March 2024: New MDR/IVDR Harmonized Standards

Team Notified Body: New MDR Training (June) and Upcoming Webinar (March)

Switzerland-EU Mutual Recognition: New Negotiation Discussions Underway

Table of Contents

Overview

MDR: Eight standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024/815. The link is available: HERE

IVDR: Three standards have been newly harmonized. These fall under Commission Implementing Decision (EU) 2024/817. The link is available: HERE

Reference number of the standard	Title of the standard
EN 455-3:2023	Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
EN ISO 10993-15:2023	Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)
EN ISO 10993-17:2023	Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EN ISO 10993-18:2020 EN ISO 10993-18:2020/A1:2023	Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
EN ISO 11137-2:2015 EN ISO 11137-2:2015/A1:2023	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023	Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023	Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 17664-2:2023	Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)

Reference number of the standard	Title of the standard
EN ISO 11137-2:2015 EN ISO 11137-2:2015/A1:2023	Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023	Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023	Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)