(05/2020) Between February and March 2020, the Munich start-up Climedo Health carried out a survey on the status of EU MDR implementation. A total of 110 companies took part, the majority (86%) from German-speaking countries. The central survey result (probably) not surprising: Many companies are not yet or poorly prepared. The MDR moratorium for one year announced by the EU Commission in mid-March and approved by the EU Parliament on April 17th should therefore be seen as an opportunity to rethink your own MDR strategy and tighten the reins where necessary.


Central survey results at a glance
77 percent of the survey participants consider the MDR to be "very challenging". The biggest hurdles mentioned in this context are "Lack of clarity on requirements" (72.9%) and "Increased resource / cost expenditure" (71.9%). Almost 50 percent still see the aspect of “required clinical tests” as a challenge. In terms of the costs associated with implementing the MDR, 32 percent estimate that additional costs of over 5 percent of annual sales will be added. 48 percent of those surveyed estimate these additional costs in the range of 1 to 5 percent of annual sales. 54 percent will have their MDD (Medical Device Directive) certificates extended, but only 3 percent are already MDR-compliant. 72 percent of the companies taking part in the survey stated that they are still in the process of developing a quality management system that complies with the EU MDR: 43.2 percent of them have a strategy and are currently making the relevant changes; 10.5 percent still have to develop a strategy; 17.9 percent carried out a gap analysis. According to the survey results, only 26.3 percent already have a fully MDR-compliant quality management system. 25 percent do not (yet) have a PRRC (Person Responsible for Regulatory Compliance) for compliance matters. It should be noted here that a PRRC is not required for all companies. In a good 50 percent of the survey participants, the notified body with which they work is MDR-certified. But at least 35 percent stated that they did not (yet) have an MDR-certified notified body. 47 percent of those surveyed do not (yet) have a PMS (Post Market Surveillance) plan. And only 33 percent use an EDC (Electronic Data Capture) system for clinical data collection. 48 percent still work with paper-based solutions, 69 percent use Excel tables. Multiple answers were possible here.

Use time, do homework
From Climedo’s point of view, the results show that only a few companies were prepared for the new regulation with regard to their post-market monitoring (PMS), quality management systems (QMS), notified bodies and data acquisition systems (as of mid-March 2020). Although some requirements would not have been compulsory by May 26, 2020 by taking advantage of the transition period, the vast majority of participants (77%) nevertheless rated the MDR as “very challenging”. The authors of the study recommend MedTech companies to use the planned postponement of the MDR by 12 months to May 26, 2021 (as of mid-March) as an opportunity to rethink their MDR strategy and to maintain communication with suppliers and notified bodies. It is now crucial to use this time sensibly and to address the points that could be dealt with independently of the coronavirus pandemic. The summary of the survey results can be requested online directly from Climedo free of charge. Short link: https://bit.ly/3bCsnxt

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