MDR Article 32
Article 32Summary of safety and clinical performance1. For implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance.The summary of safety and clinical...
MDR Article 15
Article 15Person responsible for regulatory compliance1. Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite...
MDR Article 22
Article 22Systems and procedure packs1. Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other...
MDR Article 120
Article 120Transitional provisions1. From 26 May 2020, any publication of a notification in respect of a notified body in accordance withDirectives 90/385/EEC and 93/42/EEC shall become void.2. Certificates issued by notified bodies in accordance with Directives...
Medical Device HQ
In-house training, public and online courses on managing and developing safe medical devices