| Abbreviation: | MDR |
| Publications in the Official Journal: |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU)2017/745 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Regulation (EU)2017/745
consolidated text with amendment No (EU)2023/502 and amendment No (EU)2023/607
/ amendment No (EU)2023/607 applicable from 20. 3. 2023 / amendment No (EU)2023/502 applicable from 11. 3. 2023 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 / Commission Implementig Regulation No (EU)2021/2226 / Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text with amendment No (EU)2023/502 and amendment No (EU)2023/607
/ amendment No (EU)2023/607 applicable from 20. 3. 2023 / amendment No (EU)2023/502 applicable from 11. 3. 2023 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 / Commission Implementig Regulation No (EU)2021/2226 / Commission Implementig Regulation No (EU)2021/2078 |
Regulation (EU)2017/745
consolidated text with amendment No (EU)2023/502 and amendment No (EU)2023/607
/ amendment No (EU)2023/607 applicable from 20. 3. 2023 / amendment No (EU)2023/502 applicable from 11. 3. 2023 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 / 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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(EU)2017/745 | |
| EN ISO 10993-23:2021 | ČSN EN ISO 10993-23 | Biologické hodnocení zdravotnických prostředků - Část 23: Zkoušky na dráždivost | 19.07.2021 (MDR) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(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 | 20.07.2021 (IVDR) 13.05.2016 (MDD) 13.05.2016 (AIMD) 17.11.2017 (IVDD) 19.07.2021 (MDR) | 30.09.2021 (MDD) 30.06.2016 (AIMD) 30.06.2016 (IVDD) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 (EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(EU)2017/746 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 |
| A2:2019 | 20.07.2021 (IVDR) 25.03.2020 (MDD) 25.03.2020 (IVDD) 19.07.2021 (MDR) | 30.09.2021 (IVDD) | ||||
| 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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(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 | 20.07.2021 (IVDR) 15.04.2021 (MDD) 15.04.2021 (AIMD) 15.04.2021 (IVDD) 19.07.2021 (MDR) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 (EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(EU)2017/746 93/42/EHS 54/2015 Sb. 166/2020 Z.z. 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 98/79/ES 569/2001 Z.z. 56/2015 Sb. (EU)2017/745 | |
| 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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(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) |
(EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2020/439 (hEN 25. 3. 2020) amendment: (EU)2021/609 (hEN 15. 4.2021) / consolidated text (EU)2020/439 2017/C/389/4 (EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
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 (MDD) 25.03.2020 (AIMD) 25.03.2020 (IVDD) 17.05.2022 (MDR) | 30.09.2021 (MDD) 30.09.2021 (AIMD) 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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(EU)2017/745 | |
| EN ISO 14971:2019 | ČSN EN ISO 14971:2020Změna A11-6.22 | Medical devices - Application of risk management to medical devices | 17.05.2022 (MDR) 12.05.2022 (IVDR) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(EU)2017/745 (EU)2017/746 | |
| A11:2021 | 17.05.2022 (MDR) 12.05.2022 (IVDR) | |||||
| EN ISO 15223-1:2021 | ČSN EN ISO 15223-1:2022 | Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements | 05.01.2022 (MDR) 07.01.2022 (IVDR) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(EU)2017/745 (EU)2017/746 | |
| EN ISO 17664-1:2021 | ČSN EN ISO 17664-1 připravuje se | 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) | 05.01.2022 (MDR) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) |
(EU)2017/745 | |
| EN ISO 25424:2019 | ČSN EN ISO 25424:2020Změna A1-12.22 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices | 25.03.2020 (AIMD) 25.03.2020 (MDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) |
(EU)2020/438 (hEN 25. 3. 2020) amendment: (EU)2021/611 (hEN 15. 4. 2021) / consolidated text (EU)2020/438 2017/C/389/2 (EU)2020/437 (hEN 25. 3. 2020) with amendment (EU)2021/610 (hEN 15. 4. 2021) / consolidate text (EU)2020/437 2017/C/389/3 (EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (5. 7. 2023) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. (EU)2017/745 (EU)2017/746 | |
| A1:2022 | 05.07.2023 (MDR) 05.07.2023 (IVDR) |
?scId=227