As new technologies are developed everyday, legislation needs to change according to it. In April 2017 a new regulation on medical devices was created. 

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Regulation (EU) 2017/745, also known as EU-MDR repeals the current MDD and AIMDD.  

 

Nowadays all three legislations are in force: the new one entered into force on 25 May 2017 and the latest will be no longer in force since 25 May 2020. During this period, all three legislations can be applied.

The main changes are among others: increased number of classification rules (from 18 to 22), more insight in the criteria for designating Notified Bodies, more importance on post-market surveillance (vigilance and traceability by introducing an “implant card”, for instance) and reinforcement on clinical evidence.

 

 

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In the same way, the IVD directive (98/79/EC) was repealed by the new EU-IVDR regulation which entered into force in May 2017. Until 26 May 2022 both regulations are valid, then the former will no longer be in force.

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Regulation (EU) 2017/746, also known as EU-IVDR. 

Major changes include: an expansion of the scope of the directive, a newer classification to four Classes of risk (from lowest to highest risk, classes from A to D) and documentation must be kept for 10 years (five more than currently) after the last placing on the market. The new risk-rule classification system will lead to a reduction of self-declared devices, meaning that the 80% of IVDs will require the participation of a Notified Body to obtain the CE mark.