News

The European Commission has published a Q&A document clarifying the requirements under Article 10a of the MDR/IVDR, introduced by Regulation (EU)…

MDCG 2024-15 provides manufacturers and sponsors with guidance on publishing clinical investigation reports and their summaries while EUDAMED is not…

The revised MDCG 2023-3 guidance introduces changes for manufacturers:

1. Stricter Reporting Obligations:
   • Introduction of the "awareness date" as the…

NSF PROSYSTEM has successfully passed the DNV MEDCERT audit according to ISO 13485 and has again been re-certified. The scope covers the assessment,…

The MDCG has published the guideline 2024-13, which clarifies the regulatory status of ethylene oxide (EtO) for medical device sterilization. EtO, an…

On October 21, 2024, the major groups of the European Parliament published a joint resolution, urging the newly elected EU Commission to take…

The guidance document MDCG 2021-25 was updated in October 2024 to reflect changes brought by Regulation (EU) 2023/607. Key updates include…

At the beginning of October, the Medical Device Coordination Group (MDCG) presented the new document MDCG 2024-12. It provides comprehensive…

Beginning October 1, 2024, FDA will offer a transition period during which the Small Business Determination (SBD) can also be submitted electronically…