In January, the Association of German Chambers of Commerce and Industry (Deutscher Industrie- und Handelskammertag, DIHK) and SPECTARIS – German Medical Technology Trade Association (Fachverband Medizintechnik) published some interesting data (DIHK/SPECTARIS-Umfrage, 2019). In a joint research survey, 320 companies completed an online questionnaire that was subsequently published by the German Chambers of Commerce and Industry. According to the publishers, respondents voiced the following concerns:
- It will be more difficult to bring innovative products to the market in the future.
- They will be forced to cut their product portfolio.
- Increased costs
- There is an insufficient number of Notified Bodies to get all devices certified in time.
What is certain is that manufacturers can expect higher costs to certify their products, which is why they have to choose carefully and decide which devices are worth the effort. Achim Dercks of SPECTARIS cautions: "There is a danger that many smaller companies will experience market access problems for their products. This threatens their very existence and subsequently slows down the pace of innovative medical devices to help patients.” (Press release: February 1, 2019)
At this juncture, it’s still unclear whether and how the new Regulation will economically impact manufacturers. Large companies are in a position to create new jobs to handle the extra work that’s required. Small companies tend to rely on external consultants, which means additional costs, or they assign the new task to a team member, which in turns means they will lack an employee in another area. Whatever the solution may be for the respective enterprise, all companies should already have many approvals and certifications ready at this point to be fully prepared once the Notified Bodies are available. Even though the new Regulation ultimately requires more work for medical device companies, it can actually benefit patients by increasing their safety.
Please refer to the box below for more helpful links to the MDR and its implementation.