EU MDR 2017/745 replaced the Medical Device Directive in 2021 and fundamentally changed how medical devices reach the European market. This comprehensive guide covers classification, clinical evidence requirements, PMCF obligations, Notified Body submission, and every key update through 2026 — written for RA managers and C-suite decision-makers.
EU MDR 2017/745 is not static. The European Commission, MDCG, and Notified Bodies continue to issue guidance, clarifications, and regulatory updates that affect manufacturers with CE-marked devices or active transition programs. These are the most significant developments RA managers need to track in 2026.
Published in 2025, MDCG 2025-6 clarifies how EU MDR 2017/745 and the EU AI Act (Regulation 2024/1689) interact for AI-based medical devices (SaMD). For AI SaMD classified as high-risk under the AI Act, manufacturers must now address both the MDR conformity assessment pathway and the AI Act technical documentation requirements simultaneously. Notified Bodies are expected to assess AI Act compliance as part of the MDR QMS review for relevant devices.
The European Commission extended the transitional provisions for legacy MDD-certified devices via Regulation (EU) 2024/1860. Devices certified under MDD before the transition deadline may continue to be placed on the market until specific dates depending on device class — generally until December 2027 for higher-risk devices and December 2028 for lower-risk devices, provided certain conditions are met including Notified Body availability. Manufacturers must have an active EU MDR transition plan in place to benefit from these extensions.
EUDAMED (European Database on Medical Devices) continues to expand its mandatory functionality. UDI-DI registration is now required before device sale in the EU. Clinical investigation registration in EUDAMED — including SADE reporting and annual progress reports — is mandatory for all EU MDR clinical investigations. Manufacturers without active EUDAMED accounts and UDI management systems face registration compliance risk.
Notified Bodies across Europe — including TUV SUD, BSI, and SGS — have significantly increased scrutiny on PMCF Plan and PMCF Report quality during surveillance audits. Generic PMCF Plans without explicit CER data gap mapping are now generating routine non-conformities. Manufacturers should review their PMCF documentation against current NB expectations, which require each data gap to be assigned a specific PMCF activity with defined methodology, timeline, and success criteria.
The EMA-NB coordination procedure for drug-device combination products has become standard practice following several years of implementation. Manufacturers of Class III devices incorporating a drug component (Rule 13) should anticipate mandatory EMA or national medicines authority consultation during Notified Body conformity assessment — adding 3 to 6 months to the standard CE marking timeline.
EU MDR 2017/745 (Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices) is the current European regulatory framework governing the safety, performance, and CE marking of medical devices placed on the EU market. It entered into force on 26 May 2017 and became fully applicable on 26 May 2021, replacing the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).
EU MDR applies to all medical devices placed on the European Economic Area (EEA) market, regardless of the manufacturer's country of origin. A medical device is defined under Article 2(1) as an instrument, apparatus, appliance, software, implant, reagent, material, or other article intended to be used for humans for diagnostic, preventive, monitoring, therapeutic, or other medical purposes — whose principal intended action is not achieved by pharmacological, immunological, or metabolic means.
The regulation covers the full device lifecycle — from design and manufacture through CE marking, post-market surveillance, PMCF, and vigilance reporting. It also introduced specific requirements for economic operators (importers, distributors, and authorised representatives) who play a role in the supply chain.
EU MDR is enforced through a system of designated Notified Bodies (NBs) — private certification organisations accredited by national competent authorities (NCAs) to conduct conformity assessments. Unlike the FDA, there is no single European medicines or device agency with approval authority. CE marking is issued by the Notified Body, not by a governmental body.
The MDCG (Medical Device Coordination Group) — comprising representatives of EU Member States — issues guidance documents (MDCG guidances) to clarify EU MDR requirements. These are not legally binding but are applied as de facto standards by Notified Bodies during conformity assessments.
EU MDR uses a risk-based classification system defined in Annex VIII, applying 22 classification rules to determine device class. Classification determines the conformity assessment pathway, the level of Notified Body involvement, and the post-market obligations. Getting classification right before engaging a Notified Body is critical — misclassification is one of the most common and costly early regulatory errors.
Lowest risk. Most Class I devices require only a Declaration of Conformity — no Notified Body involvement. Class Is (sterile) and Class Im (measuring) require partial NB involvement.
Moderate risk. Notified Body involvement required for conformity assessment. Clinical evaluation report (CER) required. PMCF programme required under Annex XIV Part B.
Significant risk. Comprehensive NB review. More demanding clinical evidence requirements. Biennial PSUR reporting. Robust PMCF programme required with registry participation often expected.
Highest risk. Strictest requirements. Clinical investigation typically required (Article 61). Annual PSUR. SSCP published in EUDAMED. 10-year PMCF for AIMDs. EMA consultation for drug components.
The transition from MDD to EU MDR is not a simple recertification — it is a fundamental change in the clinical evidence standard and post-market obligations. Understanding what changed helps manufacturers prioritise their transition activities.
| Requirement | MDD 93/42/EEC | EU MDR 2017/745 |
|---|---|---|
| Clinical evidence standard | Literature review or substantial equivalence typically sufficient for most devices. Clinical investigations rarely required below Class III. | Systematic Clinical Evaluation (CER) per MDCG 2020-13 required for all classes. Active generation of clinical evidence expected. Higher bar for equivalence claims. |
| Equivalence claims | Relatively straightforward — manufacturers could claim equivalence to competitor devices without direct access to their data. | Strict equivalence criteria across technical, biological, and clinical dimensions. Class III/implantables: contractual access to competitor's technical file required for equivalence. |
| Post-market clinical obligations | Limited PMCF requirements. No mandatory PSUR. PMS was less prescriptive. | Mandatory PMCF under Annex XIV Part B. Annual/biennial PSUR for Class IIb/III. PMCF Plan and Report required with explicit gap-mapping from CER. |
| Notified Body involvement | Less rigorous scrutiny. Many NBs had limited medical expertise in specific device categories. | Restructured NB designation with minimum expert requirements per device category. Scrutiny procedures for Class III. EMA/NB coordination for combination products. |
| Post-market reporting | No PSUR requirement. PMCF Report only for devices where PMCF was conducted. | PSUR mandatory for Class IIb/III. SSCP required for Class III and implantables, published in EUDAMED. Annual CER update expected. |
| EUDAMED registration | National registration databases. No pan-European unified system. | Mandatory EUDAMED registration for all devices including UDI, clinical investigations, vigilance events, and SSCP publication. |
| Device reclassification | Lower risk classes for many borderline products (software, substance-based devices, reprocessed devices). | Many devices reclassified upward: SaMD typically Class IIa-III under Rule 11; substance-based devices Class IIa under Rule 21; reprocessed single-use Class IIb/III under Rule 22. |
These are the requirements that determine the volume and quality of work required for EU MDR compliance. Each links to the detailed Eclevar guide for that specific topic.
The CER is the cornerstone document of EU MDR compliance. It must demonstrate that the device achieves its intended purpose and that residual risks are acceptable relative to clinical benefits. The CER must follow MDCG 2020-13, include a pre-specified systematic literature review, and be updated annually. For Class III and implantable devices, the clinical evaluator must hold specific qualifications.
CER complete guidePMCF under Annex XIV Part B requires manufacturers to proactively collect post-market clinical data through surveys, investigations, registry participation, or literature monitoring. The PMCF Plan must explicitly map each unresolved data gap from the CER to a specific PMCF activity. PMCF findings feed into the annual CER update and the PSUR.
PMCF complete guideEU MDR requires manufacturers to implement a quality management system covering the full device lifecycle. ISO 13485:2016 is the recognised standard for medical device QMS. For Class IIa and above, the QMS must be assessed by the Notified Body. Key elements include design controls, post-market feedback, CAPA processes, and document management. Eclevar MedTech is ISO 13485:2016 certified.
ISO 13485 guideFor Class III devices and cases where existing clinical evidence is insufficient for CER requirements, pre-market clinical investigations must comply with ISO 14155:2020 — the Good Clinical Practice standard for medical device trials. All investigations require ethics committee approval, EUDAMED registration, and national competent authority notification. Post-market clinical investigations (PMCI) follow the same GCP standard.
Clinical investigations guideEU MDR introduced mandatory Periodic Safety Update Reports (PSUR) for Class IIb (every 2 years) and Class III (annually). The Summary of Safety and Clinical Performance (SSCP) must be produced for Class III and implantable devices and published in EUDAMED. Serious incidents and Field Safety Corrective Actions (FSCA) must be reported to the relevant national competent authority within defined timelines.
SSCP guideClinical investigations and PMCF studies under EU MDR must be managed with validated electronic data capture (EDC) systems compliant with 21 CFR Part 11 and ISO 14155:2020. MILO Health — Eclevar's proprietary EDC — is the only platform built natively for EU MDR with Annex XIV mapping, AI-generated eCRFs, and inspection readiness scoring as native architecture.
Clinical data management guideEU MDR 2017/745 is the European Union's medical device regulatory framework that replaced the Medical Device Directive (MDD 93/42/EEC) from 26 May 2021. It applies to all medical devices placed on the EU market and sets requirements for classification, clinical evidence, CE marking via a Notified Body, post-market surveillance, PMCF, and EUDAMED registration. It is significantly more demanding than its predecessor — particularly in clinical evidence requirements and post-market obligations.
Under MDD 93/42/EEC, manufacturers could typically satisfy clinical evidence requirements through literature review and predicate equivalence claims. EU MDR 2017/745 requires systematic clinical evaluation per MDCG 2020-13, active post-market clinical follow-up (PMCF) under Annex XIV Part B, annual/biennial PSUR reporting, and an SSCP for Class III and implantable devices. Many devices have also been reclassified upward — including software (SaMD), substance-based devices, and reprocessed single-use devices.
Class III devices under EU MDR face the strictest requirements: full Notified Body technical file review (Annex IX scrutiny procedure in many cases), clinical investigation data typically required under Article 61, a comprehensive CER per MDCG 2020-13, annual PSUR reporting, an SSCP published in EUDAMED, and a 10-year PMCF architecture for AIMDs. For Class III devices with a drug component, mandatory consultation with EMA or a national medicines authority is required during conformity assessment.
Key 2025-2026 developments: MDCG 2025-6 on AI Act and MDR interplay for SaMD; Regulation (EU) 2024/1860 extending transitional provisions for legacy MDD devices until 2027-2028; expanded EUDAMED mandatory functionality including UDI registration and clinical investigation tracking; heightened NB scrutiny on PMCF Plan quality; and EMA-NB coordination for drug-device combinations becoming standard practice. See the full update section above for detailed analysis.
From this hub, navigate to any specific EU MDR topic with dedicated expert guides.
Eclevar MedTech's team includes former TUV SUD and Notified Body reviewers — the only CRO that understands EU MDR from both sides of the conformity assessment table. From classification to PMCF to Notified Body submission, we design programs that are ready for scrutiny from version 1.
