Commercial 4Easy PRRC Commercial 4Easy PRRC

MDCG 2024-7 Rev. 1Revised Preliminary Assessment Review (PAR) Templates for MDR Now Available

The revised Preliminary Assessment Review (PAR) templates under the MDR (Regulation (EU) 2017/745) bring critical updates for Notified Bodies and the medical device industry. Published by the Medical Device Coordination Group (MDCG) in January 2025, the revisions focus on simplifying regulatory processes, including the removal of redundant sections and enhancing annexes for detailed guidance. These updates are essential for companies aiming for regulatory compliance, CE marking, and alignment with European medical device regulations.

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Commercial 4Easy PRRC Commercial 4Easy PRRC

Smart MDR offers an exclusive campaign for startups looking to market their medical devices in the European market!

Smart MDR launches an exclusive campaign for startups and SMEs entering the European medical device market, offering critical regulatory support. Benefit from a 10% discount on CE marking, ensuring your devices comply with EU MDR regulations, and enjoy 6 months of free PRRC services, meeting the Person Responsible for Regulatory Compliance requirement. This campaign simplifies the path to European market access, providing specialized support for medical devices, IVD, and SaMD. With over 20 years of regulatory experience, Smart MDR’s expert team, led by Sandra Balseiro, guides you through the complexities of compliance. This limited-time offer, available until January 31st, is a unique chance to ensure your device's compliance while saving costs. Schedule your meeting today and advance confidently into the European market!

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