The industrry association for medical device notified bodies, TEAM-NB, explains that while extending the deadline for transition to EU Medical Device Regulation (MDR) compliance has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time to meet the new deadlines.
In its recently issude position paper ‘New MDR Transition Timelines and Notified Body Capacity’, the association states:
“From the outset of the MDR, it was clear that the new requirements would make the certification process more extensive. Thus, the demand for notified body capacity would increase and manufacturers would need to allocate more resources to fulfil their new obligations. Consequently, notified bodies have invested extensive time and resources to expand their capacity.”
“Nevertheless, notified bodies are currently confronted with several challenges that consume valuable resources, rather than focusing on their primary regulatory tasks.”
The paper also notes that as the deadlines are now extended, manufacturers seem to be showing show less urgency in submitting their applications. The group said they currently have more capacity to accept applications but warned manufacturers not to waste that opportunity, because as the deadlines approach, there may not be as many resources available to review and recertify their products.
The group also notes that the greatly delayed implementation of EUDAMED has led to significant challenges for NBs to meet their MDR documentation requirements. Without EUDAMED, NBs have been feeding data into national databases, which ultimately will have to be transitioned into EUDAMED and lead to unnecessary administrative burdens.
Copies of the position paper are available from the TEAM-NB website.