What are the requirements for regulatory notification of my medical device product?
Council Directive 90/385/EEC
(5 September 2007)
(h) ‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
1. Any manufacturer who, under his own name, places devices on the market in accordance with the procedure referred to in Article 9(2) shall inform the competent authorities of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.
1. Member States may request to be informed of all data allowing for the devices to be identified together with the label and the instructions for use when the devices are put into service within their territory.
2. Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union.
2. For devices referred to in the first subparagraph of paragraph 1 the authorised representative shall inform the competent authority of the Member State in which he has his registered place of business of all details as referred to in paragraph 1.
3. The Member States shall on request inform the other Member States and the Commission of the details referred to in the first subparagraph of paragraph 1 given by the manufacturer or authorised representative.