EU compliance explainers and checklists.
MDR and IVDR guides
Regulatory news and changes
EUDAMED registration is mandatory from May 2026 under Article 33 MDR. Complete step-by-step guide: SRN registration, UDI-DI assignment, EC REP registration…
Which Notified Bodies have capacity for MDR certification in 2026? Acceptance status, estimated queue times, and certification timelines for TÜV SÜD, BSI, TÜV…
MDR certification takes 13–18 months on average in 2026. 7 proven steps to reduce certification time: NB selection, complete technical file, Annex IX vs X…
Locate relevant EU compliance paths
Submit a structured request to find a Notified Body for MDR 2017/745 conformity assessment.
Submit a structured request to find a Notified Body for IVDR 2017/746. AFINA matches your IVD device class and scope to Notified Bodies with current capacity…
Every medical device and IVD manufacturer needs a Person Responsible for Regulatory Compliance (MDR / IVDR Art. 15); micro and small enterprises may have one permanently at their disposal instead of in-house. Submit one request — the scope can be matched with PRRC service providers.
Representative roles and mandates
Representative setup on getEAR.eu
IVD representation route on getEAR.eu
If your device also embeds a high-risk AI system, on representAI.eu
If your product is a cosmetic, not a device, on getCosmeticRP.eu
For CMR substances in your device requiring separate REACH compliance, on getREACHOR.eu
Decision aids and cost guides
General decision guide on getCE.eu
Guides and explainers
Which MDR conformity assessment route applies to your device? Complete breakdown of Annex IX, X, and XI by device class (I, IIa, IIb, III) under Regulation EU…
MDR certification takes 13–18 months on average in 2026. 7 proven steps to reduce certification time: NB selection, complete technical file, Annex IX vs X…
Send us the product details and we will tell you the next compliance step.