CE certification under EU MDR 2017/745.
The European Medical Devices Regulation (EU) 2017/745 replaced the MDD in May 2021 and significantly raised the bar for clinical evidence, QMS requirements, and post-market obligations. We guide manufacturers through the full EU MDR pathway — technical documentation, clinical evaluation, notified body liaison, and ongoing compliance.
EU MDR 2017/745 classifies devices into Class I (including Is, Im, Ir), IIa, IIb, and III using rules defined in Annex VIII. The classification determines whether a notified body is involved and the depth of conformity assessment required. Class I non-sterile, non-measuring, non-reusable surgical devices can self-certify under Annex IV; all others require notified body assessment of the technical file or full quality system under Annex IX, X, or XI.
We review your device against each Annex VIII rule, confirm the classification, and identify the optimal conformity assessment route. For devices borderline between classes — common with software, combination products, and accessories — we prepare a written classification rationale that your notified body can review and accept before you commit to a full dossier.
Where you have an existing MDD technical file, we assess what MDR-specific additions are required. EU MDR demands substantially more clinical evidence than MDD, and clinical evaluation now requires a clinical evaluation plan (CEP), literature-based clinical evaluation report (CER), and a clinical evaluation follow-up (PMCF) plan from the outset.
Written classification rationale citing Annex VIII rules, with discussion of any borderline or dual-classification issues and recommended conformity assessment route.
Identifies applicable GSPRs, conformity assessment route, notified body requirements, expected timeline, and clinical data gap analysis.
Clause-by-clause comparison of your existing MDD dossier against EU MDR Annex II/III requirements, identifying what must be added or updated.
EU MDR Annex II defines the content of technical documentation for the device itself; Annex III covers post-market surveillance technical documentation. Together they require: device description and specification (including variants and accessories), information supplied by the manufacturer (IFU, labelling), design and manufacturing information, general safety and performance requirements (GSPR) checklist per Annex I, benefit-risk analysis and risk management per ISO 14971:2019, product verification and validation data, and clinical evaluation.
We build the full technical documentation file from your existing engineering outputs and identify gaps. Where design records, test reports, or risk files are incomplete, we work alongside your engineering team to close them. The final dossier is structured to notified body expectations, with a clear declaration of conformity and an EU MDR-compliant UDI-DI assigned.
Software as a medical device (SaMD) requires IEC 62304 lifecycle documentation and a software safety classification under Annex VIII Rule 11. We prepare the software description, SOUP list, and lifecycle records in formats accepted by EU notified bodies.
Complete Annex I GSPR checklist with evidence references for each applicable requirement, structured for notified body review.
ISO 14971:2019-compliant risk management file including risk analysis, evaluation, mitigation, and residual risk acceptability determination.
Full Annex II dossier compiled, formatted, and cross-referenced, ready for notified body technical review.
EU MDR-compliant DoC with correct Annex references, EUDAMED SRN, and authorised representative details.
EU MDR Article 61 and Annex XIV Part A require clinical evidence sufficient to demonstrate conformity with GSPRs 1, 6, and 8. For most devices this means a systematic literature review, equivalent device analysis (if applicable), and clinical evaluation report (CER). The CER must be authored or reviewed by a qualified clinical evaluator as defined in MEDDEV 2.7/1 Rev.4 — a person with at minimum a relevant medical degree and two years of specialist clinical experience.
Post-market clinical follow-up (PMCF) is mandatory under Annex XIV Part B for Class IIa and above. The PMCF plan must describe specific methods to gather clinical data from the marketed device — registry participation, post-market studies, user surveys with statistical rationale — and the results must feed back into the clinical evaluation. We draft the PMCF plan alongside the CER so the two documents are coherent and notified body-ready from the start.
Systematic scope definition, appraisal criteria, and equivalence rationale, prepared as the governing document for the CER.
MEDDEV 2.7/1 Rev.4-compliant CER with structured literature appraisal, equivalence justification (if used), and clinical benefit/risk conclusion.
Annex XIV Part B-compliant PMCF plan specifying data collection methods, timelines, statistical justification, and how outputs feed into CER updates.
Ready to move forward?
Tell us your device class, target markets, and whether you have existing MDD documentation. We will map out the EU MDR path and clinical data requirements.
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