CE Marking Under EU MDR — Done Right, First Time
EU MDR 2017/745 is the most demanding medical device regulation in the world. RABT Global’s specialist EU MDR compliance consulting team guides device manufacturers through every stage — from gap analysis and technical documentation to Notified Body certification and EUDAMED registration.
EU Medical Device Directive (MDD) 93/42/EEC has been replaced by EU MDR 2017/745. Key transition deadlines:
- 26 May 2024: MDD certificates expired for most Class IIb and III devices
- 31 December 2027: Extended deadline for certain Class IIb implantable devices
- 31 December 2028: Extended deadline for certain Class IIa and Class I devices with MDD history
If your device holds a legacy MDD certificate, you must be actively progressing your EU MDR compliance programme NOW. RABT Global can assess your current status and build your transition roadmap.
The EU MDR Compliance Journey — Step by Step
EU MDR Gap Analysis:
Assess current status against EU MDR requirements. Identify documentation gaps, classification, and GSPR checklist status.
Device Classification & Registration Strategy:
Confirm EU MDR classification (Annex VIII). Identify Notified Body need. Register economic operator in EUDAMED.
Technical Documentation Preparation:
Compile full Annex II & III technical documentation — GSPR, design & manufacturing data, labeling, IFU, risk management file.
Clinical Evaluation & PMCF Planning:
Prepare CER to Annex XIV. Define PMCF plan. Identify equivalence approach or clinical investigation need.
Notified Body Audit & Certification:
Submit to selected Notified Body. Support NB document review and on-site audit. Obtain EU MDR certificate.
EUDAMED, UDI & CE Marking:
Register device in EUDAMED. Assign UDI. Issue Declaration of Conformity. Affix CE mark. Begin PMS programme.
What Changed: MDD vs EU MDR 2017/745
| Requirement | MDD (Old) | EU MDR 2017/745 (Current) |
|---|---|---|
| Technical Documentation | Product dossier | Full Annex II + Annex III technical documentation |
| Clinical Evaluation | Literature-based CER acceptable | Robust CER to Annex XIV required; higher evidence bar |
| Post-Market Surveillance | Basic PMS plan | Formal PMS plan + PMSR / PSUR mandatory |
| EUDAMED Registration | Not required | Mandatory — device, UDI, economic operator registration |
| UDI (Unique Device Identification) | Not required | Mandatory for all devices |
| EU Authorised Representative | Required for non-EU manufacturers | Strengthened obligations; EUDAMED registration required |
| Notified Body involvement | Class IIa, IIb, III | Class IIa, IIb, III + some Class I (measuring/sterile) |
Our EU MDR Compliance Services — Complete Programme
OUR EU MDR SERVICES
EU MDR Gap Analysis
comprehensive assessment of your current status against EU MDR 2017/745 requirements
Technical Documentation (Annex II & III)
full technical file preparation including device description, design & manufacturing information, general safety and performance requirements (GSPR) checklist
Clinical Evaluation Report (CER)
EU MDR Annex XIV CER preparation, literature review, equivalence assessment, PMCF planning
EUDAMED Registration
registration of your organisation, devices, and certificates in the European database
UDI Assignment & Management
UDI-DI and UDI-PI assignment, GS1/HIBCC system navigation, EUDAMED UDI submission
Notified Body Selection & Audit Support
NB identification, application preparation, and audit readiness programme
Post-Market Surveillance (PMS)
PMS plan, PMSR, PSUR, and PMCF programme management
Declaration of Conformity (DoC)
preparation and review of the manufacturer’s Declaration of Conformity
MDD to MDR Transition Management
assessment and planning of your legacy MDD device transition to EU MDR
EU Authorised Representative Services
statutory EU AR appointment under EU MDR 2017/745 Article 11
Notified Body Selection & Audit Support
Selecting the right Notified Body is one of the most consequential decisions in your EU MDR programme. RABT Global provides expert guidance on:
Notified Body scope — identifying NBs with the required scope for your specific device type and GMDN code
Application preparation — preparing your NB application package including quality management system overview and technical documentation summary
Audit readiness — pre-audit gap analysis, document readiness review, staff preparation for technical reviewer and auditor questions
Audit support — on-site or remote support during NB technical review and audit processes
EU MDR Compliance — Frequently Asked Questions
A: EU MDR 2017/745 became fully applicable on 26 May 2021 for new devices, and 26 May 2024 for the majority of legacy MDD devices. Extended deadlines apply to some device categories under the EU MDR revision (Regulation 2023/607) — including 31 December 2027 for Class IIb implantables and 31 December 2028 for Class IIa and certain Class I devices. RABT Global advises on the applicable deadline for your specific device.
A: Most Class I (self-certified) devices do not require a Notified Body — the manufacturer issues the Declaration of Conformity independently. However, Class I devices that are sterile, have a measuring function, or are reusable surgical instruments DO require NB involvement for specific conformity assessment procedures. RABT Global confirms your NB requirement as part of our classification and registration strategy service.
A: A CER is a systematic review of clinical data supporting the safety and performance of your device. Under EU MDR, the CER must meet the requirements of Annex XIV — with a much higher clinical evidence standard than under MDD. Literature-based equivalence claims are now much harder to sustain. RABT Global’s CER service is fully aligned with MDCG 2020-6 and EU MDR Annex XIV requirements.
A: EUDAMED (European Database on Medical Devices) is the EU’s central database for medical device information. Under EU MDR, registration in EUDAMED is mandatory for economic operators (manufacturers, authorised representatives, importers, distributors) and devices. RABT Global manages your complete EUDAMED registration process.
A: Timelines vary by device class and complexity. Class I self-certification can take 3–6 months. Class IIa to III NB-certified devices typically take 12–24+ months — including NB application, technical documentation preparation, CER, and audit. RABT Global provides a realistic programme timeline during our initial gap analysis.
Navigate EU MDR With Confidence — Partner with RABT Global
Free EU MDR Gap Analysis. Technical documentation. CER. EUDAMED. Notified Body support. One specialist partner for your entire EU MDR programme.