Tuttlingen – Exactly ten years ago, on November 28th, 2012, MedicalMountains invited to the first information event to reflect on the “innovations in medical device law at German and EU level”, better known today as EU-MDR. A look back that also reveals a great deal of vision.

"More effort in documentation." "Costs will rise." "Then a product will not come onto the market." "We hesitate when it comes to innovations." What reads like assessments from a current industry survey were actually spontaneous answers from participants who were confronted with the drafts of the new "Medical Devices Ordinance" at the information event. The worry lines could not be smoothed over by the reason given by the EU Commission a few months earlier: "The [existing] guidelines must (...) be fundamentally revised in order to create a solid, transparent, predictable and sustainable legal framework for medical devices create something that ensures a high level of safety and health while encouraging innovation.” Wording that also sounds strangely familiar to today's ears.

What followed the first meeting? As early as January 2013, invitations were sent to the second information event. In line with the legislative activities in Brussels, further working meetings and talks with political decision-makers were organized both in Tuttlingen and in Brussels. In April, a position paper was prepared jointly with the medical technology industry and signed by 400 companies. Among others, it was given to the then EU Commissioner for Health and Consumer Protection, Dr. Handed over to Tonio Borg during a visit to Tuttlingen. In October, a special meeting with members of the European Parliament took place in the Brussels representation of the state of Baden-Württemberg.

To shorten the further review: The proposal COM(2012)542 led to the regulation (EU) 2017/745, the initial forecasts have manifested themselves in tangible problems. MedicalMountains GmbH has arranged further events, held talks with companies, proposed solutions in Stuttgart, Berlin and Brussels, spoken on podiums, held its own symposia and political dialogue rounds, adapted the further training program, created ExpertTables and started a number of other activities. Even if the discussions have been going on for a decade, a change of perspective has finally taken place in public and political perception: At the beginning, the MDR was repeatedly marginalized as a purely industrial problem. In the meantime it has become clear that it will result in a supply problem. It's not up to the companies. The system still has weaknesses. In May 2024, the last certificates issued under MDD will expire. At the moment it doesn't look like everyone can be transferred to the MDR in time. This prognosis has been known for a long time.

It will therefore be interesting to see what findings will be made in ten years' time when we look back on 2022.

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