Federal Health Minister Jens Spahn (CDU) fears supply problems for important medical devices in the event of a disorderly Brexit. Among other things, it is about laboratory tests, so-called in-vitro diagnostics. For example, they are used to test blood donations for diseases such as HIV. "I fear that the supply of patients with blood products may be at risk in Germany by mid-April 2019 at the latest," he warned in a letter to the EU Commission, reports the "Handelsblatt".
Unlike medications, medical devices, which include cardiac pacemakers and prosthetics, are not subject to regulatory approval. The task is instead in the hands of so-called "Notified bodies". Manufacturers may choose the registration office Europe-wide. Many have approved their medical devices in the UK. If the country left the EU without an agreement, certificates issued by UK testing institutes would be invalidated in the EU.
Spahn demands a transitional period
"In the case of an unregulated Brexit, without any agreement on practicable procedures, it can be assumed that tens of thousands of medical devices lose their formal marketability in the remaining 27 member states of the EU and thus are no longer available on the European market," quoted the "Handelsblatt" from Spahn's letter , Among other things, he suggests creating a transitional period of twelve months during which affected manufacturers should continue to sell their products subject to conditions.