Daily Buzz

The European Commission has been publishing MEDDEV guidance documents like there's no tomorrow since the start of the year. At the end of last month, it released guidance on stand-alone software used in healthcare applications, which medtech lawyer/blogger Erik Vollebregt profiled on medtechinsider. (Keep your eyes peeled for a more thorough reading of the document by Vollebregt on emdt.co.uk in the coming days.) MEDDEV 2.1/6 may have overshadowed another document that the Commission put out recently involving authorised representatives. And that could be worrisome, notes Vollebregt on his medicaldeviceslegal blog, because it basically rewrites the playbook. "Everything you know is wrong," says Vollebregt. Do we have your attention?

An authorised representative is defined as any natural or legal person established in the European community who is explicitly designated by the manufacturer to act on his behalf and may interact with authorities and bodies with regard to the manufacturer's obligations under the Medical Devices Directive, says Vollebregt. You need an authorised representative if you place a device on the market under your name but do not have a registered place of business in a member state. Authorised representation can be an internal or external function, depending on how a company is organised. EU law requires an authorised representative so that authorities have an interlocutor for the purposes of postmarket surveillance. "There is more," writes Vollebregt, "which is described in detail in the MEDDEV and it’s not new." What is new, he adds, are the requirements of the agreements that bind authorised representatives with the manufacturers and the supervision of these agreements, which is delegated to Notified Bodies.

It has been Vollebregt's experience that almost "none of the agreements out there comply with the requirements." His advice to manufacturers that have authorised representation is to carefully review the agreements in place. If you fit that profile, you can start by checking out his blog post, which describes in some detail the requirements and the supervisory role of Notified Bodies.