…It is apparent that Council found it important to make progress on discussions to achieve a balanced regulation for medical devices and in vitro diagnostics. But at the same time a significant number of Member States voiced concern over the unnecessary complexity of the scrutiny mechanism, the approach on reprocessing of single-use devices, the performance evaluation of in vitro diagnostic medical devices and the overall unnecessary additional administrative burden that would still need to be addressed. Industry shares these concerns.
Regarding medical devices, MedTech Europe believes that at least two issues merit particular attention and must be addressed if the EU is serious about providing equal levels of patient safety and treatment across Europe:
- The ‘scrutiny’ mechanism: The newly added “scrutiny” mechanism to bring products to the European market creates heavy procedures that will lead to unnecessary delay in the availability of devices to patients, as well as legal uncertainty in the innovation process. The proposed Regulation has other robust safety controls that strengthen the patient safety net, i.e. by enhancing the quality and expertise of notified bodies. These added controls render the additional ‘scrutiny’ procedure redundant in terms of patient safety and only serve to adversely impact the innovation and growth of the medical device industry. Moreover, the proposed ‘scrutiny’ procedure comes too late in the process and is based on a random selection of products.
- Reprocessing of Single Use devices: Patient safety is a crucial concern when it comes to reusing single use devices. The Regulation should therefore strive to ensure equal levels of safety for all products, regardless of who, in fact, is the reprocessing entity (original manufacturer, commercial reprocessor or hospital reprocessor). Council’s proposal, however, introduces three levels of patient safety depending on the entity who reprocesses. In addition, a non-harmonised approach allowing Member States to decide on national rules means that patients across the EU will not be equally treated. None of this is conducive to improved overall patient safety.
Other key areas that need additional attention include provisions on clinical evidence, hazardous substances and unnecessary bureaucratic burden.
Concerning in vitro diagnostics (IVD), the five-year transition period is in line with the initial proposal from the European Commission and is viewed positively while being in line with experience by other jurisdictions making similar changes to IVD legislation.
- Clinical Evidence: This has always been the aspect of the new IVD regulation that will be having the most impact for the IVD industry. Member States are considering extensive changes to the section of the proposed Regulation on clinical evidence. Overall, the proposal of the council greatly increases the burden of the new clinical evidence requirement for IVDs with unclear benefits for patients, while at the same time breaking the alignment with the international consensus which would have mitigated the impact of the clinical evidence requirements.
- On Companion Diagnostics: the proposed definition is too broad to be functional – too many assays fall under the new definition, creating an almost insurmountable barrier for some of the simpler assays such as cholesterol tests which will fall under the new definition.