The EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) sets the safety and performance requirements for medical devices on the European market. It has applied since 26 May 2021 and replaced the old Medical Device Directive (MDD 93/42/EEC). In Türkiye the same requirements are applied through the Medical Device Regulation administered by the Turkish Medicines and Medical Devices Agency (TİTCK).
The CE mark shows that your device meets those requirements and is the precondition for market access. Keeping it matters as much as obtaining it: a notified body certificate stays alive through annual surveillance audits and technical documentation that is kept current.
When is the MDR process needed?
Every manufacturer placing a medical device on the market in the European Union or in Türkiye is subject to the MDR. Planning the process from the start matters in particular when:
- You are developing a new device
- Your device is on the market with an MDD certificate and the transition to an MDR certificate is under way
- You are planning a significant change to the design or intended purpose of your device
- Your notified body has raised a major finding on your file
In Türkiye the device is also registered in the Product Tracking System (ÜTS).
How is a device classified?
The class determines the conformity assessment route you follow and how deeply the notified body reviews your file. The 22 rules in MDR Annex VIII look at the duration of contact with the body, whether the device is invasive, whether it is an active device, and the substances it contains. The result is class I, IIa, IIb or III.
Most non-invasive devices are class I (Rules 1–4). For invasive devices the duration of contact is decisive: transient use (under 60 minutes) is mostly class I or IIa, short-term use (60 minutes to 30 days) IIa and long-term use (over 30 days) IIb (Rules 5–8); direct contact with the heart, the central circulatory system or the central nervous system raises the device to class III. Active devices are classified by function under Rules 9–13, and devices incorporating a medicinal substance with ancillary action are class III (Rule 14). Where several rules apply, the highest class prevails.
Most class I devices do not need a notified body. For class I devices that are sterile, have a measuring function or are reusable surgical instruments (Is, Im, Ir), a notified body reviews the relevant aspects.
The classification should be written down with its reasoning. A short note explaining why a rule applies — and why the others do not — answers the most common audit question up front.
Which documents does CE marking require?
The core document is the technical documentation prepared in line with MDR Annex II and Annex III. It usually contains:
- Device description, intended purpose, variants and the Basic UDI-DI
- Label and instructions for use
- Design and manufacturing information, critical suppliers
- The General Safety and Performance Requirements (GSPR, Annex I) checklist and the standards applied
- The risk management file in line with ISO 14971
- Verification and validation reports: biocompatibility, sterilisation, packaging, shelf life, electrical safety or software, as applicable to the device
- The clinical evaluation report and the PMCF plan
- The post-market surveillance (PMS) plan, plus the PMS report or PSUR depending on the class
On top of that you need a quality management system based on ISO 13485, an EU declaration of conformity and a person responsible for regulatory compliance (PRRC). For class III and implantable devices a summary of safety and clinical performance (SSCP) is also prepared.
How does the transition from MDD to MDR work?
The transition period for devices with MDD certificates was extended by Regulation (EU) 2023/607. Devices that meet the conditions may be placed on the market until 31 December 2027 or 31 December 2028, depending on their class. One of those conditions is that the MDR application was lodged with a notified body by 26 May 2024 and the written agreement signed by 26 September 2024.
No significant change may be made to the design or intended purpose of a device in the transition period. If you are planning a change, first assess whether it counts as a “significant change” under the MDCG 2020-3 guidance.
The real work in the transition is rebuilding the existing MDD file against the more detailed MDR requirements. Clinical evidence, PMS/PMCF and the GSPR mapping usually take the most time. A gap analysis of the current file against the MDR is a good starting point.
How long does the notified body process take?
There is no fixed answer. The duration depends on the class of the device, how mature the file is and the workload of the notified body. Roughly, the process runs through application and quotation, contract, quality system audit, technical documentation review, rounds of questions and the certification decision.
Each round of questions can take weeks. The most effective way to shorten the timeline is to submit a complete and internally consistent file the first time. When choosing a notified body, check in the European Commission’s NANDO database that its designation covers the codes relevant to your device.
What matters for drug-device products?
Devices that incorporate a medicinal substance with an ancillary action — for example drug-coated balloon catheters or drug-eluting stents — are class III under the MDR (Rule 14). For those devices the notified body must consult a medicines authority on the quality, safety and usefulness of the medicinal substance. That consultation is a step to add to the timeline separately.
Where the principal action comes from the medicinal substance in an integral product — a pre-filled syringe, for example — the product falls under medicinal product legislation. In that case an opinion from a notified body on the conformity of the device part with the GSPRs is required (MDR Article 117).
Common problems
- The intended purpose written differently in each document. Different wording on the label, in the instructions for use, in the clinical evaluation and in promotional material opens both classification and clinical evidence to debate.
- A weak equivalence claim. To claim equivalence to another device, the technical, biological and clinical characteristics must all be compared. For class III and implantable devices a contract giving access to the technical documentation of the equivalent device is also required.
- A GSPR table not linked to evidence. Each requirement should name the relevant report and its revision. Every item marked “not applicable” needs a justification.
- Risk management and clinical evaluation living apart. Harms in the risk file should appear in the clinical evaluation, and side effects seen in clinical data should appear in the risk file.
- PMS that stays on paper. The plan exists, but the records do not show how complaint and literature data is collected and assessed.
How the work runs
- Initial assessment — The device, its intended purpose and the target market are clarified; the class and the conformity assessment route are determined.
- Gap analysis — The existing file and quality system are reviewed against the MDR. Gaps are reported with priorities and effort.
- Completing the file — Technical documentation, GSPR mapping, risk management, clinical evaluation and PMS documents are prepared or revised.
- Notified body process — The application is prepared, the audit is attended together, and questions and findings are answered.
- After certification — Support continues for PMS reports, PSURs, surveillance audits and change notifications.
