Question 1

What are the EU MDR and IVDR regulations and why are they important?

Accepted Answer

The EU MDR (Medical Device Regulation 2017/745) and EU IVDR (In Vitro Diagnostic Regulation 2017/746) are the primary regulations governing medical devices and IVDs in the European Union. MDR fully replaced the Medical Devices Directive (MDD) on May 26, 2021, while IVDR applies from May 26, 2022. These regulations establish harmonized rules for safety, performance, clinical evaluation, post-market surveillance, and traceability (UDI) across all EU member states. Compliance requires CE marking through notified body certification, EUDAMED registration, and appointment of an EU Authorized Representative for non-EU manufacturers.

Question 2

What is MDCG and what guidance documents have been released in 2025?

Accepted Answer

The Medical Device Coordination Group (MDCG) is the European Commission's expert group that develops guidance documents to support harmonized implementation of MDR and IVDR. Major 2025 guidance includes: MDCG 2025-6 (FAQ on interplay between MDR/IVDR and the AI Act - addresses high-risk Medical Device AI compliance), MDCG 2025-5 (performance studies for IVDs), and MDCG 2025-4 (safe distribution of medical device software apps on online platforms). These guidance documents are non-binding but highly influential for regulatory interpretation across EU member states.

Question 3

What is a Notified Body and why is designation capacity important?

Accepted Answer

A Notified Body is an independent conformity assessment organization designated by EU member states to conduct CE marking assessments for Class I sterile/measuring, Class IIa, IIb, and III medical devices under MDR, and all IVDs except general IVDs under IVDR. As of 2025, notified body capacity remains limited with long review queues. This page tracks notified body designation news, suspension/withdrawal announcements, and capacity expansion updates from premium regulatory intelligence sources.

Question 4

How does the EU AI Act affect medical device manufacturers?

Accepted Answer

The EU Artificial Intelligence Act (effective 2026) classifies medical device AI systems as high-risk by default. MDCG 2025-6 (June 2025) clarifies the interplay: manufacturers must integrate AI Act requirements including bias mitigation, transparency, cybersecurity, and human oversight into existing MDR/IVDR quality management systems. Medical device software (MDSW) with AI functionality requires dual compliance with both MDR/IVDR and AI Act obligations.

Question 5

What is EUDAMED and when will it be fully operational?

Accepted Answer

EUDAMED (European Database on Medical Devices) is the EU's centralized database for device registration, UDI/UDI-DI data, certificates, clinical investigations, and post-market surveillance. Full functionality implementation continues in phases. Manufacturers must register devices in EUDAMED and submit UDI-DI data to obtain UDI carrier labels. This page tracks EUDAMED module launch announcements and operational updates from European Commission sources.

Question 6

What is an EU Authorized Representative and do non-EU manufacturers need one?

Accepted Answer

An EU Authorized Representative (EC-REP) is a legal entity established in the EU required for all non-EU medical device manufacturers. The EC-REP acts on behalf of the manufacturer in regulatory interactions with national competent authorities, including MDR/IVDR compliance, post-market surveillance, incident reporting, and market surveillance coordination. All non-EU companies must appoint an EC-REP to place medical devices on the EU market. Learn more in our EU Authorized Representative selection guide.

Question 7

How can I stay updated on EU MDR, IVDR, and MDCG guidance changes?

Accepted Answer

This page automatically aggregates EU MDR, IVDR, and MDCG news from 7 premium regulatory intelligence sources daily, including RAPS, Emergo by UL, Citeline MedTech Insight, and Pure Global's EU research team. Pure Global provides comprehensive regulatory support for Europe market access.

Question 8

What sources does this EU regulatory news page aggregate from?

Accepted Answer

We aggregate EU, MDR, IVDR, and MDCG news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Emergo by UL, Citeline MedTech Insight, Asia Actual, Pure Global's proprietary EU research team, Pacific Bridge Medical, and Qualtechs. All sources are filtered to show only EU-related regulatory updates using advanced keyword matching including MDR, IVDR, MDCG, notified body, and EU-specific terminology.

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