The Authorized Representative is a natural or legal person, explicitly designated by the manufacturer and established within the Community, who acts on behalf of the manufacturer and may be consulted by the authorities and bodies within the Community in lieu of the manufacturer.
The Medical Devices Directive requires that the European authorized representative (EC REP) appear on the label. Moreover the EC REP is obliged to maintain the technical dossier of the Medical Device in order to reply to any requests from the Competent Authorities.
Di Renzo Regulatory Affairs, a company with offices in both Italy and the UK, has many years of experience in the medical device and in vitro diagnostic field.
As is required by the forthcoming new regulation, the staff of the Medical Device Department consists of qualified people with expert knowledge and experience regarding the regulatory requirements for medical devices in the European Union.
As EC REP Di Renzo Regulatory Affairs is able to assist with the following:
- performing product registrations according to the MDD 93/42/EEC, IVDD 98/79/EC, AIMDD 90/385/EEC in EU countries
- manage incident reporting according to the relevant directives within Europe
- be the contact point for European Competent Authorities
- cooperating with the competent authorities on any corrective action that may be necessary to eliminate the risks posed by devices;
- immediately inform the manufacturer of any complaints or reports from healthcare professionals, patients and users regarding suspected incidents related to a device
All activity will be agreed on beforehand by means of a technical contract (mandate) between the manufacturer and Di Renzo Regulatory Affairs.