European Commission takes initial but crucial steps in efficiently communicating the changes brought by the Medical Device Regulation (EU) 2017/745 (MDR) and the In vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
Within this article we shall highlight most significant novelties of the new Regulations that are specified in Commission’s most recent communication campaign with the focus on manufacturers.
Generally speaking, compared to current 93/42/EEC (MD) and 98/79/EC (IVD) Directives, both Regulations put greater emphasis on fostering continuous safety evaluation throughout the life-cycle of devices, including precise clinical data with increased stringency by Notified Bodies (NB).
Manufacturers shall note the scope of Regulations has been broadened. This implies that the manufacturer needs to make sure if his device has to be reclassified and also to verify whether a scrutinization by a NB is now required.
To give some examples, the scope of Medical Device Regulation now includes “products without an intended medical purpose” which implies the need for manufacturers of devices with no medical purpose to comply in a line with the Common Specifications (CS). As for IVDR, the list-based approach for assigning the risk class as it was used under Directive is replaced with the four risk categories – A(lowest), B, C or D(Highest). As Devices in Classes B, C and D will require conformity assessment by a Notified Body, around 85% of all IVDs will require NB involvement.
Regarding other freshly introduced obligations for manufacturers, new legal frames require not only to establish an effective risk and quality management systems but also to have structure in place to cover their financial responsibility for harm caused by defective devices; to have a designated person responsible for regulatory compliance within the company; additionally, manufacturers of implantable devices will have to provide an implant card for the patients. On top of that, it is essential for each manufacturer to verify whether a Notified Body that was engaged by him in a past will be designated under new Regulations and whether the newly defined scope of NB is covering manufacturer’s devices.
Yet, one of the most crucial changes when comparing MD/IVD Directives to Regulations are the reinforced requirements for clinical evaluation. Under the Directives, in most of the cases it includes the collection of clinical data which is taken whether from the literature available or equivalence studies with similar devices for which clinical data already exists. According to the new Regulations, the idea of backing clinical data with equivalence studies is significantly limited with the tighter rules introduced. This implies that almost in all cases, implantable and Class III medical devices must now undergo clinical investigations.
To sum up, prior to the date the Regulations become fully applicable (as from May 26th 2020 for MDR and May 26th 2022 for IVDR), the manufacturers shall be certain all their products are classified accordingly, devices documentation and evidence of compliance conform with the MDR/IVDR and they have the structure in place to handle clinical evaluation, risk and quality management, post-market surveillance and liability for defective devices., etc.
For more information on MDR/IVDR related timelines and deadlines, please click here.