exposure
Siloed markets, compounding gaps
Answers to the questions we hear most often from medical device manufacturers, importers, and distributors navigating multi-market regulatory requirements.
Regulation (EU) 2017/745 became fully applicable on 26 May 2021, replacing the Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC. Under MDR Article 11 and Article 13, any manufacturer established outside the EU that places a device on the EU market must appoint a single EU Authorised Representative. The Authorised Representative is jointly liable with the manufacturer if the manufacturer has not fulfilled its MDR obligations, must be registered in EUDAMED, and must hold copies of all EU declarations of conformity and technical documentation.
Class IIa, IIb, and III devices require Notified Body conformity assessment. Class I non-sterile, non-measuring devices may be self-certified. The MDR imposes Unique Device Identification (UDI) requirements and EUDAMED registration obligations, with the UDI and device module becoming mandatory from 28 May 2026 under Commission Decision (EU) 2025/2371. Post-market surveillance obligations are significantly strengthened compared to the MDD, including mandatory periodic safety update reports (PSURs) and post-market clinical follow-up (PMCF) plans. Source: EUR-Lex, Regulation (EU) 2017/745.
Regulation (EU) 2023/607 extended the MDR Article 120 transitional provisions for legacy devices CE-marked under the MDD or AIMDD. To benefit, the device must not have undergone significant changes in design or intended purpose, and a signed written agreement with a Notified Body must be in place. The transition deadlines are: 31 December 2027 for Class III and Class IIb implantable devices; and 31 December 2028 for Class IIb (other than implantables), Class IIa, and Class I devices requiring Notified Body involvement. After the applicable deadline, a valid MDR Notified Body certificate is required for continued EU market access.
Separately, the IVDR transitional periods under Regulation (EU) 2024/1860 set compliance deadlines of December 2027 for Class D legacy IVDs, December 2028 for Class C, and December 2029 for Class B and Class A sterile IVDs. Manufacturers with large IVD portfolios subject to IVDR should already have Notified Body engagements underway for higher-risk classes. Source: EUR-Lex, Regulation (EU) 2023/607.
Most Class II medical devices require a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The 510(k) pathway was established by the Medical Device Amendments of 1976 and requires the submitter to show that the device has the same intended use and equivalent - or different but not raising new safety questions about - technological characteristics. The FDA clears approximately 3,000 devices per year through this pathway.
Class I devices (approximately 47% of all FDA-regulated devices) are generally exempt from premarket notification and subject only to general controls. Class III devices require Premarket Approval (PMA), involving clinical data, scientific review, and manufacturing facility inspection. Novel devices without a suitable predicate may pursue De Novo classification. All registered establishments must also comply with the QMSR (21 CFR Part 820), which became effective 2 February 2026 and incorporates ISO 13485:2016 by reference. Source: FDA, Classify Your Medical Device.
CE marking remains the primary route to the Great Britain medical device market through extended MHRA transitional arrangements. Devices CE-marked under the EU MDR or IVDR may be placed on the Great Britain market until 30 June 2030. Devices CE-marked under the legacy EU MDD or AIMDD may remain until the certificate expires or until 30 June 2028, whichever is earlier. All devices on the GB market must be registered with the MHRA, and non-UK manufacturers must appoint a UK Responsible Person. Source: MHRA, Regulating Medical Devices in the UK.
On 16 February 2026, the MHRA launched a consultation proposing to recognise CE-marked medical devices indefinitely in Great Britain - potentially removing the 2028 and 2030 deadlines entirely. The consultation runs until 10 April 2026. Northern Ireland continues to follow EU MDR and IVDR requirements under the Windsor Framework, meaning EU MDR CE marking is required for Northern Ireland market access regardless of the GB transitional position. Source: MHRA Consultation, February 2026.
China's medical device framework is governed by State Council Order 739, effective 1 June 2021. Devices are classified into three risk classes, but all imported medical devices - regardless of class - require national NMPA registration. Foreign manufacturers must appoint a single designated China agent, whose name and address appear on the NMPA registration certificate and on all product labelling and instructions for use. The agent manages regulatory communications, post-market surveillance reporting, and certificate renewal. Registration certificates are valid for five years.
Quality management systems must comply with ISO 13485 (reflected in YY/T 0287) and devices must be tested in NMPA-designated laboratories against applicable GB and YY technical standards. Clinical evaluation is required for all imported Class II and Class III devices. For Class III devices involving novel technology, locally conducted clinical trials may be required. The CMDE (Centre for Medical Device Evaluation) conducts technical reviews on behalf of the NMPA. Source: NMPA, Medical Device Registration and Filing Provisions 2024.
EUDAMED is the European Database on Medical Devices, comprising six modules covering UDI and device registration, economic operators, certificates and declarations of conformity, clinical investigations, vigilance, and market surveillance. Commission Decision (EU) 2025/2371, adopted 26 November 2025, set 28 May 2026 as the mandatory date for the first four modules - including the UDI and device module. From this date, all new medical devices placed on the EU market must be registered in EUDAMED with a valid UDI before market placement. Devices already on the market before 28 May 2026 have until 28 November 2026 to complete registration.
EU Authorised Representatives are responsible for EUDAMED registration on behalf of non-EU manufacturers. Registration requires a valid UDI-DI (Device Identifier) assigned by an FDA-accredited issuing agency (such as GS1, HIBCC, or ICCBBA). Manufacturers should begin UDI assignment and EUDAMED data preparation well in advance of the May 2026 deadline — particularly if they have large device portfolios requiring individual device registration. Source: European Commission, EUDAMED Overview.
EU · UK · US · China device specialists
Structured milestone tracking to hard regulatory dates
Four markets managed as one coordinated programme
Talk to a TGC specialist about your device, your target markets, and your deadlines. Whether you need an EU Authorised Representative, EUDAMED registration support, a 510(k) strategy, UK Responsible Person services, or China NMPA local agent representation - we will tell you exactly what is needed and deliver it.
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