Proposal to amend Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices - Related Opinions

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Medicinal products for human and investigational use / Derogations

Приети on 23/02/2022
Референтен номер: 
INT/975-EESC-2022-2022-00378
Referral: 
COM(2021) 997 final 2021/0431 CODCOM(2021) 998 final 2021/0432 COD
Rapporteur: 
Martin SCHAFFENRATH (Austria)
Пленарна сесия: 
567 -
Feb 23, 2022 Feb 24, 2022

The EESC:

  • welcomes this package of measures;
  • recognises that need to pay particular attention to the situation of smaller EU Member States, Cyprus, Ireland and Malta in particula;
  • stresses in particular the central role of a functioning, fair and efficient internal market;
  • welcomes the packaging requirements for UK products included in the package;
  • draws attention to the need for a timely and sustainable solution, which should be developed within the framework of the European Pharmaceutical Strategy.

 

Становище на ЕИСК: Medicinal products for human and investigational use / Derogations

In vitro diagnostic medical devices

Приети on 08/12/2021
Референтен номер: 
INT/970-EESC-2021
Referral: 
COM(2021) 627 final 2021/0323 COD
General Rapporteur: 
Christophe LEFÈVRE (Workers - GR II)

The Commission proposal amends Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.

Становище на ЕИСК: In vitro diagnostic medical devices

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