News about GMP/cGMP

17.04.2020

MDR and ICH Q12: Switzerland's adaptation to the EU

How is Switzerland adapting to the EU regarding the implementation of MDR, IVDR and ICH Q12?
 

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

In Switzerland, medical devices are subject to the regulations for the European internal market. This resulted in the adaptation of Swiss law.

As the MDR and IVDR will not enter into force as planned on 26 May 2020 due to the Covid 19 crisis (we reported), the effects on the revision of Swiss medical device law are currently being examined. This is expected to become valid one year later than planned, provided that the introduction of the MDR is now postponed until May 2021.

In line with EU regulations, Switzerland has already adapted the following laws:

  • Therapeutic Products Act (HMG)
  • Human Research Act (HFG)
  • Medical Device Ordinance (MepV)

A regulation for in-vitro diagnostics (IvDV) is to follow in 2022. The revised Medical Devices Ordinance (MepV) and the new Ordinance on Clinical Trials with Medical Devices (KlinV-Mep) are to come into force at the same time as the EU regulations.

 

ICH Guideline Q12 – Technical and regulatory considerations for pharmaceutical lifecyle management

Switzerland also follows the EMA in implementing this guideline (we reported). According to the Committee for Medicinal Products for Human Use (CHMP), restrictions in the full adoption of ICH Q12 mainly concern the definitions of the following terms:

  • "established conditions": currently follows the EU Variations Guideline
  • "PLCM" (Product Life Cycle Management Document): currently not recognised in the EU

Swissmedic will apply ICH Q12, with the restrictions mentioned above, to all applications submitted from 1 April 2020 onwards. 


Quellen:

Swissmedic: Implementation of the new medical devices regulations – update

Swissmedic: ICH Guideline Q12: Implementation in Switzerland



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