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In vitro diagnostic medical devices (IVDR)...
| Abbreviation: | IVDR |
| Publications in the Official Journal: |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
| Notified bodies (NANDO): | Notified bodies for Regulation (EU) 2017/746 |
| ES/EU regulation | ČR regulation | SR regulation |
|---|---|---|
|
Regulation (EU) 2017/746
consolidated text 2023 |
Regulation (EU) 2017/746
consolidated text
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 Act No 375/2022 Sb. applicable from 22. 12. 2022 Decree No 377/2022 Sb. applicable from 22. 12. 2022 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
Regulation (EU)2017/746
consolidated text
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112 / Commission Implementing Regulation 2023/2713 (applicable from 1.10.2024) / Commission Implementing Regulation (EU)2022/1107 (applicable from 25. 7. 2024) / rules for the application of Regulation (EU)2017/746: (EU)2022/944, (EU)2022/945 |
| Standard code | ČSN | Description | Applicability date | Date of cessation of presumption of conformity of superseded standard | Publications in the Official Journal | Regulations |
|---|---|---|---|---|---|---|
| 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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
(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 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 | 08.03.2024 (IVDR) 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 08.03.2024 (MDR) | 30.06.2016 (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
(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 |
| 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 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 | 08.03.2024 (IVDR) 15.04.2021 (MDD) 15.04.2021 (AIMD) 15.04.2021 (IVDD) 08.03.2024 (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
(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 | |
| 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 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 | 08.03.2024 (IVDR) 15.04.2021 (MDD) 15.04.2021 (AIMD) 15.04.2021 (IVDD) 08.03.2024 (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
(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 | |
| 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) |
(EU)2021/1182 (hEN 19. 7. 2021) with amendments: (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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) |
(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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (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) | ||||
| 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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(EU)2017/745 (EU)2017/746 | |
| A11:2021 | 12.05.2022 (IVDR) 17.05.2022 (MDR) | |||||
| 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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(EU)2017/745 (EU)2017/746 | |
| EN ISO 17511:2021 | ČSN EN ISO 17511 ed. 2:2021 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples | 07.01.2022 (IVDR) |
(EU)2021/1195 (hEN 20. 7. 2021) without amendments: |
(EU)2017/746 | |
| 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)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 with amendment (EU)2023/1410 Summary list hEN for information purposes only (8. 3. 2024) (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) |
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