It seems that the medtech system is on course for calamity because NB designation under the new EU Regulations 2017/745 and 2017/ 746 on medical devices and in vitro diagnostic medical devices (MDR and IVDR) is so slow that a tailback in NB reviews is certain.
Consequently, some member state competent authorities are contemplating doing their own conformity assessments especially concentrating on the IVDR, since there have been only few applications for designation as NBs, compared to the 22 NBs that presently are working in this area under the the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).
It is anticipated that there will be a huge demand in the number of IVD companies calling for NB input, because under the IVDR roughly 80-85% of products will need the participation of a NB compared to about 10-15% currently. And to make matters worse, some of these aforementioned applicants may have to terminate activities because of Brexit.
So far, any appeals from industry to the European Commission for a delay have been ignored and it has been told to get going with its groundwork and there will be no more allowances.
Manufacturers have to do everything in their power to comply with the MDR and IVDR now, so they are not held responsible for any delay when the new EU medtech regulatory system comes fully into operation on 26 May 2020 for medical devices and 26 May 2022 for IVDs. If, when the MDR or IVDR is fully in operation, companies do not get a certificate for their products through no fault of their own, it is possible that new measures will be found to keep these products on the market.
Source: Medtech Insight (an Informa product)