News about GMP/cGMP

26.04.2019

Switzerland: Legal uncertainty for medical device manufacturers

In terms of the InstA (Institutional Agreement) between Switzerland and the EU, there is legal uncertainty. This directly impacts the entire medical technology industry in Switzerland, as it does not ensure an update of the MRA (Mutual Recognition Agreement) Switzerland/EU. Will the third country requirements of the MDR perhaps soon apply to Switzerland? And what has to be done to be prepared?

Switzerland’s medical technology lobbying group, SwissMedtech, published recommendations to Swiss medical device manufacturers on 25 April 2019.  The standstill of the InstA "has a direct impact on the medical technology industry," says Swiss Medtech. Swiss equipment manufacturers may have to meet the requirements of a third country in order to export products to the EU in accordance with the new EU Medical Devices Directive (MDR).

The Association recommends that manufacturers’business considerations should includethat they may have tomeet the requirements of a third country in order to be permitted to export products to the EU in accordance with the new EU Medical Device Regulation (MDR). In concrete terms, this means that they would have to appoint an authorised representative with a domicile in the EU,in addition to adaptingall product labels. “Depending on the complexity and scope of the product range, meeting these two requirements can take two years,” says Beat Vonlanthen, Presidentof Swiss Medtech.

The capacities of the Notified Bodies (NBs) are also called into question, as are the effects of Brexit, which cannot yet be foreseen. However, it is up to each individual company to decide whether to switch to "third country requirements" or wait and see.


Source:

SwissMedtech: Recommendations

SwissMedtech: Press release



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