Switzerland is already part way through transitioning to its own regulations due to the breakdown in its mutual recognition agreement with the EU at the end of May 2021.

The impact of the breakdown of the MRA is that Swiss manufacturers are now regarded as third-country companies in the EU. This means that Swiss manufacturers and those manufacturers who used Swiss notified bodies or authorized representatives must, therefore, have new certificates issued by EU notified bodies and have an authorized representative in an EU country.

In an update to the Swiss Medical Device Ordinance (MedDO), the Swiss equivalent of the EU Medical Device Regulation, published one week before the EU MDR was implemented on 26 May, three transition period deadlines were set for Swiss imports of CE-marked and labeled devices:

  • 31 December 2021 for class III devices;
  • 31 March 2022 for class II devices; and
  • 31 July 2022 for class I devices.

After these dates, the continued export of devices into Switzerland by foreign manufacturers will be subject to their appointment of a local Swiss-based authorized representative (CH-REP), or use of their own local company in Switzerland, should they have one. This will necessitate product label changes.

Neither the UK nor Switzerland have access to, nor are part of, the Eudamed medical devices database.

QNET is in processing to open an local office in Switzerland to provide CH-REP services. Contact our office for more information.

Amending Implementing Decision (EU) 2021/1182 regards harmonized standards for the biological evaluation of medical devices, sterilization of health care products, aseptic processing of health care products, quality management systems, symbols to be used with information to be supplied by the manufacturer, processing of health care products and home light therapy equipment. See table.

Standard

Title

EN ISO 13485:2016/ A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/A11:2021

EN ISO 10993-23:2021

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

EN ISO 10993-9:2021

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

EN ISO 10993-12:2021

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

EN ISO 13408-6:2021

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

EN ISO 14160:2021

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)

EN ISO 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

EN ISO 17664-1:2021

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

EN ISO 11737-1:2018

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) EN ISO 11737-1:2018/A1:2021

EN IEC 60601-2-83:2020

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment EN IEC 60601-2-83:2020/A11:2021.

EN ISO 17511:2021

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

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