A new report from KPMG and RAPS sheds light on how prepared medical device companies are for the new European medical device regulation (MDR) as the 2020 compliance deadline approaches.
The report, which is based on a survey conducted in June 2018, received responses from more than 200 regulatory and quality professionals at medical device companies worldwide. It was released during RAPS' 2018 Convergence in Vancouver, Canada.
One of the key findings relates to a lack of understanding. Only 21% of respondents indicated their organization "has a deep understanding" of the MDR and a strategy to address the changes that the regulation will bring.
Most respondents reported that their organization falls somewhere in the middle, with 37% reporting that their companies understand the regulation at a moderate level, and 33% at only a basic level. Only 8% of respondents said their organizations have not fully read the MDR.
Despite the lack of preparation, roughly two-thirds (63%) of small- and mid-sized companies reported they are confident or extremely confident they will meet the upcoming deadlines, with respondents in North America and Europe slightly more confident than those in other parts of the world.
Due to changes in clinical data requirements under the MDR, many companies will need to fill in gaps in the clinical data for certain devices or change the processes they use to collect that data. According to the survey, 58% of respondents do not have a strategy in place to fill those gaps.
The report also points out that the MDR is not rolling out in a vacuum, as many device makers will be simultaneously working on ISO 13485:2016 certification ahead of the new standard's 2019 deadline.
According to the survey, small- and mid-sized companies are farthest behind on ISO 13845:2016 certification. While nearly half of all companies surveyed reported that they had not received ISO 13485:2016 certification, 43% and 42% of those were small- and mid-sized companies, respectively.
"The reality is, there are enough overlapping requirements between the two—e.g., business procedure and process modifications, as well as language and reference adjustments—that pursuing them simultaneously will likely be more efficient in the long-term," the report says.
Similarly, the survey also found that many companies, primarily small- (52%) and mid-sized companies (30%), have not yet initiated their Medical Device Single Audit Program audits.
The survey also polled respondents on what they perceive to be the biggest barriers to EU MDR compliance. More than half of respondents cited their own understanding of the new requirements and the bandwidth of notified bodies (NBs) as their top concerns.
Concern over the availability of NBs was also highlighted in a recent survey
conducted by Team NB which found that many NBs will not complete the necessary audits to perform conformity assessments under the MDR in time.
Click on this link for more news coverage on RAPS' 2018 Convergence from Regulatory Focus.