The Role of Medical Device Economic Operators in Europe
Authorized representative. Importer. Distributor. Person Responsible for Regulatory Compliance. The new European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certainly keep regulatory professionals on their toes. The duties associated with these four roles are outlined in Articles 11, 13, 14, and 15 of both regulations, respectively. However, they can be somewhat confusing because there is significant overlap in what some of these so-called “economic operators” do. In this article, we will give you a rundown on what each of these partners is supposed to do for you, the manufacturer. Don’t miss the table further down in this post.
Companies established outside of the European Union (a place of business physically outside the Union) generally need to appoint a European authorized representative, also known as an AR. The AR’s role is to confirm basic compliance with the EU MDR prior to placement of devices on the market, and also serve as a local point of contact for competent authorities should there be a problem with your product in a European market. The requirement to appoint an authorized representative has been around for decades, and this role is much the same as it was under the previous regulation.
Many manufacturers are just now learning about the importer requirements specified in Article 13 of the EU MDR. Some assume this is a new requirement, but in fact the role of the importer has been well documented in the Blue Guide for a long time. This entity and other economic operators have been included in the EU MDR, which is consistent with other Directives and Regulations published in recent years. The EU MDR highlighted and elevated the role of the importer as a sort of gatekeeper required to examine your compliance with specific aspects of the regulation. Importers are also responsible for placing your product on the European market and, as such, they can be held financially liable for your noncompliance. Review the definition of “placing on the market” and its description in the Blue Guide, as it is important to understand responsibilities of each operator. There’s a good article here about what happens if you don’t select an importer.
Of course we don’t have to explain to you what distributors do, but it is important to know that their compliance responsibilities have been clearly spelled out in Article 14 of the EU MDR. Your distributor – in cooperation with your importer and authorized representatives – now plays an important part in ensuring your compliance with the MDR. Similar to the importer role, there are responsibilities when placing product into service (or, in basic terms, providing to end users or customers). Again, it’s important to review the definition of “placing product into service,” as this can be a differentiating point between an importer, distributor, or someone who takes on both roles simultaneously.
Person Responsible for Regulatory Compliance (PRRC)
Although not considered an economic operator in the EU MDR, this is a new requirement in the regulation. Many manufacturers would simply appoint an appropriately qualified person internally to fill this role, but small companies lacking this expertise in-house are allowed to outsource this to an external company. The key is that the PRRC must be “permanently and continuously” available, as specified in Article 15(2). We point out this role because it is needed for both the manufacturer and the authorized representative, but not required for an importer or distributor.
As you can see in the table below, there is significant overlap between the responsibilities of the distributor, importer, and authorized representative. This may seem like the work of technocrats run amok but, in setting up this system, European regulators wanted to underscore the necessity of following the EU Medical Device Regulation. As these roles are defined in the Blue Guide, this is consistent with many other products that are marketed and sold in the European Union.
Regulatory Responsibilities Under the EU Regulations
EU Authorized Representative (Article 11)
EU Importer (Article 13)
EU Distributor (Article 14)
PRRC* (Article 15)
|Verify appropriate conformity assessment procedure has been carried out||X|
|Verify presence of Declaration of Conformity||X||X||X|
|Keep Declaration of Conformity available||X||X||X|
|Verify presence of CE certificate**||X||X|
|Keep CE certificate(s) available**||X||X||X|
|Verify presence of technical documentation||X|
|Keep technical documentation available||X||X|
|Confirm labeling meets requirements||X||X|
|Confirm instructions for use (IFU) are present||X||X|
|Confirm product registration in EUDAMED***||X||X||X|
|Verify that UDI has been assigned||X||X|
|Verify entity name added to labeling or accompanying documentation||X||X|
|Verify proper storage and transport conditions||X||X|
|Coordinate and communicate complaints, and field safety corrective action, as appropriate||X||X||X|
|Verify that postmarket surveillance obligations have been met||X|
|Verify that serious incidents and FSCA get reported||X||X|
|Analyze serious incidents, FSCA, vigilance data||X|
|Compile incident trend reports||X|
|Cooperate fully with competent authority||X||X||X||X|
|Responsibility for “placing” products on EU market||X||X|
|Financially liable for noncompliance||X|
|Legally liable for defective devices||X|
*While specifics are not explicitly stated in Article 16, it is understood that the PRRC will check many aspects of compliance with the EU regulations prior to release, as indicated in Article 16(3).
***Once fully operational.
Additional Requirements for the UK and Switzerland
As if the table above wasn’t enough to make your head hurt, there are new representation requirements for medical device manufacturers exporting to the United Kingdom or Switzerland.
- United Kingdom As you may have heard, a little thing called Brexit happened some time ago. After the UK left the European Union, they reinstated their own regulatory scheme called the Medicines and Medical Devices Act (MMDA) with additional provisions. As such, they now require manufacturers without a UK entity to appoint a UK Responsible Person (similar to an EU authorized representative) and a UK importer.
- Switzerland Switzerland has never been a member of the European Union but they closely followed EU laws using mutual recognition agreements (MRA). That was true with the Medical Devices Directive. Unfortunately, negotiations to renew the MRA between Switzerland and the EU broke down in 2021, and as a result the Swiss have also reinstated their own medical device regulations with additional provisions, much like the UK. The bad news is that if you are currently importing devices to Switzerland, you now need to appoint a Swiss authorized representative and importer. These new requirements certainly shine a light on the benefits of having a “Union.”
In the end, it is ultimately the manufacturer’s responsibility to ensure full compliance with the EU, UK, and Swiss regulations, with the importer, authorized representative, Responsible Person, and distributor all double-checking that effort.
Want to Learn More About the EU MDR?
Oriel STAT A MATRIX has been helping medical device manufacturers learn about the MDR since it was first released in 2017. We offer a training classes on how to implement the MDR or audit to it. Our EU MDR consulting team is also available to assist with a variety of issues.