Legacy Devices Training Course: new dates available!

24 February 2022

Save the date on 22 and 23 March 2022 with the ECM Academy training for manufacturers of medical devices certified according to Directive 93/42/EEC, pursuant to Article 120 of the MDR.

Following the success of the first edition and the great demand from those who couldn’t attend, the Course “LEGACY DEVICES, how to prepare for the MDD/MDR transition using post-market data in the transitional period” is back.

On Tuesday 22 March in Italian and Wednesday 23 March in English, manufacturers will learn how to apply the requirements of Art. 120 of the MDR to devices that are already MDD certified. Through an integrated study of some of the most relevant guidelines published by the MDCG, participants will acquire useful tools to implement MDR requirements, optimizing resources and ensuring compliance with the requirements.

The theoretical study will then be followed – for those who would like to – by an experimental part, which aims to provide practical ideas for understanding which data must be collected during the transition period and how to do so using post-market tools.

The course will be divided into two 4-hour modules – which can be attended separately by remote, to allow companies to participate on the basis of their needs.

The topics covered include:

  • MDCG Guideline 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”
  • MDCG Guideline 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 effectively design a PMS Plan according to ISO/TR 20416:2020 “Medical devices – Post-market surveillance for manufacturers”
  • The tools for the manufacturer.

For information and costs: Eng. Diego Stevanella – Sales Manager ECM diego.s@entecerma.it | (+39) 393 2471040.