A survey initiated by the Regulatory Affairs Professionals Society (RAPS) and the US tax, audit and advisory firm KPMG has established that only 27% of the 230 medical device makers who responded would be fully compliant with the new EU Medical Device Regulations (MDR), coming into effect on May 26th 2020.
The new regulations entered into force on 25th May 2017, however most requirements do not apply until May 2020 for medical devices and May 2022 for in-vitro diagnostic medical devices. The purpose of the new MDR is to set more rigid rules and data collection programmes to ensure patient safety.
The survey also revealed the main concerns of the respondents. One of the main concerns was the shortage of notified bodies designated as medical device inspection authorities under the MDR. Notified bodies conduct conformity assessments of medical devices before they enter a market. As of September 2019, only five notified bodies have been designated, making it a significant barrier to MDR compliance. 58% of respondents indicated they have yet to implement changes to their Quality Management Systems (QMS) and 48% have not developed strategies for EUDAMED, the EU database for collecting and exchanging medical device information between the authorities and the European Commission (EC). Furthermore, 66% still need to develop a strategy to sustain their compliance to the MDR regulations.
The survey has deducted that “size matters” when it comes to overall preparedness for MDR. Only 24% of respondents with less than $100million revenue said they are on target to meet the deadline, as opposed to 34% of the larger organisations. Around half of respondents said they are likely to discontinue or withdraw their devices from the market due to the strains of the new regulation, and half have said they will leverage the MDR’s transitional provisions so they can continue to sell their current devices until 2024 whilst working on their compliance strategies.
These results suggest the main barriers to full compliance could be inadequate planning and budgeting, insufficient training and resourcing or a lack of communication and understanding of the new MDR regulations.
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