IVDR Compliance Services

What is IVDR?

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) governs all diagnostic test kits, blood glucose meters, pregnancy tests, laboratory analysers, and companion diagnostics placed on the EU market. IVDR replaces the old IVDD and introduces significantly stricter requirements — including Notified Body involvement for most devices that were previously self-certified.

IVDR Classification — Four Classes

Class B Deadline — May 2027

The Class B compliance deadline is May 2027. That is less than nine months away. Companies that have not started their IVDR compliance programme are already behind. Notified Body pre-submission slots are months out. If you have Class B IVDs on the EU market, the time to act is now — not in 2027.

What NordMDR Provides for IVDR

• EU Authorised Representative (EU AR) under IVDR — mandatory for all non-EU IVD manufacturers
• EUDAMED actor registration (SRN) and device/UDI registration
• IVDR classification analysis — confirm your device class before building any documentation
• Technical documentation — performance evaluation, risk management, labelling, IFU
• Transition strategy from IVDD to IVDR — gap assessment and compliance roadmap
• Notified Body selection and pre-submission support for Class B, C and D
• Post-market performance follow-up (PMPF) plans and periodic summary update reports (PSUR)

EU Authorised Representative for IVD Manufacturers

If your manufacturing site is outside the EU or EEA, you must appoint an EU Authorised Representative before placing any IVD on the EU market under IVDR. The EU AR name and address must appear on your device label. NordMDR AB acts as EU AR for IVD manufacturers across Asia, the Americas, and beyond.

NordMDR AB provides EU Authorised Representative and EUDAMED registration services for IVD manufacturers — combine with our EU MDR compliance support if you also place medical devices on the EU market.