EU MDR CE Marking for Class I, IIa, IIb & III Medical Devices
We take your device from classification to CE certificate under EU MDR 2017/745: technical documentation, clinical evaluation, PMS and PMCF planning, testing and Notified Body coordination, so you reach the EU market without avoidable delays.
What is MDR CE marking?
MDR CE marking shows that your medical device meets the General Safety and Performance Requirements of the EU Medical Device Regulation (EU) 2017/745. Without it, you cannot sell the device in the European Union.
The route depends on risk class. Class I manufacturers self-declare conformity, while Class IIa, IIb and III devices, and sterile, measuring or reusable surgical Class I devices, need a Notified Body to audit the quality system and review the technical documentation before a CE certificate is issued.
Which MDR conformity route applies to your device?
Classification under Annex VIII decides who assesses your device and how long certification takes. Timelines below are typical and depend on file readiness and the Notified Body queue.
| Class | Example devices | Conformity route | Notified Body | Typical timeline |
|---|---|---|---|---|
| Class I | Bandages, walking aids, non-sterile examination gloves | Self-declaration (Article 52(7)) | No (yes for Is, Im, Ir aspects) | 3–6 months |
| Class IIa | Hearing aids, short-term catheters, dental fillings | Annex IX QMS audit + sampled technical documentation review | Yes | 12–18 months |
| Class IIb | Infusion pumps, ventilators, bone fixation plates | Annex IX QMS audit + technical documentation review (each implantable) | Yes | 12–18 months |
| Class III | Heart valves, absorbable sutures, breast implants | Annex IX full QMS + technical documentation review for each device; clinical investigation usually required | Yes | 18–24 months |
The MDR CE marking process, step by step
This is how we take a device from first assessment to CE certificate and beyond.
- 1
Classify the device
All classesWe confirm intended purpose and apply the Annex VIII rules to fix the risk class and conformity route.
- 2
Gap analysis & QMS
All classesWe check your current files against MDR and set up or upgrade your ISO 13485:2016 quality management system to meet Article 10.
- 3
Technical documentation
Annex II & IIIWe prepare the device description, GSPR checklist, risk management file, verification and validation evidence, labels, IFU and PMS documentation.
- 4
Testing & clinical evaluation
ISO 10993 · IEC 60601 · IEC 62304We plan and coordinate testing with associated labs and write the clinical evaluation report under Article 61 and Annex XIV.
- 5
Notified Body assessment
Class Is/Im/Ir, IIa, IIb, IIIWe help you choose a Notified Body, submit the application, prepare for the QMS audit and answer technical documentation questions until closure.
- 6
Certificate, DoC & registration
CE markYou sign the EU Declaration of Conformity and affix the CE mark. We complete UDI assignment, EUDAMED registration and, for non-EU makers, EU Authorised Representative appointment.
- 7
Post-market surveillance
OngoingWe keep you compliant with PMS plans, PMCF, PSUR or PMS reports, vigilance and annual surveillance audits.
What goes into MDR technical documentation?
MDD to MDR transition deadlines
Regulation (EU) 2023/607 extended the transition for legacy devices, but only if the manufacturer met set conditions. These are the dates that matter.
| Date | What it means |
|---|---|
| 26 May 2021 | MDR applies to all new devices placed on the EU market. |
| 26 May 2024 | Deadline to have an MDR quality system in place and lodge a formal application with a Notified Body. |
| 26 Sep 2024 | Deadline for a signed written agreement with the Notified Body. |
| 31 Dec 2027 | End of transition for Class III and Class IIb implantable legacy devices. |
| 31 Dec 2028 | End of transition for other Class IIb, Class IIa and Class I devices that need a Notified Body. |
Our MDR CE marking services
MDR CE marking FAQs
How long does it take to get CE marking under MDR?
Class I (non-sterile, non-measuring) devices are self-declared, so it is mainly the time needed to complete your technical documentation, often 3 to 6 months. Class IIa, IIb and III devices need a Notified Body; plan for around 12 to 18 months, or longer for Class III, depending on the Notified Body queue and how ready your file is.
Do you help with Notified Body selection?
Yes. We shortlist Notified Bodies designated for your device codes, compare scope, review timelines and fees, and support you through the application, audits and technical documentation review.
What happens if my device was CE marked under the MDD?
Legacy MDD devices can stay on the market until 31 December 2027 (Class III and Class IIb implantable) or 31 December 2028 (other classes), provided the conditions of Regulation (EU) 2023/607 are met, including an MDR quality system and a signed Notified Body agreement. We run a gap analysis and upgrade your MDD file to meet MDR.
What documents are needed for MDR CE marking?
The core set is the technical documentation (Annex II), post-market surveillance documentation (Annex III), the GSPR checklist (Annex I), the risk management file (ISO 14971), the clinical evaluation report, labels and IFU, an ISO 13485 quality management system and the EU Declaration of Conformity.
Do non-EU manufacturers need an EU Authorised Representative?
Yes. Under MDR Article 11, a manufacturer based outside the EU must appoint an EU Authorised Representative before placing a device on the EU market. REGHELPS provides this service along with EUDAMED and UDI registration.
Which Class I devices need a Notified Body?
Class I devices that are sterile (Is), have a measuring function (Im) or are reusable surgical instruments (Ir) need a Notified Body for those specific aspects. All other Class I devices are self-declared by the manufacturer.
Not sure which MDR route your device needs?
Send us your device details using the form below and we'll confirm its class and conformity route at no cost.
