How do you achieve MDR approval for your medical device without project delays?
We guide medical devices of classes I through III through the Medical Device Regulation (EU) 2017/745 - from the gap analysis through the technical documentation and the clinical evaluation to certification by the notified body. The sore point is rarely the regulation itself, but the sequence: those who align classification, clinical evidence and notified body capacity early avoid the iterations that delay MDR projects by months.
- MedTech
Overview
What requirements does the MDR place on manufacturers?
Support across all classes I-III · MDR (EU 2017/745), ISO 13485:2016, ISO 14971
Last updated: 2026-06-12
The Medical Device Regulation (EU) 2017/745 has replaced the MDD 93/42/EEC and significantly tightened the requirements for medical devices of classes I through III. The four levers on which projects most often get stuck:
- Stricter clinical evidence requirements: the clinical evaluation per Art. 61 and Annex XIV demands robust clinical evidence; the equivalence route is heavily restricted compared with the MDD and requires, among other things, access to the technical documentation of the comparator device.
- Complete technical documentation per Annex II and III, consistently linked to a GSPR checklist per Annex I - the specific evidence for each requirement.
- Mandatory UDI and EUDAMED registration as well as conformity assessment via a notified body from class IIa onward (and for sterile/measuring class I devices).
- Systematic post-market surveillance per Art. 83-86 including PMS plan, PSUR and PMCF - as a continuous system, not a one-off document.
Services
How we support you
Gap Analysis & MDR Strategy
Target/actual comparison against the MDR requirements, classification per Annex VIII and definition of the conformity assessment route including selection of the notified body.
Technical Documentation & UDI
Development and maintenance of the technical documentation per Annex II/III, GSPR checklist per Annex I, UDI implementation and EUDAMED registration.
Learn more →Clinical Evaluation & PMCF
Clinical Evaluation Report per Art. 61 and Annex XIV, assessment of evidence needs and planning of PMCF activities to secure evidence after market launch.
Learn more →Post-Market Surveillance & Vigilance
PMS plan and PSUR per Art. 84-86, establishment of the vigilance and reporting system per Art. 87 et seq.
Learn more →How we work together
What it comes down to
The Medical Device Regulation (EU) 2017/745 does not demand more documents, but more robust evidence. Three strands must fit together, and in the right order: the classification per Annex VIII determines the conformity assessment route. The technical documentation per Annex II/III must substantiate every General Safety and Performance Requirement from Annex I with specific evidence. And the clinical evaluation per Art. 61 and Annex XIV must show that this evidence is backed by clinical data. Whoever starts one of these strands too late loses it as the critical path - usually the clinical evaluation.
This is exactly where we come in: at the outset, the gap analysis makes visible which strand is critical, before notified body capacity is booked and technical documentation is written. That shifts the effort forward - to where corrections are inexpensive, instead of into the audit, where they push the project back by months.
Our approach
Our approach
Step
Result
Gap Analysis
Prioritized action list: where the documentation stands against the MDR, what is critical, what is effort.
Classification & Strategy
Confirmed device class per Annex VIII, defined conformity assessment route, selected notified body.
Technical Documentation
Technical documentation per Annex II/III, fully substantiated against the GSPR checklist.
Clinical Evaluation
CER per Art. 61/Annex XIV with a robust evidence base and PMCF plan.
Submission & Notified Body
Submitted application, supported audit, structured resolution of findings.
Certification & PMS
CE marking granted, PMS and vigilance system operational.
Common pitfalls
Where projects commonly fail
The clinical evaluation is started too late.
If the available clinical evidence per Art. 61 is insufficient and the equivalence route is blocked, there is no time to generate proprietary clinical data - the most common reason for serious findings from the notified body.
The GSPR checklist per Annex I is incomplete or not linked to specific evidence.
The notified body requires the substantiation in the technical documentation for each individual requirement - blanket references lead to additional requests.
Notified body capacity is planned too late.
Contract closure and audit slots have long lead times; an application without mature technical documentation creates correction loops instead of a straight path to certification.
Classification per Annex VIII is underestimated.
Up-classifications under the MDR - for example software per Rule 11 or substance-based devices - are overlooked and entail a more demanding conformity assessment route than originally planned.
Post-market surveillance is treated as a closing document.
PMS plan, PSUR and PMCF per Art. 83-86 are an ongoing system; without integration into QM and risk management per ISO 14971, a gap arises that surfaces in the surveillance audit.
FAQ
Frequently asked questions
Sources
- Regulation (EU) 2017/745 (MDR) - primary text, Art. 10, 52, 61, 83-92, Annex I, II, III, VIII, XIV
- ISO 13485:2016 - Quality management systems for medical devices
- ISO 14971 - Application of risk management to medical devices
- https://theentourage.de/expertise/mdr-konformitaet/ (existing page content, revised)
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Case Studies
What this looks like in practice
Related insights
All insights →Regulations & standards considered
- EU 2017/745 (MDR)
- MDR Annex I (General Safety and Performance Requirements, GSPR)
- MDR Annex II/III (Technical Documentation)
- MDR Annex VIII (Classification Rules)
- MDR Annex XIV (Clinical Evaluation & PMCF)
- MDR Art. 61 (Clinical Evaluation)
- MDR Art. 83-86 (Post-Market Surveillance)
- MDR Art. 87-92 (Vigilance)
- ISO 13485:2016 (QM System)
- ISO 14971 (Risk Management)
Related topics
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