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Sector of: In vitro diagnostic medical devices

Sphere of: Regulation No. 22/1997 Sb. - harmonized sphere

Abbreviation: IVDD
Publications in the Official Journal: (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
Notified bodies (NANDO): Notified bodies for Directive EP and Council 98/79/EC
ES/EU regulation ČR regulation SR regulation
Directive EP and Council 98/79/EC / will be partial repealed by Regulation (EU)2017/746  of the European Parliament and of the Council (text withamendment (EU)2023/607
/ Commission Implementing regulation No (EU)2017/2185
/ Commission Decision No 2008/932/ES, 2010/227/EC
nariadenie vlády SR č. 569/2001 Z.z. (consolidated text)
nařízení vlády č. 56/2015 Sb. repealed by Law No 375/2022 Coll.

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Standard code ČSN Description Applicability date Date of cessation of presumption of conformity of superseded standard Publications in the Official Journal Regulations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 556-1:2001 replaces EN 556:1994 + A1:1998Canceled ČSN EN 556-1:2002Oprava 1-1.07 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices 15.11.2006 (MDD) 15.11.2006 (AIMD) 15.11.2006 (IVDD) 30.04.2002 (MDD) 30.04.2002 (AIMD) 30.04.2002 (IVDD) (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)2020/438 (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
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.
AC:2006        
EN 556-2:2015 replaces EN 556-2:2003Canceled ČSN EN 556-2:2016 replaces ČSN EN 556-2:2004Canceled Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 30.06.2016 (MDD) 30.06.2016 (AIMD) 30.06.2016 (IVDD) (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)2020/438 (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
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.
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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)2020/438 (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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)2020/438 (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 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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)2020/438 (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 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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)2020/438 (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 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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

(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)2020/438 (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 12322:1999 ČSN EN 12322:2000Změna A1-7.02 In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media 31.07.2002 (IVDD) 30.04.2002 (IVDD) (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
98/79/ES 569/2001 Z.z. 56/2015 Sb.
A1:2001        
EN ISO 13408-1:2015 replaces EN ISO 13408-1:2011Canceled ČSN EN ISO 13408-1:2016 replaces ČSN EN ISO 13408-1:2011Změna A1-12.13Canceled Aseptic processing of health care products - Part 1: General requirements 13.05.2016 (MDD) 13.05.2016 (AIMD) 13.05.2016 (IVDD) 30.06.2016 (MDD) 30.06.2016 (AIMD) 30.06.2016 (IVDD) (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)2020/438 (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
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.
EN ISO 13408-2:2018 replaces EN ISO 13408-2:2011Canceled ČSN EN ISO 13408-2:2018 replaces ČSN EN ISO 13408-2:2011Canceled Aseptic processing of health care products - Part 2: Sterilizing filtration 25.03.2020 (AIMD) 25.03.2020 (MDD) 25.03.2020 (IVDD) 30.09.2021 (AIMD) 30.09.2021 (MDD) 30.09.2021 (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
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.
EN ISO 13408-3:2011 replaces EN 13824:2004Canceled ČSN EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) 19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD) 31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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
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.
EN ISO 13408-4:2011 replaces EN 13824:2004Canceled ČSN EN ISO 13408-4:2012 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) 19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD) 31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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
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.
EN ISO 13408-5:2011 replaces EN 13824:2004Canceled ČSN EN ISO 13408-5:2012 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) 19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD) 31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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
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.
EN ISO 13408-6:2011 replaces EN 13824:2004Canceled ČSN EN ISO 13408-6:2012Změna A1-9.13 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) 19.08.2011 (AIMD) 19.08.2011 (MDD) 19.08.2011 (IVDD) 31.12.2011 (AIMD) 31.12.2011 (MDD) 31.12.2011 (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
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.
EN ISO 13408-7:2015 ČSN EN ISO 13408-7:2016 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products 13.05.2016 (AIMD) 13.05.2016 (MDD) 13.05.2016 (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
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.
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:
(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 with amendment (EU)2023/1411
/ Summary list hEN for information purposes only (8. 3. 2024)

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 13532:2002 ČSN EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing 17.12.2002 (IVDD) (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
98/79/ES 569/2001 Z.z. 56/2015 Sb.
EN 13612:2002 ČSN EN 13612:2002Oprava 1-7.03 Performance evaluation of in vitro diagnostic medical devices 02.12.2009 (IVDD) (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
98/79/ES 569/2001 Z.z. 56/2015 Sb.
AC:2002        
EN 13641:2002 ČSN EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents 17.12.2002 (IVDD) (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
98/79/ES 569/2001 Z.z. 56/2015 Sb.
EN 13975:2003 ČSN EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects 21.11.2003 (IVDD) (EU)2020/439 (hEN 25. 3. 2020) 
amendment: (EU)2021/609 (hEN 15. 4.2021)
/ consolidated text (EU)2020/439
2017/C/389/4
98/79/ES 569/2001 Z.z. 56/2015 Sb.
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