European Union · Global Market Access
Entering the EU Market: Medical Devices (MDR)
Medical Device Regulation — a notified body is involved depending on the risk class.
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01What is it?
The Medical Device Regulation governs the placing of medical devices on the EU market and is markedly stricter than the earlier directive on clinical evidence, post-market surveillance and traceability.
02Why Does This Scheme Exist?
The Medical Device Regulation replaced the earlier directives, and that change is the consequence of a series of events. High-profile implant cases showed two structural weaknesses in the old regime: the strictness of notified bodies' scrutiny varied markedly between countries, and post-market data collection was weak. Once a device had obtained its certificate, its performance in the field was not monitored systematically.
The new regulation intervenes directly at those two points. The notified bodies themselves were put through a stricter redesignation process and their number fell; this narrowed certification capacity and became the greatest bottleneck of the transition.
The second intervention is the raising of the clinical evidence threshold. Carrying out a clinical evaluation by reference to an equivalent device has become markedly harder; equivalence must now be shown in technical, biological and clinical terms and the right of access to the equivalent device's data must be evidenced.
The third structural change is the systematisation of POST-MARKET SURVEILLANCE: the surveillance plan, the periodic safety update report and clinical follow-up are now permanent parts of the technical file. A device's conformity is not a state obtained once and set aside but a file that is continuously fed.
An arrangement was also established for giving devices a unique identifier and registering them in a common European database; traceability and the effectiveness of recalls rest on that registration. A manufacturer outside the EU must have an authorised representative established in the EU and a person responsible for regulatory compliance within the organisation.
03Whose Obligation?
The obligation lies with the manufacturer. For manufacturers outside the EU an AUTHORISED REPRESENTATIVE established in the EU IS MANDATORY. A person responsible for regulatory compliance (PRRC) must also be in place.
04Required Documents
- The device description, intended purpose and classification rationale
- Technical documentation and post-market surveillance documentation
- The risk management file
- Clinical evaluation report
- ISO 13485 quality management system records
- Biocompatibility, sterilisation and packaging validation reports
- UDI information and EUDAMED registration
- Authorised representative agreement
05Process
- 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
- 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
- 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
- 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
- 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
- 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
- 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
- 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.
06Points to Watch
- For devices other than Class I a notified body comes into play
- Placing on the market is not possible without appointing an authorised representative and a PRRC
- Transitional provisions are conditional; different dates apply according to device class
- Software can be a medical device; Rule 11 is decisive in classification
07Neighbouring Schemes and the Difference
- 01MDR and IVDRIVDR covers in vitro diagnostic devices and its risk classification is built on an entirely different logic; where under the old regime most diagnostic kits passed on manufacturer declaration, under IVDR the majority came within the scope of a notified body.
- 02MDR and machinery legislationEven where a device intended for a medical purpose has moving parts, the governing regime is the MDR; the relevant essential requirements of machinery legislation are met within the MDR file.
- 03MDR and ISO 13485ISO 13485 is a quality management system standard and is used as the practical expression of the quality system the MDR requires; but a system certificate does not demonstrate the conformity of the device, which requires a separate assessment.
- 04MDR and UK MDRThe United Kingdom operates its own medical device arrangement; a certificate obtained in the EU is not directly valid there and a responsible person established in the country is required.
08Scheme Detail
This page describes entry into the European Union market. The scheme itself — its scope, process, validity period and required documents — is covered in detail on the certification page.
Medical Device Directive (MDR) and CE Marking10Frequently Asked Questions
This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.
The certification timeline varies with the product, the required test workload, sample shipping time and the authority's workload; for this reason, no duration in days or weeks is given on these pages. The main factors determining the timeline are: whether testing must be performed in the target country, whether a factory audit is required, the time to appoint a local representative, and the current maturity of the technical file. A realistic timeline for your product is provided in writing at the quote stage.
Market access regimes change frequently: scope lists are updated, transition periods are extended, new requirements are added. These pages describe the structure of the regime and who bears the obligation; the applicable scope and dates for your product are confirmed from the current legislative text at the quote stage.
European Union · MDR roadmap for
Tell us about your product; we'll share the required steps, documents and timeline in writing.