The Medical Device Coordination Group (MDCG) has released updated preliminary assessment review templates for the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). These updates aim to enhance the designation process of notified bodies under EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Key Details
New Templates for Regulatory Support
The newly released documents, MDCG 2024-7 Rev. 1 for MDR and MDCG 2024-8 Rev. 1 for IVDR, provide detailed preliminary assessment review templates. These templates are crucial tools for organizations applying for designation as notified bodies under the respective regulations.
Targeted Audience
These updates are vital for regulatory professionals, medical device manufacturers, and notified bodies aiming to streamline their compliance processes with EU regulations. The templates offer insights into compliance assessments, ensuring clarity and efficiency during evaluation procedures.
Call for Review
Regulatory professionals and manufacturers are strongly encouraged to review the updated templates. These documents provide essential guidance to ensure compliance with regulatory standards.
Documents Available for Download
- MDCG 2024-7 Rev. 1 Preliminary Assessment Review Template – MDR
Includes the Annex to the Application Form & PAR Template (Regulation EU 2017/745). - MDCG 2024-8 Rev. 1 Preliminary Assessment Review Template – IVDR
Includes the Annex to the application form for Regulation EU 2017/746.
Both documents are available for immediate download, offering a comprehensive overview of regulatory expectations and aiding stakeholders in the designation process.
These updates from the MDCG underline the evolving nature of medical device regulations in the EU and highlight the continuous effort to improve compliance frameworks for manufacturers and notified bodies. Stakeholders should act promptly to align with the latest requirements.
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