Information on Medical Devices Regulation (EU) 2017/745

Friday, 19 June 2020 07:33 Medical Devices
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News about the MDR repealing the Medical Devices Directives 90/385/EEC and 93/42/EEC.

  

European Commission

How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used - also in the COVID-19 context.

The purpose of the guide is to provide indications to enable interested parties unfamiliar with the regulated sectors of medical devices and personal protective equipment to identify whether a product is legally placed on the EU market and can continue to be made available, purchased and used.
This clarification has proved particularly necessary in the context of the COVID-19 pandemic. Furthermore, recent experience indicates the need to pay attention to misleading or falsified documents and counterfeit products.

See below

 

 

MDCG - Medical Device Coordination Group

The Medical Device Coordination Group is composed of representatives of the Member States and chaired by a representative of the European Commission.

 

MDCG 2020-12

Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissues

Below the Guidance.

 

MDCG 2020-11

The guidance covers the activities carried out by the designating authorities under exceptional circumstances:
- renewal of designation under Directives 90/385/EEC and 93/42/EEC of notified bodies whose designation expires in the period from 26 May 2020 to 25 May 2021,
- surveillance activities to be performed by the designating authorities.

This guidance does not apply to the procedure for the initial designation of a notified body under the Directives 90/385/EEC and 93/42/EEC nor to the procedures for extensions of the scope of a notified body nor the removal of limitations on the scope of a notified body.

Below the Guidance.

MDCG 2020-11 - Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC - 29 May 2020

1814 Friday, 19 June 2020 15:45

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