BOSTON – The transition of the European med-tech regulatory system is not going well, but Oliver Bisazza, director of regulations at Medtech Europe, said device makers should nonetheless continue preparing product dossiers for recertification of existing CE marks because "you have to be able to show them you have been making an honest go of it" where re-certification is concerned.

LONDON – France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has published draft guidelines on the cybersecurity of medical devices, becoming the first national regulator in Europe to specify what manufacturers should do to protect devices against malicious attacks.