The EU Commissioner for Health & Family Welfare, Oliver Varhelyi, went on to confirm on March 20 that the regulations when it comes to medical devices – MDR as well as in vitro diagnostics – IVCR are going to be revised at the end of 2025.
The consultation happened to draw almost 500 contributions from the industry players in addition to associations and also federations. Pharmaceutical giant Takeda, who is one among them, stressed the essentiality of syncing MDR/IVDR with the digital framework of the EU as well as its pharmaceutical regulations and also clinical trial regulations.
For this, Takeda is already coming up with creating a single governance structure so as to enhance coordination between MDVR as well as IVDR, in addition to other regulations that are affecting the sector.
In the same way, Roche, the Swiss pharma giant, has called for an impact evaluation so as to assess the MDR & IVDR’s coherence with certain other EU legislation. MedTech, which represents the medical technology domain, went on to warn that the fragmented system delays the CE marking and hence hurts the competitiveness of the industry in Europe. Citing the contradictory responses, it has apparently also asked for a better sync between the European Medicines Agency – EMA, National Competent Authorities – NCAs as well as Notified Bodies.
Clarification is also required on the product lifecycle rules as well as Article 16 of the MDR, which goes on to cover reconditioning as well as relabelling of devices when combined with pharmaceuticals.
According to MedTech, neither the guidelines rolled out by the EMA nor the Medical Device Coordination Group – 2021-26 guidance specifically take into account the situation of the pharmaceutical companies that typically go on to acquire CE-labelled medical devices in bulk coming from the legal manufacturer. Meanwhile, as far as patients are concerned, the MDR must have clear reporting pathways for feedback along with a backup plan in case of shortages so as to avoid months or even years of physical endurance, opined the European Patient’s Forum.
From the hospital side, Oslo Medical University Hospital students went on to state that the MDR can as well raise the prices of medical devices sans promising better quality. As per the European University Hospital Alliance, the MDR went on to cause some critical delays in the certification part, thereby leading to shortages as well as reduced device variety, specifically in academic hospitals that treat rare diseases.
Health Care Without Harm Europe has gone on to urge some clearer definitions when it comes to single-use devices, commitments pertaining to phasing out toxic materials, as well as more incentives in order to reuse certain medical devices.
