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EN ISO 14971:2012

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

Status:	Harmonized EN ISO 14971:2012 replaces EN ISO 14971:2009 (Canceled)
Poznámka:

Full text EAD:
Sector of EN ISO 14971:2012:	AIMD \| Active implantable medical devices (placed on the market to 26. 5. 2021) MDD \| Medical devices (placed on the market to 26. 5. 2021) IVDD \| In vitro diagnostic medical devices (placed on the market to 26. 5. 2022)
Sphere of EN ISO 14971:2012:	Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere Regulation No. 22/1997 Sb. - harmonized sphere
Publications in the Official Journal:	(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
Notified bodies (NANDO):	Notified bodies for Council directive 90/385/EEC Notified bodies for Council Directive 93/42/EEC Notified bodies for Directive EP and Council 98/79/EC

ES/EU regulation	ČR regulation	SR regulation
	nařízení vlády č. 55/2015 Sb. repealed by 89/2021 Coll. from 26th May 2021
		Government Regulation SR No 167/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.
Council directive 90/385/EEC /repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Commission implementing decision No (EU)2019/1396 / Commission decision No 2010/227/EU / Regulation Commission No 207/2012 repealed by Commission Implementing Regulation No (EU)2021/2226 (partial repeal 4. 1. 2022, repeal 26. 5. 2024) / Regulation Commission No 722/2012
Council Directive 93/42/EEC / repealed by Regulation of the European Parliament and of the Council (EU)2017/745 consolidated text without amendment (EU)2023/2197 / amendment (EU)2023/2197 applicable from 9. 11. 2025 / 2020/C/171/1 - Guidelines on the adoption of derogations / Recommendations (EU)2021/1433 wiil gradually expire Recommendations (EU)2020/403 / Recommendations (EU)2020/403 without Corrigendum / Commission implementing decision No (EU)2019/1396 / Commission Desicion No (EU)2018/1617 / Commission Implementing regulation No (EU)2017/2185 / Regulation Commission No 722/2012 / Commission Desicion No 2010/227/EU / Agreement No 2017/2118
	nařízení vlády č. 54/2015 Sb. repealed by 89/2021 Coll. from 26th May 2021
		Government Regulation SR No 166/2020 Z.z. // 25. 5. 2021 repealed by No 362/2011 Coll.
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 with amendment (EU)2024/1860 / 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. / amendment by Act. No 241/2024 Coll. applicable from 23. 8. 2024 Decree No 377/2022 Coll.

Co-existence period end date:	30.08.2012 (AIMD) 30.08.2012 (MDD) 30.08.2012 (IVDD)
Released:	August, 2012

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