Paris, 27 May, 2021 – The European Regulation (EU) No 2017/745 dated April 5, 2017, relating to medical devices (hereinafter “the Regulation”) entered into force on May 26, 2021. The Regulation is a replacement of the previous Guidelines 93/42 and 90/385 relating to medical devices. The Regulation was initially scheduled to enter into force on May 26, 2020, but this was postponed for one year in view of the pandemic.
This Regulation modifies and increases several regulatory requirements including, but not limited to, the information necessary for obtaining a CE marking, tracking of medical devices within the European market, and post-market monitoring of medical devices. The definition of medical device is defined at Article 2 of the Regulation and includes, among other things, instruments, implants, devices or software having a diagnostic and/or therapeutic purpose.
As opposed to the previous Guidelines, this Regulation applies directly in all EU member states without requiring any transposition into national law.
This Regulation introduces some new considerations regarding your IP management strategy, especially when it comes to the technical information that must be disclosed to the regulatory authorities by the manufacturers of medical devices. These disclosures should be coordinated with the IP protection of your devices and their environment (software, methods, etc.).
The MedTech working group of REGIMBEAU is at your disposal to consider and implement protection strategies for your IP, particularly in the field of medical devices. We will further discuss the impacts of this Regulation in future articles.
