The changes last year in the Medical Device Regulation (MDR) and the forthcoming changes in the Invitro Device Regulation (IVDR) have brought about a significant change in the responsibilities of EU authorised representatives. In various EU directives, including the predecessors to the aforementioned regulations in the medical device sector, the low-voltage directive or machinery directive, an authorised representative was generally defined as a natural or legal person established within the union who has received a written mandate from a manufacturer to act on their behalf in relation to specific tasks.
The MDR and forthcoming IVDR significantly increase the responsibility shouldered by authorised representatives, the IVDR definition (34) seriously raises the bar for those taking on this role as defined below:
‘Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this regulation is without prejudice to the provisions of directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer.’
Thankfully this does not represent a shift of responsibility, more a sharing of the accountability.
The IVDR adds the keyword to the definition (25) – natural or legal person established within the union who has received and accepted a written mandate.
Acting as an EU Representative
Ultimately acceptance is essential in the activity, as an organisation or individual who is not part of the design or quality teams, you have no influence over what the manufacturer implements unless you have some sort of veto. Article 11 in the IVDR gives additional credence to this argument with point (h) The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers…(h) terminate the mandate if the manufacturer acts contrary to its obligations under this regulation.
Effectively the authorised representative is being drawn into the design and development team, reviewing the technical documentation and outcomes of post market surveillance. Hence an additional pair of eyes to review the product implemented by the manufacturer is no bad thing. This data exchange is also an important and positive step in the medical device sector. With increased emphasis on post market surveillance, ensuring as an authorised representative you are kept abreast of any non-conformances or taking this a step further, any negative trends in the product performance, that may lead to a non-conformance, is no easy activity.
As an authorised representative it does make you stop and think about the safety and efficacy of the product being placed on the market, but again no bad thing in this specific role.
The focus on independence between design teams and validation personnel has been an important topic in standards such as IEC 60601 and IEC 82304 for some years, but a regulation such as the IVDR places an emphasis on the experience and qualification of personnel. Again, this a topic well understood in other industries and standards (safety culture in the automotive industry). However, with the distribution of responsibilities toward authorised representatives it is refreshing to see the desire that authorised representatives are required to match the skills of the manufacturer’s team.
The Manufacturer’s Responsibilities
Manufacturer’s responsibilities defined in the IVDR article 10, clearly require the manufacturer (amongst other activities) to:
- Adequately risk manage projects
- Implement post market surveillance
- Draw up and maintain technical documentation
- Address changes in harmonized standards and common specifications in a timely manner
Importers and distributors are also, as with authorised representatives shouldered with more responsibility in the medical device sector.
A Hybrid Model
With the changes in the medical device sector having been applied or soon to be applied in the case of the IVDR, we now have a bit of a hybrid model. For companies who provide the authorised representative service across industries, there are now large difference from the low-voltage directive, machinery directive or general product safety directive (GPSD) to those in the medical device sector.
Although this can be accredited in part to the difference between directives and regulations, the GPSD as a directive takes an arguably better approach, using the term producer to mean the manufacturer, the manufacturer’s representative or other professionals in the supply chain.
In summary the medical device sector has taken a lead in distributing responsibility across the parties involved in placing products on the market, which helps drive quality up, but it does give more food for thought if you take on the responsibility of an authorised representative. It also makes the written mandate between parties a far more important contractual document.
By Alastair Walker, Consultant & Owner
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