Harmonized standards are key for applying Europe’s new medical device and in vitro diagnostics regulations, but the European Commission’s latest draft of the standards to be considered is filled with technical errors that would result in a lack of standardization, MedTech Europe said.
The commission’s standardization request includes a list of standards to be considered for harmonization under each regulation, and the request proposes timelines for adopting the standards. However, MedTech Europe said that if the standards were to be implemented, they would result in a deficiency of harmonized standards.
“This situation will lead to a lack of alignment between notified bodies with respect to the conformity assessment procedure and potential confusion within the system as a whole, possibly allowing non-state-of-the-art products to enter the market,” MedTech Europe says in a new position paper.
MedTech Europe said that list of standards in Annexes I and II of the standardization request lacks several key horizontal standards for both IVDs and medical devices that are “vital to ensure safety and performance.” In addition, references to these standards are already listed in the EU’s Official Journal under IEC 61326-1, ISO 14708, ISO 14630 and ISO 17664.
Annexes I and II specify timing for adoption, but the timelines “appear to be misaligned with the enforcement dates of the new regulations. For example, the EN 60601 series related to basic safety and essential principles of [medical devices] are due to be adopted by May 27, 2024, which is four years after the date of application of the MDR on May 26, 2020,” the association said.
The requested standards also hinder devicemakers from complying with applicable regulations, because manufacturers need to conform to the general safety and performance requirements that take into account the state of the art. However, “it may be possible that state-of-the-art would not be considered if manufacturers were to apply the [proposed standards],” the paper states.
Given the time-intensive process to approve a standardization request, such a closed list “hinders CE-marking of innovation devices,” the association said.
The current Annex III of the draft standardization request would effectively halt the harmonization of standards that reproduce the requirements sets out in the regulations, MedTech Europe said, stressing that this approach “would require extensive rewriting of standards to ensure no cross-over or the exclusion of standards only because of editorial issues.”
MedTech Europe is calling on member states, notified bodies and standards organizations to contact the Commission to emphasize the potential long-term impact on product availability, approval, safety and innovation with a direct consequence to patient safety and the delivery of state-of-the-art healthcare.
In related news, seven device and IVD stakeholders including MedTech Europe, released a joint statement that calls on the Commission and member states to accelerate the implementation of the regulatory system “to prevent a ‘cliff-edge’ scenario for patients, healthcare professionals and healthcare systems in Europe.
The letter notes that the implementation date for the new regs is less than a year away but the system is far from being functional. “Immediate action is needed now to avoid severe disruption of product supply to patients and hospitals as well as to safeguard the innovation capacity of the sector in developing new life-saving and life-transforming technologies,” the joint letter states.
Read the position paper here: www.fdanews.com/06-06-19-Medtech.pdf.