By Clare Huntington, Director, Head of Medical Devices / IVD UK
The EU Medical Devices Regulation (EU 2017/745) has introduced new roles and responsibilities across the four legal entities referred to as “economic operators”. Essentially, an economic operator is any entity involved in either manufacturing or placing a medical device on the market. The term “economic” implies some ownership of responsibilities, though this varies depending on the “operator” involved.
The four are: manufacturers, the authorised representative, importers and distributors. The responsibilities for each are outlined in various articles in the regulation, but with change inevitably comes some uncertainty.
Adding responsibilities for the manufacturer
The first of these, the manufacturers, face many more responsibilities. One of the most significant of these is the requirement to register on the Eudamed database and ensure the information there is reviewed and updated. This is made additionally challenging because three of the six interconnected modules have yet to be made available, with development expected to continue through 2023 and an audit in early 2024.
Another complexity for the manufacturer is the requirement to appoint a person responsible for regulatory compliance (PRRC), a role similar to the qualified person in the pharmaceutical industry, who is responsible for performing checks and signing off every stage. These different stages – clinical trials, CE marking, post-marketing activities and so on – can be managed by different people but all must meet certain qualifications with regard to degrees and years of professional experience.
Other role changes for manufactures include putting a unique device identification (UDI) in place and a requirement for all manufacturers, irrespective of the class of the device, to have a full quality management system.
New oversight needed by authorised reps
The second economic operator, the authorised representative, has a lot more responsibilities than in the past and must ensure they are familiar with the manufacturer’s products. They also need a PRRC, and that person cannot be the same as the PRRC for the manufacturer. They must also update information on Eudamed, though their responsibilities there are not as extensive as for those of the manufacturer.
However, they do need to have a mandate in place indicating which products they are representing, uploaded onto Eudamed, and which could be removed if at any point the authorised rep realises that the device is not compliant, or the manufacturer is not fulfilling their obligations.
Changes for importers and distributors
When it comes to importers, the chief responsibilities include checking the device has been CE marked, that there is an authorised representative if it’s needed, that the labelling and information for use documents (IFUs) are compliant with the MDR, that a UDI has been assigned and including their name on either the device packaging or a document accompanying the product. The importer will also have to register for Eudamed; they must ensure the product, when it is in their care, is stored and transported in compliance with the general safety and performance requirements; and they must keep – and share with relevant parties – a register of complaints.
The last of the four economic operators is the distributor, who also has some responsibilities around ensuring certain requirements are in place – CE marking, IFUs, labelling, etc. – as well as informing the manufacturer, authorised rep and importer if they believe a device is not in conformity. One bigger responsibility for the distributor relates to complaint management, since they are often the first group to hear about any issues.
One issue is the fact that the distributor very often won’t be in the medical device field, and they wouldn’t necessarily know about these requirements. As a result, manufacturers must take care when they have agreements with these companies to make sure that they are aware of their obligations under the MDR.
Listen now to our podcast to learn more about economic operators, who is impacted, what the implications are and what these changes look like in practice.