Medical Devices Regulation

The current worldwide coronavirus pandemic has made the EU Commission to change the dates of the new MDR. Although this step is generally welcomed, it remains to be seen how the planned extended transition period until May 26th 2021 with regard to the approval of medical products will expire. According to BVMed, it has not been thought through how Notified Bodies will handle new and re-certifications, especially since the safety measures introduced due to the pandemic rule exculde on-site audits. In its official statement, BVMed also points out that the market surveillance of medical devices that are absolutely necessary for the care of corona patients is not uniformly regulated: Products that are part of personal protective equipment should no longer undergo the complex conformity assessment procedure - products that are required for respiratory therapy, however, should.¹

These open questions and contradictions appear to be incidential, considering that the new MDR has been openly criticised for some time. Already in May 2019 the SPECTARIS trade association for medical technology pointed out the need for action and asked for political support.² A total of seven points were listed where improvements in the regulations were recommended. The protection of existing and niche products, the maintenance of production supply chains or the starting position for clinical evaluations are not optimally regulated, they are more likely to lead to supply bottlenecks and existence problems of small and medium-sized companies. Stricter regulations should not jeopardise medical progress, it was said. In a survey carried out by the German Chamber of Industry and Commerce, almost 80% of German medical technology companies expected considerable difficulties in launching innovative products in the future. According to a recent survey by Climedo Health GmbH, 77% of those surveyed considered the new MDR to be very difficult.³ The greatest challenges cited are the lack of clarity regarding the new requirements as well as higher resource expenditures and rising costs.

The medical technology companies feel confirmed in their uncertainty by the sluggish implementation of the MDR by the EU Commission. The general doubts about the functionality of the EUDAMED database already led to the time limits being adjusted accordingly in December 2019. However, the biggest problem seems to lie with the Notified Bodies. At the time, 75% of German medical technology companies complained about excessively long waiting times from the time of application to the certification of their products. In 2019, one year before the MDR was actually scheduled to come into force in May 2020, only one Notified Body had been notified by the EU; about 40 days before the old deadline, there were only 12.⁴ How are these 12 Notified Bodies, which have been in existence up to now, supposed to be able to support the approximately 27,000 European medical technology companies and to implement all the necessary new and re-certifications, which according to the new MDR also mean increased testing efforts?

If the focus during the current Covid-19 pandemic is on preventing the supply shortages of medical devices and on the well-being of patients, this attitude and effort should or must be transferred to MDR and medical devices in general. Political decisions are necessary that not only make the transition period practicable, but also initiate an optimized MDR that guarantees both the safety of patients and the interests of medical device companies.
At this point we would like to remind of the patients of the PIP breast implant scandal in 2010, which triggered a change in the MDR. The first lawsuits against the manufacturer had already been filed in 1996. Today, almost 25 years later, there is still no adequate MDR. 

Sources in German:

1. Bundesverband Medizintechnologie e.V. „BVMed-Kurzstellungnahme zum Referentenentwurf des BMG zu einer Verordnung zur Sicherstellung der Versorgung der Bevölkerung mit Pro-dukten des medizinischen Bedarfs bei der durch das Coronavirus SARSCoV-2 verursachten Epidemie (Medizinischer Bedarf Versorgungssicherstellungsverordnung – MedBVSV)" vom 09.04.2020; https://www.bvmed.de/de/bvmed/positionspapiere-stellungnahmen

2. SPECTARIS „Fahrplan zur neuen europäischen Medizinprodukteverordnung gefährdet Patien-tenversorgung und bremst Innovationen"; Mai 2019; Ansprechpartnerin Corinna Mutter; https://www.spectaris.de/fileadmin/Content/Verband/Themenspecial/20190502_Potsdam-Papier_final.pdf

3. Climedo Health Umfrage vom 26. Februar bis 25. März 2020, über 100 Medizinprodukteher-steller; https://www.devicemed.de/proposal-fuer-verschiebung-des-mdr-geltungsbeginss-a-920655/?cmp=nl-225&uuid=867AE22A-E5AE-4487-8AA5-1AF41F258B85

4. SPECTARIS „EU-Medizinprodukteverordnung: die Uhr tickt"; download 15.04.2020 https://www.spectaris.de/verband/themen/mdr/