Industry group MedTech Europe is voicing concerns over the implementation of the EU’s new Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulations, which are set to go into effect in May 2020 and May 2022.
The industry group was specifically concerned about the industry’s ability to keep products on shelves after the deadlines for implementation are passed.
MedTech Europe called on the European Commission, European Parliament and all EU member states to “provide solutions that will rapidly install the functionality of the new regulatory systems and thereby safeguard the continued availability of life-saving and life-transforming medical technology products,” according to the letter.
The group warned that their ability to stock items “could be seriously jeopardized by the slow progress in putting into place the critical infrastructure that will enable the new regulatory systems to work.”
Products that weren’t re-certified would be made unavailable after the deadline, the group warned, limiting access to patients and healthcare providers.
MedTech Europe said that implementation of the new regulatory framework was lagging, and said that after 14 months only two of 18 “system-critical implementing acts” had been published. In addition, notified bodies still need to be designated before they can assess and certify medical devices under the new regulations, the group warned.
“A fully-functioning Notified Body system is needed early on, with sufficient capacity to manage the workload under the current and future regulatory framework in a timely manner. As of today, our assessment is that Notified Body availability with needed expertise and sufficient capacity cannot be ensured early enough and hence an urgent solution is needed.
The group also voiced concerns about complications brought about by the Brexit, estimating that currently between 30% and 40% of medical tech in EU are certified with UK notified bodies. MedTech Europe said that it is uncertain whether those bodies would continue to operate in the EU, or if their capacity will need to be transferred to other EU notified bodies.
“MedTech Europe is ready to cooperate with the EU institutions and all affected stakeholders to identify and deliver an optimal way forward. We urge all concerned parties in the strongest possible terms to act now, in the interest of patients and industry alike,” MedTech Europe wrote in its letter.
