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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) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

Notified bodies (NANDO): Notified bodies for Regulation (EU) 2017/746
ES/EU regulation ČR regulation SR regulation
Regulation (EU) 2017/746

text with amendment No (EU)2022/112
applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112
/ 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
text with amendment No (EU)2022/112
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112
/ 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
text with amendment No (EU)2022/112
/ applicable from from 26th May 2022, cancels and partial replaces the Directive No 98/79/EC, exceptions viz Article 112
/ 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
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Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations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 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(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 A1-3.14(Canceled) 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) (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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

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     19.07.2021 (MDR) 25.03.2020 (MDD) 25.03.2020 (IVDD) 20.07.2021 (IVDR) 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(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 11737-2:2010(Canceled) 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) (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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

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 13408-6:2021 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(EU)2017/745 (EU)2017/746
EN ISO 13485:2016 replaces EN ISO 13485:2012Canceled ČSN EN ISO 13485 ed. 2:2016Oprava 1-7.17A1:2021 připravuje se replaces ČSN EN ISO 13485:2012Oprava 1-1.13Oprava 2-1.13Změna Z1-12.16(Canceled) 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

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     17.05.2022 (MDR) 25.03.2020 (MDD) 25.03.2020 (AIMD) 25.03.2020 (IVDD) 07.01.2022 (IVDR) 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(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)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

(EU)2017/746
EN ISO 25424:2019 ČSN EN ISO 25424:2020 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)2022/757 (hEN 17. 5. 2022)
(EU)2022/6 (hEN 5. 1. 2022)
/ consolidated text (EU)2021/1182
Summary list hEN for information purposes only (17. 5. 2022)

(EU)2021/1195 (hEN 20. 7. 2021) without amendments:
(EU)2022/729 (hEN 12. 5. 2022)
(EU)2022/15 (hEN 7. 1. 2022)
/ Summary list hEN for information purposes only (12. 5. 2022)
/ consolidated text (EU)2021/1195

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
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