The new medical device regulation is finally here! What are the main changes? Special focus on substance-based medical device
ALESSANDRA IAVELLO1, IRENE GIOVANETTO2
1. Head of BU Medical Device, ChemSafe
2. ChemSafe
Abstract
The date of application of Medical Device Regulation 2017/745 is finally over, but the gaps are not fulfilled and not all the manufacturers are ready.
The objective of the MDR is the safety of the population, ensuring the safety and security of the devices available on the market.
In origin the transitional period was of 3 years, but due to the Covid-19, this deadline was postponed of 1 year. In addition to pandemic, there are many elements (Eudamed, number of notified body), which are fundamental to the implementation of Regulation that are not satisfied.
Despite several critical issues, the implementation of the regulation will allow greater control over safety and efficacy of medical devices.
INTRODUCTION
Since 26 May 2021 the Medical Device Regulation 2017/745 (MDR) is finally fully applicable (1).
All types of MD, also active implantable devices, are covered by the MDR. Only in vitro MDs (IVD) currently regulated by the Directive 98/79/EC do not fall under its scope since by 2022 they will be regulated by the European Regulation 746/2017 (IVDR).
The MDR also covers some devices without an intended medical purpose, given their similarity to MDs in functioning and risk-profile; for example, coloured contact lenses and equipment used for liposuction.
The MDR was published on May 25, 2017 in the Official Journal of the European Union.
Due to the reduced number of Notified Bodies (NBs), designated for the conformity assessment of MDs according to the MDR, and the reclassification of many class I MDs in higher risk class, with the consequent involvement of a NB on 27th December 2019, a 2nd Corrigendum to the MDR has been approved and published (1).
This Corrigendum introduces a grace period for class I de ...
