Good preparation required for possible no-deal Brexit

A Brexit in the no-deal scenario could cause disruptions in the production processes and transport routes of medical devices and in-vitro diagnostics. In particular, the certification between the EU and the United Kingdom is causing headaches. That is why it remains important for healthcare institutions and manufacturers, but also purchasing organizations and wholesalers, to prepare themselves well.

This is stated by the Medical Technology sector, part of FHI, following the latest rounds of consultations with the Ministry of Health, Welfare and Sport (VWS). Together with other parties, the focus was on the validity of certificates. Many parties are unclear, such as the question of whether future CE certification by British inspection bodies will still be valid.

Brussels now has more clarity trying to provide information on the use of medical devices and in vitro diagnostics after a no-deal scenario. Medical devices with a CE certificate issued by a British notified body (inspection body) that are currently placed on the EU market may continue to be used and traded in the EU after 29 March 2019. However, new stocks of the same products with an identical British certificate for which a supply contract has not yet been concluded between the manufacturer and a supplier, and for which the production process has not yet been completed, may be used and traded in the EU after 29 March 2019. not be marketed more extensively on the internal European market.

According to Minister Bruins, there are still intensive discussions at the highest European level to prevent any shortages of products. This must be done with a joint approach.

Despite the fact that the information from the minister and the EU provides more clarity, FHI Medical Technology is not yet satisfied: "We are concerned about the availability of products. We will continue to work hard in Brussels for a coordinated approach to possible shortages", says Luc Knaven, director of Medical Technology.

The United Kingdom is set to leave the European Union on 29 March. However, British politics are deeply divided over whether the exit should be with or without a treaty, and if so, in what form.