Federal Minister of health, Jens Spahn (CDU) fears in the case of a disordered Brexits supply problems for important medical products. Among other things, it comes to lab tests, so-called In-Vitro-diagnostic medical devices. For example, blood donations are tested for diseases such as HIV. “I fear that in Germany at the latest by mid-April 2019 the care of patients with blood products could be compromised,” he warned in a letter to the EU Commission, reported the “Handelsblatt”.
Unlike drug products, which include pacemakers and prostheses, no authority decides in the case of medical admission. The task is instead in the hands of so-called “Notified Bodies”. The manufacturer may choose the licensing body in Europe. Many have allowed their medical products in the UK. In the case of an EU-exit of the country without the agreement of the British institutes certificates issued in the EU, invalid.
Spahn calls for transition period
“In the case of a non-Brexit is without the understanding of practical procedures assume that tens of thousands of medical products lose their formal movement in the rest of the 27 member States of the EU and on the European market no longer available”, cited the “Handelsblatt” from Spahns letter. He suggests, therefore, among other things, to provide a transitional period of twelve months, in the concerned manufacturers their products under conditions more likely to sell.