| 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 |
| 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 | 19.07.2021 (MDR) 20.07.2021 (IVDR) | |||||
| 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 | 25.03.2020 (MDD) 25.03.2020 (IVDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) | 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 | 05.01.2022 (MDR) 07.01.2022 (IVDR) | |||||
| 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 | 25.03.2020 (AIMD) 25.03.2020 (MDD) 25.03.2020 (IVDD) 17.05.2022 (MDR) 07.01.2022 (IVDR) | 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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