In this video the top 3 general differences and improvements between the MDR and the previous Directives related to clinical investigations are given.
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Transcript:
In today’s video I’m going to answers the following question:
“What are the general differences and improvements related to clinical investigations under the MDR as compared to the previous Directives?”
This is not a question that is quickly answered but let me give you 3 general differences.
The first difference is regarding the type of the law.
A Directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries how to reach these goals by the implementation of national laws.
A Regulation, as opposed to a Directive, is a binding legislative act that must be applied in its entirety across the EU on the date of application. It means that the rules are applied in an identical manner throughout the EU. Member States, in authorising and supervising the conduct of a clinical investigation, will be required to base their assessments and decisions on the same rules.
Another difference is that the MDR contains greater detail than the Directives, which is a result of implementing aspects related to good clinical practice, many of which have previously been presented in the form of guidance and standard documents.
Further, harmonization at European level will provide greater certainty, which will support an environment that provides greater predictability and is more favourable for conducting clinical investigations, with the highest standards of patient safety, for all EU Member States. It will not only harmonise decisions, but also foster work sharing and collaboration between Member States and enhance the transparency regarding these studies.
More information on the harmonization is given in our upcoming article, so stay tuned.
