Quick answers to common questions about compliance, documentation and conformity assessment under EU MDR (2017/745) and IVDR (2017/746).
No. Many Class I devices can be self‑declared, but certain Class I subcategories (Is/Im/Ir) and higher classes require Notified Body involvement.
MDR requires an appropriate QMS; ISO 13485 is the most common framework used to demonstrate this in practice.
Annex II describes the structure and content of the technical documentation. Annex III focuses on post‑market surveillance (PMS) documentation, including plans and reports.
PRRC is required under MDR. EUDAMED/UDI obligations depend on module availability and your role; we help you navigate the requirements.
Common bottlenecks include misclassification, weak GSPR mapping, insufficient clinical evidence for the intended purpose/claims, and QMS not being audit‑ready for Notified Body review.
No - we provide regulatory strategy and consulting; the actual conformity assessment for your device class is carried out by an independent accredited Notified Body. If you need to find one, you can search EU compliance providers independently.
IVDR (EU 2017/746) is the EU regulation for in vitro diagnostic medical devices (IVDs). It applies to IVDs and related accessories placed on the EU market.
IVDs are classified into Classes A, B, C and D based on intended purpose and risk. Correct classification sets your conformity assessment route and evidence expectations.
See IVD classification (IVDR).
Under IVDR, performance evaluation is the framework for demonstrating scientific validity, analytical performance and clinical performance. It is not identical to MDR clinical evaluation, although the concepts are related.
See Performance evaluation (IVDR).
Yes, in most cases. All Class B, C and D IVDs need a Notified Body, and sterile Class A IVDs need one for the sterility aspects; only non-sterile Class A IVDs are self-declared. The exact route depends on class and the selected conformity assessment procedure.
Common issues include unclear intended purpose, underestimating evidence needs (especially clinical performance), and timelines for Notified Body availability.