Our services are usually tailored for each client, but here are some of the key services:
- Observes manufacturer’s compliance with conformity assessment procedure set out in the European directives which apply to the product
- Ensure law is met by having class I medical devices registered with competent authorities before being placed on the market
- Ensure their contact information is available to the manufactures to be placed on all the products they are representing, thus acting as a primary contact for the EU authorities
- Notify EU authorities of all major incidents pertaining to products
- Understand all EU regulations from each EU member state as well as four European Free Trade Association (EFTA) states, and provide notification of changes and amendments to directives that affect individual products
- Keep product’s technical file available at any time for EU member state authorities and maintain confidentiality with manufacturer’s sensitive product information, releasing them only to appropriate authorities when called upon
Many manufacturers will sometimes avoid filing vigilance reports with competent authorities as they could be seen as an implied admission of guilt. In our experience the opposite is true; filing a vigilance report will not result in regulators automatically concluding the medical device in question caused or contributed to an incident. A good authorised representative will ensure any such issues are effectively managed within the strict timetables and process required under European vigilance guidance.