On May 26, 2022, the In Vitro Diagnostics Regulation (IVDR) will become applicable.

The application date of the Medical Devices Regulation (MDR) was pushed back by one year due to the COVID-19 pandemic. Although the industry expected – or clung to hope – that the same would apply to the IVDR, the European Commission chose not to push back its application date. Instead, the two-year transition phase was extended by 1 to 3 years. This should give IVD makers more time to get their products certified under the renewed legislation.

Products covered by the scope of the IVDR, but not requiring the involvement of a notified body, must comply with IVDR requirements by May 26, 2022.

On January 4th of this year, the European Commission officially recognized nine harmonized standards for medical devices, including ISO 13485 (quality management system). Recognizing these standards, the European Commission indicates that medical device manufacturers/developers can use these standards to implement the Medical Devices Regulation (MDR). The nine recognized harmonized standards follow an earlier set of harmonized standards recognized by the European Commission in July 2021.

The following standards are currently recognized as harmonized, and thus deemed appropriate to implement the MDR requirements:

July 2021:

• EN ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)
• EN ISO 11135:2014 Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
• EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
• EN ISO 11737-2:2020 Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
• EN ISO 25424:2019 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)

January 2022

• 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 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 13408-6:2021 Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)
• EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
• 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 IEC 6061-2-83:2020 Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

Initially, the intention was to make the European medical device database EUDAMED available at the same time as the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) respectively become applicable. However, in the run-up to the application date of the MDR, it became apparent that they were jumping the gun regarding the launch of EUDAMED. As a result, the launch of the database was postponed until the IVDR’s application date: May 26, 2022.

Currently, some of EUDAMED’s modules are available , but a timeline has not yet been shared for the launch of other modules.

MDCG’s guidance provides further explanation of the requirements set forth in both the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). Several guidelines have already been published to date, and it appears that this trend will be continued this year.

The following MDCG guidelines are expected in 2022:

MDR

• Person Responsible for Regulatory Compliance guidance (update) – 2022
• Incident Reporting template form (new) – Q1 2022
• Post-Market Surveillance guidance (new) – Q2 2022
• Vigilance Q&A document (new) – Q3 2022

IVDR

• Performance Evaluation guidance (new) – 2022
• Summary of Safety & Performance template (new) – 2022
• In-house Devices guidance (new) – 2022
• ‘IVDR in context of hypothetical scenarios of an urgent response to a health crisis’ analysis (new) – 2022