EU MDR · Regulation (EU) 2017/745
Build the EU pathway around the medical device and its evidence
EU market access for a medical device is not a single registration or approval step. It is a controlled conformity-assessment process connecting intended purpose, risk classification, clinical evidence, the quality system, technical documentation and lifecycle oversight.
Pathway logic
- 04
- Risk classes under Annex VIII
- A
- Ordinary class I devices normally self-declared
- IIa–III
- Notified-body conformity assessment
- 2026
- UDI/Devices module mandatory in EUDAMED
Regulatory orientation
Conformity assessment, not central product approval
The MDR does not create one authority that approves every medical device. The manufacturer remains responsible for compliance, selects the applicable conformity-assessment route and issues the EU declaration of conformity. Notified-body involvement depends on the risk class and characteristics such as sterility, a measuring function or reusable surgical use.
Registration in EUDAMED is a required data step within that wider system. It does not replace classification, clinical evaluation, technical documentation, conformity assessment or CE marking.
Define
Intended purpose, mode of action and device architecture control the route.
Demonstrate
Evidence must support safety, clinical performance and the claimed benefit.
Maintain
Compliance continues through PMS, vigilance and change control.
Regulatory process map
Follow one evidence system through the class-specific route
The class changes the depth and independence of assessment, but every route starts with a defined device and a controlled body of evidence. The diagram shows the principal sequence for a new device placed on the EU market under the MDR.
Scroll horizontally to inspect the complete process map.
Class-specific route
Classification determines who assesses the evidence
Classification follows the 22 rules in Annex VIII and the intended purpose defined by the manufacturer. A classification used in another jurisdiction cannot simply be transferred to the European Union.
Self-declaration route
The manufacturer completes the applicable MDR documentation, issues the EU declaration of conformity and affixes the CE marking without notified-body participation.
Limited notified-body scope
A notified body assesses the relevant sterility, metrological or reusable-surgical-instrument reprocessing aspects. The remaining class I obligations stay with the manufacturer.
Notified-body assessment
The notified body audits the quality system and assesses technical documentation for at least one representative device for each category under the selected route.
Deeper evidence assessment
Notified-body assessment covers the quality system and representative technical documentation for each generic device group. Implantable devices receive additional device-specific scrutiny under the applicable route.
Additional independent controls
Device-specific technical documentation and clinical evidence receive the greatest scrutiny. Certain devices may also trigger the clinical evaluation consultation procedure.
Evidence architecture
Technical documentation is a connected system, not a file collection
Annexes II and III define the documentation structure. The content must remain consistent with the intended purpose, risk controls, claims, product configuration, manufacturing controls and clinical evidence.
Quality management system
The MDR requires a documented QMS proportionate to the risk class and type of device. ISO 13485 is the usual framework, but the QMS must also cover the specific obligations in Article 10(9).
Risk and GSPR evidence
Risk management, benefit-risk determination and the Annex I GSPR checklist must be tied to design inputs, verification, labelling and residual-risk communication.
Clinical evaluation
Clinical data must support safety, performance and the claimed clinical benefit. The evaluation plan and report must be updated across the lifecycle and connected with PMCF where applicable.
Product and manufacturing data
Device description, variants, raw materials, software, manufacturing processes, verification, validation, software, biocompatibility and release controls must describe the released device.
Information supplied
Labels, instructions for use, claims, symbols and language versions must agree with the intended purpose, performance data, residual risks, UDI records and market configuration.
Post-market system
PMS, PMCF, vigilance, trend reporting, periodic reporting and CAPA feed new information back into risk management, clinical evaluation and controlled product changes.
Market-access controls
Complete the legal and data chain before market placement
These workstreams should be planned early. They affect the label, technical documentation, contractual structure, EUDAMED records and release decision.
EU authorised representative
A manufacturer established outside the EU must designate one authorised representative by written mandate. The representative is not interchangeable with a distributor.
Person responsible for regulatory compliance
The manufacturer and, separately, the authorised representative must have access to an appropriately qualified PRRC under the conditions of Article 15.
UDI and EUDAMED
Assign the Basic UDI-DI and UDI-DI under the selected issuing entity rules, register the actor and submit required device data. EUDAMED does not generate the UDI.
Declaration and CE marking
After completing the applicable conformity assessment, issue the EU declaration of conformity and affix the CE marking. Add the notified-body identification number where required.
Importer and distributor controls
Verify economic-operator obligations, traceability, storage, complaint exchange and language coverage before commercial distribution begins.
Legacy-device transition
Transition dates apply only when every condition is met
New devices have had to comply with the MDR since 26 May 2021. The dates shown here apply only to eligible legacy devices covered by Article 120 and do not postpone the MDR requirements that already apply during transition.
Class III and relevant class IIb implantable legacy devices
Other class IIb, class IIa and qualifying class I legacy devices
Conditions include
- No significant change in design or intended purpose
- No unacceptable risk to health or safety
- MDR-compliant QMS in place no later than 26 May 2024
- Formal notified-body application submitted by 26 May 2024
- Written agreement with the notified body concluded by 26 September 2024
These procedural deadlines have passed. A device that did not meet them cannot newly enter the extended transition in 2026. Continued eligibility must be verified for the specific device and certificate.
Regulatory implementation
Keep strategy, evidence and operational controls aligned
MDRC supports individual workstreams or the complete route. The starting point is the product, the claims and the evidence already available, not a generic document package.
Qualification and classification
Scope, intended purpose, Annex VIII rule and route analysis
→ 02Technical documentation
Annex II and III structure, evidence mapping and gap closure
→ 03Quality management system
MDR QMS design, procedures, records and audit readiness
→ 04Clinical evaluation
Clinical evidence strategy, CER, literature review and PMCF planning
→ 05EU authorised representation
Mandate, EUDAMED actor registration and ongoing representation
→ 06PRRC services
Documented Article 15 oversight for eligible organisations
→Official sources
Confirm the route against current EU materials
The regulation controls the legal obligation. Commission and MDCG materials support implementation but must be applied to the actual device and the current state of EU guidance.
Regulation (EU) 2017/745
Current consolidated MDR text on EUR-Lex
MDCG 2021-24 rev. 1
Current guidance on MDR classification rules
EUDAMED UDI and device registration
Current Commission status and implementation materials
MDR transition Q&A
Conditions and deadlines under Regulation (EU) 2023/607
Notified bodies
European Commission information and designation resources
Frequently asked questions
Practical MDR distinctions
The route must be confirmed for the actual intended purpose, technology, sterile status, class and regulatory history.
Are medical devices registered or approved in the European Union?
The MDR establishes a conformity-assessment and CE-marking system, not one central product-approval procedure. The manufacturer demonstrates conformity and issues the EU declaration. A notified body participates where the class or product characteristics require it, while EUDAMED registration forms a separate data obligation.
Which medical devices require a notified body?
Classes IIa, IIb and III require notified-body conformity assessment. Ordinary class I devices are normally self-declared. Class Is, Im and Ir also require a notified body, with its scope limited to the relevant sterility, metrology or reprocessing aspects.
Is ISO 13485 certification mandatory?
The legal requirement is an MDR-compliant quality management system under Article 10(9). ISO 13485 is the principal standard used to structure that system, but certification to the standard does not by itself demonstrate complete MDR conformity.
Does every medical device require a new clinical investigation?
Every device requires a clinical evaluation, but a new clinical investigation is not automatically required for every device. The decision depends on the device, risk class, available clinical evidence and Article 61 requirements. Implantable and class III devices generally require clinical investigations unless an applicable exception can be fully justified.
Does EUDAMED issue the UDI?
No. The manufacturer assigns identifiers under the rules of a Commission-designated issuing entity and then submits the required UDI and device data to EUDAMED. The UDI/Devices module has been mandatory to use since 28 May 2026.
Can a legacy medical device automatically use the extended transition?
No. The extended dates apply only to eligible legacy devices when every Article 120 condition has been satisfied. Classification and the existence of an old MDD or AIMDD declaration or certificate are not sufficient on their own.
Start with the regulatory route
Define the pathway before building the submission package
Tell us the intended purpose, technology, users, current market status and available clinical and technical evidence. We will identify the classification, conformity-assessment route and the most useful next step.
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