Extension of the MDD Certificate for Our Medical Devices Supporting Women’s Wellness at Every Stage of Life The MDR Regulation, in effect since May 2017 and applicable from May 2021, governs medical devices in Europe. Deadline extensions allow the marketing of devices compliant with the Medical Device Directive (MDD) until December 31, 2027, for class…
MDR Transition Period Extension: FarmaImpresa Ensures Compliance for its Legacy Devices until 2028 The MDR (Medical Device Regulation), which came into force in May 2017 and has been applicable since May 2021, aims to create a robust and transparent regulatory framework for medical devices in Europe, ensuring safety and promoting innovation. However, because of concerns…
MDR: Innovations and Implications for Medical Devices Based on Substances Regulation (EU) 2017/745 has introduced significant innovations in the field of medical devices, particularly those composed of substances. However, the distinction between these and medicines can be blurred, leading to lengthy and complex discussions. The European Commission’s MDCG 2022-5 guide aims to clarify these contentious…
EU Regulation 607/2023: Extension of certificates and marketing for medical devices – Clarification and conditions On March 20, 2023, EU Regulation 607/2023 was published in the Official Journal of the European Community, extending the transitional period for medical device certificates and market entry, eliminating the sell-off period. On March 24, the Q&A document on practical…
With the adoption of the European Regulations 2017/745 MDR (Medical Device Regulation) and 2017/746 IVDR (In Vitro Diagnostic Regulation), the regulations for medical devices and in vitro medical devices have changed dramatically. The main objectives of the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are to “establish a robust, transparent, predictable, and…