{"id":18693,"date":"2021-08-04T09:27:17","date_gmt":"2021-08-04T07:27:17","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18693"},"modified":"2023-12-12T16:07:55","modified_gmt":"2023-12-12T15:07:55","slug":"eu-first-mdr-ivdr-harmonised-standards-published","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/08\/04\/eu-first-mdr-ivdr-harmonised-standards-published\/","title":{"rendered":"EU: first MDR and IVDR harmonised standards published"},"content":{"rendered":"\r\n

In July 2021, the first MDR <\/strong>and IVDR harmonised standards<\/strong> were published<\/strong> in the Official Journal of the European Union.<\/p>\r\n\r\n\r\n\r\n

Harmonised rules or<\/strong> \u201charmonised standards\u201d<\/strong> are European standards valid for all EU countries that are developed by a European Standardisation Body (ESO)<\/strong>, such as CEN, CENELEC, ETSI and adopted on the basis of a request from the European Commission for the purpose of applying Union legislation on harmonisation (Def. Article 2, point 1 (c) Regulation (EU) No 1025\/2012).<\/p>\r\n\r\n\r\n\r\n

These standards are therefore designed to help<\/strong> interested parties to interpret the safety requirements in order to achieve product conformity and enable the presumption of compliance<\/strong>.<\/p>\r\n\r\n\r\n\r\n

\"EU\r\n
First MDR and IVDR harmonised standards published<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n

First five MDR harmonised standards<\/strong><\/h2>\r\n\r\n\r\n\r\n

On 19 July 2021 the Implementing Decision (EU) 2021\/1182 of the Commission gathered on the 16th of July 2021 was published, regarding harmonised standards for medical devices drafted in support of MDR Regulations (EU) 2017\/745 by the European Parliament and by the Council.<\/p>\r\n\r\n\r\n\r\n

The paper presents the first five harmonised MDR standards<\/strong>:<\/p>\r\n\r\n\r\n\r\n

1.EN ISO 10993-23:2021<\/strong>
Biological evaluation of medical devices \u2013 Part 23: Tests for irritation (ISO 10993-23:2021).<\/p>\r\n\r\n\r\n\r\n

2.EN ISO 11135:2014 <\/strong>
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 11135:2014\/A1:2019<\/strong><\/p>\r\n\r\n\r\n\r\n

3.EN ISO 11137-1:2015 <\/strong>
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 11137-1:2015\/A2:2019<\/strong><\/p>\r\n\r\n\r\n\r\n

4.EN ISO 11737-2:2020 <\/strong>
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).<\/p>\r\n\r\n\r\n\r\n

5.EN ISO 25424:2019 <\/strong>
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).<\/p>\r\n\r\n\r\n\r\n

First four IVDR harmonised standards<\/strong><\/h2>\r\n\r\n\r\n\r\n

On 20 July 2021 the Implementing Decision (EU) 2021\/1195 of the Commission gathered on the 19th of July 2021 was published, regarding harmonised standards for in vitro diagnostic medical devices drafted in support of IVDR Regulations (EU) 2017\/746 by the European Parliament and Council.<\/p>\r\n\r\n\r\n\r\n

The document identifies the first four harmonised IVDR standards<\/strong>:<\/p>\r\n\r\n\r\n\r\n

EN ISO 11135:2014 <\/strong>
Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014).
EN ISO 11135:2014\/A1:2019<\/strong><\/p>\r\n\r\n\r\n\r\n

2.EN ISO 11137-1:2015<\/strong>
Sterilization of health care products \u2013 Radiation \u2013 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 11137-1:2015\/A2:2019<\/strong><\/p>\r\n\r\n\r\n\r\n

3.EN ISO 11737-2:2020<\/strong>
Sterilization of health care products \u2013 Microbiological methods \u2013 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019).<\/p>\r\n\r\n\r\n\r\n

4.EN ISO 25424:2019<\/strong>
Sterilization of health care products \u2013 Low temperature steam and formaldehyde \u2013 Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018).<\/p>\r\n\r\n\r\n\r\n

Do you always want to be up to date on the latest medical news and our activities?<\/strong><\/h2>\r\n\r\n\r\n\r\n

Subscribe to our newsletter<\/a> <\/strong>or contact us<\/strong><\/a>.<\/p>\r\n\r\n\r\n\r\n

Trust Thema! Discover our strategic-regulatory consulting services<\/a><\/strong>.<\/p>\r\n\r\n\r\n\r\n

Sources<\/em>:<\/p>\r\n\r\n\r\n\r\n

COMMISSION IMPLEMENTING DECISION (EU) 2021\/1182 of 16 July 2021 on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017\/745 of the European Parliament and of the Council<\/a><\/p>\r\n\r\n\r\n\r\n

COMMISSION IMPLEMENTING DECISION (EU) 2021\/1195 of 19 July 2021 on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017\/746 of the European Parliament and of the Council<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"

In July 2021, the first MDR and IVDR harmonised standards were published in the Official Journal of the European Union. 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