In our discussions with industry stakeholders over the past few months, it came to our attention that many device companies may have neglected to consider the cost of compliance related to the EU Medical Device Regulation (MDR). With the help of our industry insiders, we developed a survey to assess company readiness in understanding those costs. Below are the survey results.
To provide context, we asked participants to provide their company size. Half of the companies that participated had global revenues below $10 million.A fairly significant portion of respondents (40%) said their company did not have an active program that meets the requirements of EU MDR.32% of respondents expect compliance with EU MDR will take up more than 8% of their company’s EU revenue.An estimate of the cost of compliance connected to global revenue was much smaller.
Continue to the rest of the survey results on page 2.
Of the respondents who expect their companies to actively reduce the number of products available with the CE Mark as a result of EU MDR, half said the reduction would be 10–20%.Respondents were most concerned with clinical evidence requirements and the availability of notified bodies.
In an alarming response, 78% of survey participants expect to change notified bodies due to EU MDR, and 76% don’t have faith that notified bodies will be able to complete file reviews to meet the deadline.
The position paper from the European Commission’s Medical Device Coordination Group (MDCG) recommends an extended timeline to allow certain MDD or AIMDD certified legacy devices to come into compliance with MDR.
On Monday, March 20, the EU MDR extension approved on March 7 came into effect following its official publication in the Journal of the European Union.
The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device…
Maria Fontanazza has more than 15 years of experience in journalism, marketing and communications. She was previously marketing communications manager and market research manager at Secant Medical, Inc., a manufacturer of biomedical textiles and advanced biomaterials. Fontanazza also served as an editor at MD+DI and has authored articles that have appeared in domestic and international industry publications. Fontanazza has a B.A. in Journalism and Mass Communications with a concentration in New Media and Visual Design, and a Minor in Fine Arts, from St. Michael’s College in Colchester, VT. Follow her industry insights on Twitter at @MariaFontanazza. Contact Maria
