PUBLISHED MDCG GUIDELINES

• There are several guideline documents published by MDCG which has impact on the industry. Please follow this link and perform impact assessment on your organisation.

COVID-19

• List of COVID-19 essential Medical Devices (MDs and IVDs) available from now. Please follow this link to find out the details.
• European standards for medical supplies made freely available to facilitate increase of production. For more info follow this link.

WHAT IS THE STATE OF PLAY OF THE IMPLEMENTATION OF EUDAMED

• The development and implementation of EUDAMED is a high priority for the Commission
• The Commission, in agreement with the Medical Device Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional
• The module on Actor registration will be the first module made available. Deployment of the module takes place at the latest by March 2021
• The module on UDI/device registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards, the remaining modules will be displayed as soon as they are functional.

UDI

• Through implementing Decision (EU) 2019/939 of 6 June 2019, 4 issuing entities were designated to provide manufacturers with a list of UDIs to assign on medical devices.
• EU Commission have published a FAQ on UDI, please follow this link.

MEDICAL DEVICE CLASS I AND ACTOR REGISTRATION IN SWEDEN

• The 26th of May MPA in Sweden opened the e-service for manufacturer and/or Authorised representatives with location in Sweden to register themselves and their devices. Please follow this link for further information. Note the deadline at 30th of September 2020.

GUIDANCE ON MIR AND UPDATED MIR FORM

• European commission published a Q&A on implementation and use of the 1st version of MIR form.
  • Q&A MIR form
• The form is updated please download the latest version on the links below:
  • MIR version 7.2.1 (PDF)
  • MIR version 7.2.1 (PDF for Excel import)

OTHER EUROPEAN COMMISSION PUBLICATION

• Instructions for Use for reusable and re‐sterilisable Medical Devices. See link.
• Follow this link for the fact sheet on MDR requirements for transparency and Public information. The fact sheet lists information which will be available to the public in accordance with transparency obligations in MDR considering that some requirements will be applicable only once the European database on medical devices (EUDAMED) is fully functional.
• Expert panels have been designated by means of the Commission Implementing Decision (EU) 2019/1396 in relevant medical fields. Get to know them through this link.

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