EU MDR 2017/745 Explained

An independent overview from DQS, an accredited certification body.

EU MDR 2017/745 is the European Union's regulation on medical devices. It sets out the legal requirements for placing medical devices on the EU market, covering design, manufacture, clinical evaluation, post-market surveillance, and the conformity assessment that culminates in CE marking. The regulation replaced the long-standing Medical Devices Directive 93/42/EEC and the Active Implantable Medical Devices Directive 90/385/EEC, raising the bar for clinical evidence, traceability, and post-market vigilance across all device classes. 

The regulation applies to manufacturers, authorized representatives, importers, and distributors of medical devices intended for the EU market, as well as to manufacturers based outside the EU who sell into it. It is the central reference point for customers, public-health authorities, hospitals, and supply-chain partners who expect proof that a device has been independently assessed against EU requirements. 

Regulation (EU) 2017/745 became applicable on 26 May 2021. Since then it has been amended several times, most notably by Regulation (EU) 2023/607, which extended the transition period for legacy devices certified under the previous directives, and by Regulation (EU) 2024/1860, which introduced a gradual roll-out of the European Database on Medical Devices (EUDAMED), supply-interruption reporting obligations, and additional transitional provisions for in vitro diagnostic devices under the parallel IVDR. The European Commission has also published further proposals in 2025 aimed at simplifying procedural aspects of the regulation; manufacturers should treat the regulatory timeline as live rather than settled.

What is EU MDR 2017/745, from a certification body's perspective? 

From a Notified Body's perspective, EU MDR 2017/745 defines when an independent conformity assessment is required before a medical device may be CE-marked and placed on the EU market. The regulation is directly applicable law in all EU member states. Its conformity assessment routes — quality management system audits, type examinations, and design-dossier reviews — are carried out by Notified Bodies designated by national authorities. 

EU MDR is built on risk-based classification (Classes I, IIa, IIb, III) and on the General Safety and Performance Requirements in Annex I. The Notified Body verifies, through document review and on-site audits, that the manufacturer's quality management system and technical documentation conform to these requirements. A valid certificate, combined with the Declaration of Conformity and CE marking, is the recognized evidence on which hospitals, regulators, and procurement partners rely. 

As a certification body, DQS assesses and certifies conformity, it does not design or implement your quality management system or technical documentation. That independence is what gives a CE certificate its value: the manufacturer builds and maintains the system, and a designated Notified Body verifies it against the regulation. DQS Medizinprodukte GmbH is designated and operates as Notified Body 0297 under Regulation (EU) 2017/745. As part of this designation, DQS Medizinprodukte GmbH is subject to regular oversight and audits by the ZLG, the German authority responsible for the designation and monitoring of Notified Bodies for medical devices.

Key Facts at a Glance 

Context and Drivers Stricter

Clinical Evidence and Post-Market Surveillance

EU MDR raised the requirements for clinical evidence supporting safety and performance claims, particularly for higher-risk and implantable devices. Manufacturers must maintain a Clinical Evaluation Report (CER) and an active Post-Market Clinical Follow-up (PMCF) plan throughout the device life cycle. The regulation also significantly expands post-market surveillance obligations, vigilance reporting timelines, and the documentation that a Notified Body reviews during surveillance audits and recertification. Transition Pressure and Notified Body Capacity Regulation (EU) 2023/607 extended the transition period for certain legacy devices — medical devices that were certified under the previous Medical Devices Directive 93/42/EEC or Active Implantable Medical Devices Directive 90/385/EEC and that continue to be placed on the market under the MDR transitional provisions. These extensions are not automatic in every case. They depend on conditions such as continued compliance with the previous directives, no significant change in design or intended purpose, implementation of an MDR-compliant quality management system and a formal application or written agreement with a Notified Body within the required timelines.

The extended deadlines depend on the device category and risk class. For Class III devices and Class IIb implantable devices, the transition period runs until 31 December 2027. For other Class IIb devices, Class IIa devices, and Class I devices placed on the market in sterile condition or with a measuring function, the transition period runs until 31 December 2028. The same 2028 deadline also applies to devices that were Class I under the previous directives and require Notified Body involvement for the first time under the MDR. For Class III custom-made implantable devices, the relevant transition deadline was 26 May 2026, subject to the specific conditions in the regulation.

EUDAMED, UDI, and Supply-Chain Transparency

EU MDR introduces the European Database on Medical Devices (EUDAMED), the Unique Device Identification (UDI) system, and broader transparency obligations for all economic operators in the supply chain. Regulation (EU) 2024/1860 sets out a gradual, module-by-module roll-out of EUDAMED and the obligation to report anticipated interruptions or discontinuation of supply of certain devices. For customers, regulators, and supply-chain partners, this transparency layer is increasingly the practical evidence base for due diligence on medical devices. As of 28 May 2026, the first four EUDAMED modules are mandatory to use: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance.

Core Requirements

General Safety and Performance Requirements (Annex I)

Annex I sets out the General Safety and Performance Requirements (GSPR) that every device must meet. GSPR cover general principles (chemical, physical, biological properties; risk control; usability), specific requirements for design and manufacture, and requirements for information supplied with the device. Conformity with the GSPR is typically demonstrated through harmonized standards (e.g. ISO 14971 for risk management) or common specifications.

Classification (Annex VIII)

Devices are classified into Classes I, IIa, IIb, and III on the basis of duration of contact, invasiveness, active or non-active nature, and intended use. The classification determines which conformity assessment route applies and whether Notified Body involvement is required.

Quality Management System (Article 10, Chapter II)

Manufacturers must establish, document, implement, and maintain a quality management system that addresses, among other things, regulatory compliance, risk management, design and development, supplier control, post-market surveillance, and incident reporting. ISO 13485 is the harmonized standard widely used as the technical basis for the QMS, although certification to ISO 13485 alone does not constitute conformity with the MDR.

Technical Documentation (Annexes II and III)

Each device requires technical documentation covering device description, design and manufacturing information, GSPR conformity, clinical evaluation, risk-benefit analysis, verification and validation, and post-market surveillance. Technical documentation is reviewed by the Notified Body as part of the conformity assessment.

Clinical Evaluation and Post-Market Clinical Follow-up (Article 61, Annex XIV)

Clinical evaluation is the structured, ongoing assessment of clinical data to verify safety and performance. The Clinical Evaluation Report and the Post-Market Clinical Follow-up plan are central to the conformity assessment for higher-risk devices and to ongoing surveillance.

Conformity Assessment Routes (Annexes IX, X, XI)

Depending on device class and risk, the manufacturer chooses among QMS-based assessment (Annex IX), type examination (Annex X), or production quality assurance routes (Annex XI). For Class III and implantable devices, additional design-dossier review and, where applicable, clinical evaluation consultation procedures apply.

Economic Operators and UDI (Articles 13–16, 27)

The regulation defines duties for manufacturers, authorized representatives, importers, and distributors, including registration in EUDAMED and assignment of UDI codes to devices and packaging. These obligations are designed to ensure traceability from manufacturing through to end use.

Post-Market Surveillance and Vigilance (Chapter VII)

Manufacturers must implement a post-market surveillance system proportionate to the device class, including a Post-Market Surveillance Plan, Periodic Safety Update Reports (PSURs) for higher-risk devices, and vigilance reporting for serious incidents and field safety corrective actions.

Target Groups and Application Areas 

EU MDR applies to any organization that manufactures, imports or distributes medical devices intended for the EU market. This includes manufacturers of implantable devices, active medical devices, surgical instruments, dental products, ophthalmic devices, wound-care products, software as a medical device (SaMD), home-care devices and many products used in hospitals and clinics. It also covers certain device combinations, such as devices incorporating a medicinal substance with an ancillary action, as well as products listed in Annex XVI that do not have an intended medical purpose but are regulated under the MDR because of their similar risk profile. 

The regulation applies regardless of company size: a contract manufacturer producing single-use surgical components and a multinational producing connected implantable devices are both within scope. Non-EU manufacturers must appoint an authorized representative established in the EU to act as their regulatory counterpart. 

For organizations entering the EU market or transitioning legacy devices from the previous directives, MDR conformity is the basis for lawful market access. It provides the documented evidence that regulators, procurement teams, healthcare institutions and supply-chain partners need to verify that a device has been assessed against the applicable EU requirements before it is placed on the market or put into service. 

Related Standards 

Companion Regulation: EU IVDR 2017/746

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) is the parallel regulation to EU MDR. The two share structural concepts such as risk-based classification, GSPR, EUDAMED registration, and UDI, but they apply to distinct device categories. Many manufacturers operate under both regulations and integrate the two within a single quality management system. 

ISO 13485 as the QMS Backbone 

ISO 13485 specifies requirements for a quality management system specific to medical devices and is the harmonized standard most widely used to demonstrate conformity with the QMS requirements of the MDR. Certification to ISO 13485 does not by itself confer EU MDR conformity, but it is the practical basis on which most manufacturers build their MDR-compliant QMS. Many manufacturers maintain both certifications in parallel. 

Risk Management and Related Harmonized Standards

ISO 14971 (application of risk management to medical devices) is the harmonized standard for risk management and is referenced extensively in MDR technical documentation. Other relevant harmonized standards include IEC 62366-1 (usability engineering), IEC 62304 (software life cycle), and a range of product- and process-specific standards. 

MDSAP and Global Market Access 

The Medical Device Single Audit Program (MDSAP) is an audit scheme that allows manufacturers to undergo a single audit covering the QMS requirements of multiple participating regulators (United States, Canada, Brazil, Japan, Australia). MDSAP is not a substitute for EU MDR conformity assessment but is widely used alongside it to streamline multi-jurisdiction market access.

Predecessor Directives 

EU MDR replaced the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). Certificates issued under those directives remain valid during the transition period set out in Regulation (EU) 2023/607, subject to the conditions described above.