Start the countdown to align with EU Medical Devices Regulations

Start the countdown to align with EU Medical Devices Regulations

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How do the new EU Regulations on medical devices impact Switzerland? What do they mean for Swiss medical device companies (manufacturers, importers, distributors)? What do we need to change? When do we need to be ready? Where do we get information and support?

The new EU regulations on medical devices entered into force in May 2017. Therefore, Swiss laws and ordinances on medical devices have to be adapted in order to continue trade with medical devices in Europe.

The Swiss authorities announced to incorporate the stricter regulations into Swiss laws and ordinances starting in November 2017 with the adaption of the Medical Devices Ordinance (MedDO). Medical device companies have to comply with the new ordinances until 2020 at the latest if they wish to keep trading in the European Union markets (learn more here https://www.swissmedic.ch/medizinprodukte/02636/03731/index.html?lang=en).

Medical Device companies will be then confronted with realizing the increased requirements:

  • A Responsible Person for medical devices will be needed
  • All products must be CE certificated according the new regulation from 2020 onwards. All products which have been certificated according to the old regulation during the transition period (2017 – 2020) will lose their certifications including the market authorization in 2024 at the latest
  • Market surveillance will be expanded
  • Additional periodic reports will be needed
  • More clinical studies have to be conducted
  • Complete traceability will be guaranteed (new labelling)
  • The classifications of medical devices will be changed and updated in new databases
  • Extension of the new laws and ordinances to products without medical intended purpose (supplies)

 

What you can do now to prepare yourself and your company:

  • Inform yourself and your colleagues about the new changes
  • Execute a gap analysis: what is missing (technical documentation, quality management)
  • Appoint an appropriate person as your Responsible Person to ensure implementation of these changes and  compliance with the new ordinances
  • Ensure that you apply for the CE certifications as soon as possible according to the new regulation, because all old certifications will automatically be invalid in 2024

 

Need help? Contact our Responsible Person Services:

www.responsible-person.ch or under Qualified-Person@morgansindall.ch

 

Our experts are there to support you to meet this challenge.