Understanding the MDR 2017/745 regulation in 2026

Regulation (EU) 2017/745, known as the MDR (Medical Device Regulation), became applicable on 26 May 2021 after four years of transition. It replaces Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD) which had governed the European placing on the market of medical devices for thirty years.

For a QA/RA professional, the MDR is not a simple regulatory evolution — it is a deep overhaul of the framework, the requirements and the responsibilities. This guide brings together the essentials to steer a medical device's compliance confidently in 2026.

Why a new regulation?

The previous directives, designed in the 1990s, were showing their limits in the face of the rapid evolution of medical technologies (software, active implantable devices, artificial intelligence, devices without a medical purpose). Several health scandals — notably the PIP breast implant affair and the metal-on-metal hip replacement case — also revealed weaknesses in traceability, post-market surveillance and notified body oversight.

The MDR responds to these issues by:

• Strengthening requirements on technical documentation, clinical evaluation and post-market surveillance
• Extending the scope to products without a strict medical purpose (Annex XVI: cosmetic lenses, lasers, etc.)
• Imposing traceability via Unique Device Identification (UDI) and the European EUDAMED database
• Strictly regulating notified bodies, which must now be designated under the MDR

Scope

The MDR applies to any medical device — that is, any instrument, apparatus, equipment, software, implant, reagent or other article intended by its manufacturer to be used in humans for a specific medical purpose: diagnosis, prevention, monitoring, prediction, prognosis, treatment, alleviation of a disease, injury or disability, or to modify or replace a physiological function.

Also covered are:

• Accessories to medical devices
• Software as a medical device (SaMD)
• Devices without a medical purpose listed in Annex XVI (since Implementing Regulation 2022/2346)
• Custom-made devices with specific procedures
• Systems and procedure packs assembled from several CE-marked devices

Device classification

The MDR keeps the four-risk-class logic (I, IIa, IIb, III) but has revised several classification rules (Annex VIII), with a direct impact on many devices.

Class	Risk level	Typical examples
I	Low	Compresses, wheelchairs, corrective glasses
IIa	Moderate	Hypodermic needles, ultrasound scanners, diagnostic support software
IIb	High	Infusion pumps, defibrillators, X-ray equipment
III	Very high	Cardiac implants, hip prostheses, absorbable devices

Major changes brought by the MDR:

• Rule 11 reclassifies many medical software products into class IIa, IIb or even III depending on their diagnostic or therapeutic impact
• Active implantable devices and their accessories are class III (Rule 8)
• Total and partial hip, knee and shoulder replacements move to class III (Rule 8)
• New rules cover nanomaterials (Rule 19) and devices composed of substances absorbed by the body (Rule 21)

A reclassification implies mandatory notified body involvement, where class I only required self-declaration. This is one of the major challenges of the transition.

Economic operators and their responsibilities

The MDR formalises the role of four categories of economic operators: manufacturer, authorised representative, importer, distributor. Each must register in EUDAMED and bear specific verification and traceability responsibilities.

The Person Responsible for Regulatory Compliance (PRRC)

Article 15 of the MDR — every manufacturer or authorised representative organisation must designate at least one PRRC:

• A university degree in law, medicine, pharmacy, engineering or another relevant scientific discipline
• And at least one year of professional experience in regulatory affairs or quality management systems in the medical device field
• Or four years of professional experience in those same fields

The PRRC ensures compliance before batch release, of the technical documentation, the declaration of conformity, post-market surveillance and vigilance.

General safety and performance requirements

Annex I lists the general requirements every device must meet — this is the heart of compliance. It breaks down into three main chapters:

1. General requirements (1 to 9) — clinical benefit, risk management, lifetime, robustness
2. Requirements regarding design and manufacture (10 to 22) — chemical, biological, microbiological properties, ergonomics, software, active devices, protection against radiation
3. Requirements regarding the information supplied (23) — labelling and instructions for use

The manufacturer demonstrates conformity to these requirements via the harmonised standards published in the Official Journal of the European Union. Presumption of conformity, but not an obligation. The main standards for 2026 include:

• EN ISO 13485:2016 — Quality management system
• EN ISO 14971:2019 — Application of risk management
• EN 62366-1:2015 — Usability engineering
• EN 60601-1 — Electrical safety of medical devices

Technical documentation

Annex II (and III for PMS) details the content of the technical documentation. It is the evidence file for conformity — it must be complete, up to date, and kept available to competent authorities for 10 years (15 years for implantables) after the last placing on the market.

Typical structure:

• Device description and specifications (including variants and configurations)
• Information supplied by the manufacturer (labelling, instructions for use)
• Design and manufacturing information
• General safety and performance requirements
• Benefit/risk analysis and risk management (ISO 14971)
• Verification and validation (preclinical testing, biocompatibility, sterilisation, shelf life)
• Clinical evaluation (Annex XIV) — including the Clinical Evaluation Report (CER) and the clinical evaluation plan
• Post-market surveillance plan and PMCF plan

Clinical evaluation: the MDR's big turn

The MDR has considerably tightened clinical requirements. It is no longer possible, except in very limited cases (legacy devices, strict equivalence), to rely solely on old literature. The manufacturer must:

• Develop a structured clinical evaluation plan
• Demonstrate equivalence with a reference device only if full access to its technical documentation is guaranteed — a condition rarely met
• Conduct clinical investigations for implantable and class III devices, except under strictly framed exemptions (Article 61)
• Keep a Clinical Evaluation Report (CER) up to date throughout the life cycle

PMCF (Post-Market Clinical Follow-up) is now a default requirement for the majority of devices.

Post-market surveillance and vigilance

Chapter VII of the MDR formalises a structured post-market surveillance system:

• PMS Plan — surveillance plan describing proactive and reactive methods of collecting information
• PMS Report (class I) or PSUR (classes IIa, IIb, III) — periodic summary report
• Vigilance — reporting of serious incidents within strict deadlines (15 days, 10 days, 2 days depending on the nature)
• Field safety corrective actions (FSCA) coordinated with competent authorities

Since 28 May 2026, the first four EUDAMED modules (actors, UDI and device registration, notified bodies and certificates, market surveillance) are mandatory; the vigilance and clinical investigation modules are not yet.

CE marking and declaration of conformity

At the end of the conformity assessment (with or without a notified body depending on the class), the manufacturer:

1. Draws up the EU declaration of conformity (Annex IV)
2. Affixes the CE marking to the device and its packaging
3. Registers the device in EUDAMED with the UDI-DI and the information in Annex VI Part B
4. Keeps the technical documentation for 10 years (or 15 years for implantables)

The certificate issued by the notified body is valid for a maximum of five years, renewable after a full audit.

Transition calendar

Devices certified under the former Directive 93/42/EEC may remain on the market according to a calendar extended by Regulation (EU) 2023/607:

• 31 December 2027 — class III devices and implantable class IIb devices (except sutures, staples, dental fillings, braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)
• 31 December 2028 — other class IIb devices, class IIa devices, sterile or measuring class I devices, and Directive class I devices that require a notified body under the MDR

Strict conditions: no significant change to the device, a quality management system compliant with the MDR, a formal application lodged with a notified body before 26 May 2024 and a contract signed before 26 September 2024.

A targeted revision of the MDR and IVDR, proposed by the Commission at the end of 2025, is also under discussion at EU level.

Conclusion: what the MDR changes in a QA/RA professional's day-to-day

In practice, the MDR transforms the regulatory affairs role along three axes:

1. Anticipation — certification lead times have lengthened markedly: an MDR project is planned well ahead of the targeted launch date.
2. Documentation — technical files are much larger than before. Writing and updating must be industrialised.
3. Continuous surveillance — a device's life after placing on the market is now as demanding as the placing on the market itself. The PSUR, the PMCF and vigilance require a lasting organisation.

For QA/RA teams, the challenge is no longer only technical but organisational: having a reliable, automated regulatory monitoring system that lets nothing through. That is precisely what MedQara offers — a platform that continuously aggregates ANSM, the European Commission, EUDAMED and notified bodies, with AI analyses structured by criticality.

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