2017/745/EU Medical Devices Regulation

2017/745/EU Medical Devices Regulation

Regulation (EU) 2017/745 on medical devices, known as the Medical Device Regulation (MDR), introduced a more robust, transparent and sustainable regulatory framework for medical devices in the European Union.

The MDR places strong emphasis on patient safety, product performance, clinical evidence, post-market surveillance, vigilance, traceability and the responsibilities of all economic operators involved in the medical device supply chain.

The Regulation entered into force in 2017 and has applied since 26 May 2021, replacing the previous medical device directives. It introduced increased requirements for manufacturers, notified bodies, authorised representatives, importers and distributors, particularly in relation to technical documentation, clinical evaluation, quality management systems, post-market activities and conformity assessment procedures.

Important points for manufacturers

Manufacturers intending to place medical devices on the EU market should carefully assess the applicable MDR requirements at an early stage of the certification process. Learn more about the important points for manufacturers.

You can see our notified scope in the following link to NANDO database

For any questions and information request please send an e-mail to application@udemadriatic.com