Kategorie: Medical devices
Legal regulation of health-targeted products advertising
As we informed you in earlier articles and posts, starting from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (hereinafter the “MDR”) will …
Read moreMDR postponed for one year
As we informed you earlier in our article, new EU legislation fundamentally regulating the field of medical devices was to enter into force on 26 May 2020, namely Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation …
Read moreTransformation of the Czech medical devices laws
With regard to the adoption and forthcoming application of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (“MDR”) and Regulation (EU) 2017/746 of the European Parliament and of the Council on diagnostic medical devices in vitro (“IVDR”), the Czech legislation in the field of medical devices is likely to …
Read moreMedical devices in the light of the new legislation – last year for preparation
Similarly as recently in the case of medical products, when on 9 February 2019 came into effect Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human …
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