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Sector of: Medical devices (NLF)

Sphere of: Regulation No. 90/2016 - harmonized sphere (NLF)

Abbreviation: MDR
Publications in the Official Journal: (EU)2021/1182 (hEN 19. 7. 2021)
Amendments (EU)2021/1182:
(EU)2024/2631 (hEN 9. 10. 2024)
(EU)2024/815 (hEN 8. 3. 2024)
(EU)2023/1410 (hEN 5. 7. 2023)
(EU)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182 without amendment (EU)2024/2631
Summary list hEN for information purposes only (9. 10. 2024)
Notified bodies (NANDO): Notified bodies for Regulation (EU)2017/745
ES/EU regulation ČR regulation SR regulation
Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
amendment (EU)2024/1860 (applicable from 9. 7. 2024)
/ amendment (EU)2023/2197 applicable from 9. 11. 2025
/ amendment (EU)2024/568 applicable from 1. 1. 2025
/ applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC,  exceptions viz Article 122
/ Commission Implementig Regulation No (EU)2022/2347
/ Commission Implementig Regulation No (EU)2022/2346 consolidated text with amendment No (EU)2023/1194
Rules for the application of Regulation (EU) 2017/745:
Commission Implementig Regulation No (EU)2021/2226
Commission Implementig Regulation No (EU)2021/2078

Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
amendment (EU)2024/1860
/ amendment (EU)2023/2197 applicable from 9. 11. 2025
/ amendment (EU)2024/568 applicable from 1. 1. 2025
/ applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC,  exceptions viz Article 122
Law No 375/2022 Coll.
/ amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024
/ Commission Implementig Regulation No (EU)2022/2347
/ Commission Implementig Regulation No (EU)2022/2346
consolidated text with amendment No (EU)2023/1194
Rules for the application of Regulation (EU) 2017/745:
Commission Implementig Regulation No (EU)2021/2226
Commission Implementig Regulation No (EU)2021/2078
Regulation (EU)2017/745
consolidated text without amendments (EU)2023/2197, (EU)2024/568
amendment (EU)2024/1860
/ amendment (EU)2023/2197 applicable from 9. 11. 2025
/ amendment (EU)2024/568 applicable from 1. 1. 2025
/ applicable from from 26th May 2021 (amendment dates of application by Regulation No (EU)2020/561), cancels and partial replaces the Directive No 93/42/EEC,  exceptions viz Article 122
/ Commission Implementig Regulation No (EU)2022/2347
/ Commission Implementig Regulation No (EU)2022/2346
consolidated text with amendment No (EU)2023/1194
Rules for the application of Regulation (EU) 2017/745:
Commission Implementig Regulation No (EU)2021/2226
Commission Implementig Regulation No (EU)2021/2078
Sector (abbr.) hEN:
Sphere:
Status:   Regulation:
Name/code Advanced search
Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations
EN 285:2015+A1:2021 ČSN EN 285+A1:2022 Sterilization - Steam sterilizers - Large sterilizers 17.05.2022 (MDR) OJ-MDR (EU)2017/745
EN 455-3:2023 EN 455-3.....připravuje se Medical gloves for single use - Part 3: Requirements and testing for biological evaluation 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-9:2021 ČSN EN ISO 10993-9:2022 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 05.01.2022 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-10:2023 ČSN EN ISO 10993-10 připravuje se.... Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization 05.07.2023 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-12:2021 ČSN EN ISO 10993-12:2022 Kat. čís.: 91987 Biologické hodnocení zdravotnických prostředků - Část 12: Příprava vzorků a referenční materiály Biological evaluation of medical devices Part 12: Sample preparation and reference materials 05.01.2022 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-15:2023 ČSN EN ISO 10993-15:2023 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-17:2023 ČSN EN ISO 10993-17....připravuje se Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances 08.03.2024 (MDR) OJ-MDR (EU)2017/745
EN ISO 10993-18:2020 replaces EN ISO 10993-18:2009Canceled ČSN EN ISO 10993-18:2020Změna A1-1.24 replaces ČSN EN ISO 10993-18:2009Canceled Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process 15.04.2021 (AIMD) 15.04.2021 (MDD) 08.03.2024 (MDR) OJ-AIMD , OJ-MDD , OJ-MDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. (EU)2017/745
A1:2023     08.03.2024 (MDR)    
EN ISO 10993-23:2021 ČSN EN ISO 10993-23 Biologické hodnocení zdravotnických prostředků - Část 23: Zkoušky na dráždivost 19.07.2021 (MDR) OJ-MDR (EU)2017/745
EN ISO 11135:2014 ČSN EN ISO 11135:2015Změna A1-5.20 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices 19.07.2021 (MDR) 20.07.2021 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746
A1:2019     20.07.2021 (IVDR) 19.07.2021 (MDR)    
EN ISO 11137-1:2015 replaces EN ISO 11137-1:2006Canceled ČSN EN ISO 11137-1:2016 replaces ČSN EN ISO 11137-1:2007Změna A1-3.14Canceled Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 13.05.2016 (AIMD) 13.05.2016 (MDD) 17.11.2017 (IVDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) 30.06.2016 (AIMD) 30.09.2021 (MDD) 30.06.2016 (IVDD) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
A2:2019     20.07.2021 (IVDR) 25.03.2020 (MDD) 25.03.2020 (IVDD) 19.07.2021 (MDR) 30.09.2021 (IVDD)    
EN ISO 11137-2:2015 replaces EN ISO 11137-2:2013Canceled ČSN EN ISO 11137-2:2016Změna A1-11.23 replaces ČSN EN ISO 11137-2:2014Canceled Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose 13.05.2016 (AIMD) 13.05.2016 (MDD) 13.05.2016 (IVDD) 08.03.2024 (MDR) 08.03.2024 (IVDR) 30.06.2016 (AIMD) 30.06.2016 (MDD) 30.06.2016 (IVDD) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
A1:2023     08.03.2024 (MDR) 08.03.2024 (IVDR)    
EN ISO 11607-1:2020 replaces EN ISO 11607-1:2009Canceled ČSN EN ISO 11607-1:2020Změna A1-5.24Změna A11-12.22 replaces ČSN EN ISO 11607-1:2010Změna A1-1.15Canceled Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems 15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (IVDR) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
A1:2023     08.03.2024 (MDR) 08.03.2024 (IVDR)    
EN ISO 11607-2:2020 replaces EN ISO 11607-2:2006Canceled ČSN EN ISO 11607-2:2020Změna A1-5.24Změna A11-12.22 replaces ČSN EN ISO 11607-2:2006Změna A1-1.15Canceled Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes 15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 08.03.2024 (MDR) 08.03.2024 (IVDR) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
A1:2023     08.03.2024 (MDR) 08.03.2024 (IVDR)    
EN ISO 11737-1:2018 ČSN EN ISO 11737-1:2018Změna A1-12.21Oprava 1-5.22 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products 05.01.2022 (MDR) 07.01.2022 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746
A1:2021     07.01.2022 (IVDR) 05.01.2022 (MDR)    
EN ISO 11737-2:2020 replaces EN ISO 11737-2:2009Canceled ČSN EN ISO 11737-2:2020 replaces ČSN EN ISO 11737-2:2010Canceled Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process 15.04.2021 (AIMD) 15.04.2021 (MDD) 15.04.2021 (IVDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
EN ISO 13408-1:2024 ČSN EN ISO 13408-1:2024 Aseptic processing of health care products - Part 1: General requirements 09.10.2024 (MDR) 09.10.2024 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746
EN ISO 13408-6:2021 ČSN EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems 05.01.2022 (MDR) 07.01.2022 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746
EN ISO 13485:2016 replaces EN ISO 13485:2012Canceled ČSN EN ISO 13485 ed. 2:2016Změna A11-4.22Oprava 1-7.17 replaces ČSN EN ISO 13485:2012Oprava 1-1.13Oprava 2-1.13Změna Z1-12.16Canceled Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) 17.11.2017 (AIMD) 17.11.2017 (MDD) 17.11.2017 (IVDD) 05.01.2022 (MDR) 07.01.2022 (IVDR) 31.03.2019 (AIMD) 31.03.2019 (MDD) 31.03.2019 (IVDD) OJ-AIMD , OJ-MDD , OJ-IVDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 (EU)2017/746
AC:2018     07.01.2022 (IVDR) 25.03.2020 (AIMD) 25.03.2020 (MDD) 25.03.2020 (IVDD) 17.05.2022 (MDR) 30.09.2021 (AIMD) 30.09.2021 (MDD) 30.09.2021 (IVDD)    
A11:2021     05.01.2022 (MDR)    
EN ISO 14160:2021 ČSN EN ISO 14160:2022 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 05.01.2022 (MDR) OJ-MDR (EU)2017/745
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