The exercise of the power to adopt delegated acts conferred on the EC pursuant to Regulation (EU) 2017/745 on MD and Regulation (EU) 017/746 on in vitro diagnostic MD. The objective of this update is for sound functioning of regulatory framework for medical devices under IVDR. Medical devices and in vitro diagnostic medical devices have a essential role in saving lives by means of presenting healthcare answers for the diagnosis, prevention, monitoring, prediction, diagnosis, treatment. EU regulation 2017/745 and (EU) 2017/746 purpose to offer a robust, obvious and sustainable regulatory framework in order to ensure safety and performance of medical devices and in vitro diagnostic medical devices. EU regulation 2017/745 of the European Parliament and of the Council on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation (EU) 2017/745 applies since 26 May 2021. Regulation (EU) 2017/746 will apply from 26 May 2022.
EU Regulation
EU regulation 2017/745 and (EU) 2017/746 empower the commission to adopt numerous delegated acts. The commission is required to report to the EU parliament and the council at the delegations of power now not later than 9 months before the end of the five year. Officials said that an extension is wanted due to the fact flexibility might be required as technology advances and experience of the rule increases.
It is important to maintain the necessary flexibility in the legal framework, to supplement or adjust it to technical and scientific developments with a view to protect health and safety of patients, users and public health in general based also on more experience gained with the application of the Regulations. we are medical device regulatory consultant, who assist clients for regulatory services .
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References:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022DC0182
