ECM Academy organises a training course addressed to manufacturers of medical devices currently on the market in compliance with Directive 93/42/EEC according to article 120 of the MDR (so-called Legacy Devices).

Legacy Devices are devices, certified according to the MDD, placed on the market in derogation of the MDR Regulation. These devices can therefore continue to be marketed during a transitional period only if the requirements of Article 120 of the MDR Regulation 2017/745 are met.

The Course proposed by ECM will describe how to apply the requirements of art. 120 of the MDR to devices already certified MDD, providing the tools to optimize regulatory strategies in order to produce adequate clinical evidence.

MAIN TOPICS

• The Guideline MDCG 2021-25 “Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC”
• The Guideline MDCG 2020-6 “Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC – A guide for manufacturers and notified bodies”
• How to efficiently develop a PMS Plan according to standard ISO/TR 20416:2020 “Medical devices – Post-market surveillance for manufacturers”

ORGANISATION OF THE COURSE

The course will be divided into two 4-hours modules, which can be attended separately:

• MODULE 1 – TECHNICAL/NORMATIVE: technical/knowledge in-depth study on the Regulation (EU) 2017/745 and the MDCG guidelines
• MODULE 2 – EXPERIMENTAL: regulatory overview + practical training on post-market surveillance activities.

The speaker of the course is the ECM Clinical Manager, Dr. Marianna Mastroroberto.

WHERE AND WHEN

The Course will take place exclusively online, remotely.

• 22 February 2022: Italian language edition
• 24 February 2022: English-language edition.