New MEDDEV on Authorized Representatives
The EU Commission released a new guidance document for the European Authorized Represenatives (EAR) last month relating to questions of application of the EC-Directives on Medical Devices.
This new document sets important guidelines for the EARs in respect to two features:
- It summaries the roles and responsibilities of the Authorized Representative as mentioned in the medical devices Directives (MDD/93/42/EEC; AIMDD 90/385/EEC; IVDD 98/79/EC)
- It also describes the expectations of the European Union Member States regarding the role of the EAR concerning market surveillance.
After months of important consultations with different interested parties, competent authorities, industries and the like, the European Commission has released a new guideline document that reveals a major step in the regulation of the European Authorized Representatives’ (EARs) roles.
The provisions of the new guidance document relating to questions of application of EC-Directives on Medical Devices (MDD 93/42/EEC ) mainly refer to the relationship between the European Authorized Representatives (EARs) and the manufacturer and the increased importance of the EARs in terms of market surveillance.
In what concerns the role of the authorized representative (AR) a detailed description has been provided in the new guidance document, while this does not change the responsibilities of the manufacturer.
The main highlights of the roles of the AR and the relationship with the manufacturer:
- The requirement to have an AR is applicable to all medical devices placed on the Community market, where the manufacturer is based outside of the EU. This is also valid for devices intended for clinical investigation (MDD/93/42/EEC; AIMDD 90/385/EEC) or performance evaluation (IVDD 98/79/EC)
- In regard to the conformity assessment any manufacturer can delegate the performance of certain requirments of the Directive to his designated AR, but these aspects shall be clearly stipulated in the contract between the manufacturer and the AR
- The AR is obliged to keep certain information at the disposal of the national authorities, such as declarations of conformity and technical documentation
- An AR must be able to provide all documentation and information that a market surveillance authority may require for the purpose of market surveillance
- The AR must possess appropriate knowledge, expertise and resources to assess and verify the above (see Authorized Representatives services)
- In the event of a disagreement, where the AR considers that the manufacturer is not complying with the requirements of the Directives, it has a duty to communicate this to the manufacturer. If the disagreement continues, the matter should be submitted to the AR’s Competent Authority for decision
- The Notified Bodies should verify that a manufacturer who does not have a place of business in the EU, has designated an AR and that the appropriate contract demonstrating delegation of appropriate responsibilities is available
There are two instances in which the AR can and shall take the necessary steps to rescind the contract with the manufacturer:
- If the manufacturer does not provide him with the access to the necessary information
- In the event of a clear non-compliance by the manufacturer that could engage the responsibility of the AR and which the manufacturer refuses to correct. Furthermore, the AR has even the obligation to rescind the contract if the non-fulfilment of the manufacturer’s obligations causes him to infringe national law