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Sector of: In vitro diagnostic medical devices (IVDR)

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

Abbreviation: IVDR
Publications in the Official Journal:

(EU)2021/1195 (hEN 20. 7. 2021)
Amendments (EU)2021/1195:

(EU)2026/2481 (hEN 10. 11. 2026)
(EU)2026/1313 (hEN 17. 6. 2026)
(EU)2025/679 (hEN 10. 4. 2025)
(EU)2024/2625 (hEN 9. 10. 2024)
(EU)2024/817 (hEN 8. 3. 2024)
(EU)2023/1411 (hEN 5. 7. 2023)
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ consolidated text (EU)2021/1195
/ Summary list hEN for information purposes only 
Notified bodies (NANDO): Notified bodies for Regulation (EU) 2017/746
ES/EU regulation ČR regulation SR regulation
Regulation (EU) 2017/746

consolidated text 10. 1. 2025 pdf format
/ amendment (EU)2026/977 shall apply from 25. 2. 2027; exceptions under Article 4(4) shall apply from 1. 2. 2028.
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024)

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
/ quality management requirements (EU)2026/977 applicable from 25. 2. 2027 Article 4(4) applicable from 1. 1. 2028

 		Regulation (EU) 2017/746
consolidated text 10. 1. 2025 pdf format
/ amendment (EU)2026/977 shall apply from 25. 2. 2027; exceptions under Article 4(4) shall apply from 1. 2. 2028.
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024)

/ 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
/ amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024
Decree No 377/2022 Sb. applicable from 22. 12. 2022 - amendments 166/2026 Sb. (applicable from 16. 9. 2026)
/ 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
/ quality management requirements (EU)2026/977 applicable from 25. 2. 2027 Article 4(4) applicable from 1. 1. 2028
 		Regulation (EU)2017/746
consolidated text 10. 1. 2025 pdf format
/ amendment (EU)2026/977 shall apply from 25. 2. 2027; exceptions under Article 4(4) shall apply from 1. 2. 2028.
/ amendment (EU)2024/1860 (applicable from 9. 7. 2024)

/ 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
/ quality management requirements (EU)2026/977 applicable from 25. 2. 2027 Article 4(4) applicable from 1. 1. 2028
108/2024 Z.z.
1. 7. 2024 cancels the Act No 250/2007 Z.z.
Act No 281/2023 Z.z. repealed by 83/2025 Z. z.
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 556-1:2024 ČSN EN 556-1:2025 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices 09.04.2025 (MDR) 10.04.2025 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746 108/2024 Z.z.
EN 556-2:2024 ČSN EN 556-2:2025 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices 09.04.2025 (MDR) 24.05.2025 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
A1:2019     19.07.2021 (MDR) 20.07.2021 (IVDR)    
EN ISO 11137-1:2015 replaces EN ISO 11137-1:2006Canceled EN ISO 11137-1:2026Concurrent ČSN EN ISO 11137-1:2016Změna A2-5.20(Canceled (still harmonized)) is replaced ČSN EN ISO 11137-1:2026Concurrent 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)2017/746 108/2024 Z.z.
A2:2019     25.03.2020 (MDD) 25.03.2020 (IVDD) 19.07.2021 (MDR) 20.07.2021 (IVDR) 30.09.2021 (IVDD)    
EN ISO 11137-1:2026 Concurrent concurrent validity with EN ISO 11137-1:2015 ČSN EN ISO 11137-1:2026(Concurrent) concurrent validity with ČSN EN ISO 11137-1:2016Změna A2-5.20Canceled (still harmonized) Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025) 10.11.2026 (MDR) 10.11.2026 (IVDR) 10.05.2028 (MDR) 10.05.2028 (IVDR) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)2017/746 108/2024 Z.z.
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)    
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) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746 108/2024 Z.z.
A11:2021     17.05.2022 (MDR) 12.05.2022 (IVDR)    
EN ISO 15223-1:2021 ČSN EN ISO 15223-1:2022Změna A1-6.26 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) OJ-MDR , OJ-IVDR (EU)2017/745 (EU)2017/746 108/2024 Z.z.
A1:2025        
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) OJ-IVDR (EU)2017/746 108/2024 Z.z.
EN ISO 20916:2024 ČSN EN ISO 20916:2024 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice 09.10.2024 (IVDR) OJ-IVDR (EU)2017/746 108/2024 Z.z.
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) OJ-AIMD , OJ-MDD , OJ-MDR , OJ-IVDR 55/2015 Sb. 167/2020 Z.z. 90/385/EHS 93/42/EHS 54/2015 Sb. 166/2020 Z.z. (EU)2017/745 (EU)2017/746 108/2024 Z.z.
A1:2022     05.07.2023 (MDR) 05.07.2023 (IVDR)    
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