Security of supply and politics - a conflict?
Third national Swiss Medtech MDR&IVDR Conference
- Bild-Infos
- Download
Berne (ots)
This year's national Swiss Medtech MDR/IVDR Conference with over 500 delegates fully focuses on the latest political developments: the transition to the new EU Medical Device Regulation (MDR) has all the looks of becoming a bottleneck in the provision of medical devices. With the imminent Brexit and the possible loss of barrier-free trade between Switzerland and the European Union (EU), the situation is likely to escalate.
The Swiss medtech industry is working all-out to meet the requirements of the MDR on time. However, a supply bottleneck is becoming increasingly apparent. The Notified Bodies (NB) are proving to be a bottleneck. Only one of today's more than 50 Notified Bodies has undergone the strict evaluation process and may issue certificates in accordance with the MDR. Barbara Züst, Managing Director of the Swiss Foundation SPO for Patient Protection is of the firm belief «The national supply of medical devices to the Swiss population must not be weakened - not even temporarily». Beat Vonlanthen, President of Swiss Medtech, calls for feasible emergency measures to be determined immediately and for industry to be involved.
The situation could escalate with the upcoming Brexit. «Some forty per cent of the medical devices in the EU are now certified by a UK NB. After the Brexit, not all of these certificates will be valid unless the competent national authorities take corrective action. If not, the supply problem will worsen», states a concerned Beat Egli, Vice President Swiss Medtech of Zimmer Biomet. Beat Vonlanthen adds «Patient care is an overriding interest. Politics must not be carried out on the backs of the ill».
In the current political environment, it is not certain that the Mutual Recognition Agreement (MRA) between Switzerland and the EU will be updated. However, this is a prerequisite for maintaining today's barrier-free movement of goods. «Legal uncertainty is detrimental to businesses. In our business considerations we are now forced to consider that we must temporarily or permanently meet the requirements of a third country to market medical devices according to the MDR in Europe», explains Roman Iselin of Johnson & Johnson. In the context of legal uncertainty, Beat Vonlanthen suggests that, to ensure national health care, Switzerland should openly discuss whether it can afford to rely exclusively on trading with CE-labelled products in the long term.
The determination of the industry to implement the MDR on time for the provision of medical products is certainly not lacking. At today's major event, over 500 delegates took part in thematic workshops on model solutions in connection with the demanding EU regulations.
Contact:
Anita Holler
Head of Communication and Public Affairs
+41 76 527 35 54 anita.holler@swiss-medtech.ch