Article 15 in the MDR/IVDR uses generally defined terms but leaves some room for interpretation. Close reading of Article 15 in conjunction with other articles of the regulations can help to gain a ...

Dublin, May 06, 2026 (GLOBE NEWSWIRE)-- The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR (Sept 21, 2026)" training has been added to ...

the removal of the “sell-off” periods (MDR and IVDR). As becomes apparent from the above, the changes to the transition periods are limited to the MDR. The transitional regime of the IVDR was extended ...

On March 20, 2023, the new transitional regime for medical devices in the EU and the EEA became effective when Regulation (EU) 2023/607 (the “Regulation”) was published in the Official Journal of the ...

In this webcast, you will learn how to secure your role as an EU compliance professional. Discover the essential steps to earning the RAPS Regulatory Compliance Certification. The Regulatory ...

(MENAFN- GlobeNewsWire - Nasdaq) Professionals have the opportunity to enhance their knowledge on the complex regulatory changes under the MDR and IVDR, gain insights into future developments, and ...

Did you know that both the new Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) for the European Union (EU) include chemical compliance requirements in one of their ...

On 16 December 2025, the European Commission (EC) published a proposal that, if adopted, will harmonise artificial intelligence (AI) Act requirements for medical devices placed on the European market ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...