Euro Roundup: MDCG responds to new questions on MDR, IVDR rules for importers and distributors

The Medical Device Coordination Group (MDCG) has updated a question-and-answer document on how the new device and diagnostic regulations apply to importers and distributors, its first update in two years.

In the document, MDCG explains that fulfillment service providers (FSPs) are not defined as economic operators under the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). However, while that definition frees FSPs from the need to meet the obligations of economic operators, providers that carry out activities that meet the definitions of importer or distributor in MDR and IVDR need to comply with the regulations associated with such work.

Other new responses clarify that the same person can be the authorized representative and importer of a medical device – but the same entity cannot be the importer and distributor – and that the producer of a system or procedure pack is considered the importer of the individual devices contained in their packs if they put them on the EU market. Another new response confirms that leasing companies can be considered importers or distributors in some cases.

“Where leasing companies are not a part of the supply chain at all (i.e., do not carry out any of the activities with respect to the first placing on the market or making available of a device), they should not be considered to act as an importer or distributor. This would include the case where they offer purely credit/finance services in support of the activities of manufacturers or other economic operators,” the coordination group wrote.

MDCG also expanded its responses to some existing questions. The new information includes details of how importers should provide accompanying documentation with their details. MDCG is now advising importers to “consider providing the accompanying documentation with the smallest saleable package of the device” to ensure the information reaches the end user.

“In cases where there is a risk of jeopardizing the device’s compliance with the general safety and performance requirements, the importer may carry out this activity in cooperation with the manufacturer. For a device delivered in multiple boxes due to its size or its configuration, the accompanying document may be provided once rather than on each individual box provided it is supplied to a single user or location,” MDCG wrote.

The coordination group’s other expanded answers cover checks of importer and distributor verification obligations and how organizations can meet their traceability requirements by maintaining “adequately detailed records.”

MDCG Q&A

EMA updates guideline on the acceptability of names for human medicinal products

The European Medicines Agency (EMA) has revised its guideline on the acceptability of names for human medicinal products with new information on the maintenance of names and the process for resolving conflicts.

EMA, which published the sixth version of the guideline in 2014, created the document to explain the process for reviewing the acceptability of invented names for centrally authorized drugs. Two years ago, the agency began collecting feedback on planned changes to the document, resulting in comments from groups including EFPIA and Novartis and now to the publication of the seventh version of the guideline.

Through the changes, EMA aims to clarify concerns such as misleading therapeutic and pharmaceutical connotations, introduce definitions of terms including cognitive error and the umbrella branding, and formalize current practices for bilateral negotiations.

As EMA explains in a new section on bilateral negotiations, one applicant can ask to enter talks with another applicant who has a conflicting name to resolve the situation. Both parties must give consent for the Name Review Group (NRG) to disclose their identities. Until that happens, EMA considers the information to be confidential and will not disclose the details needed to enable bilateral negotiations.

NRG also provided more information on how it checks for similarities with international nonproprietary names (INNs). The group checks for “shared letter-strings” and “their sequence and location within the name” to find cases “where 50% or more of the proposed invented name is made up of INN parts.”

Another new section covers the maintenance of invented names, including their withdrawal, expiration and reuse. Applicants can ask to re-use names, but EMA warns it “may lead to the potential risk of confusion with different medicines depending on the specific case.” NRG will consider factors including product awareness and “the potential risk for mix-up” when deciding whether to allow the re-use of a name.

EMA Guideline

MedTech Europe shares advice on how to stop IVDR Class D deadline disrupting supply

MedTech Europe has published recommendations on how the EU can stop the May 2025 deadline for
Class D in vitro diagnostics (IVDs) from disrupting the supply of the technologies.

Class D IVDs are mainly used in the screening of blood, cells, tissues or organs and the management of life-threatening infectious diseases. Under IVDR, manufacturers must certify the devices by 26 May 2025. Companies will likely need to apply this year to meet the deadline. MedTech Europe expects the “financial and resource burden” of IVDR to “lead to some degree of discontinuation.”

To mitigate the risk of disruption, the trade group wants policymakers to create “a more predictable and efficient path to certify Class D devices” as a matter of urgency. If, as some European politicians have said, the deadline is delayed, MedTech Europe is pushing for the extra time to be used to “identify blockages and improve the efficiency and predictability of the system.”

The trade group is also calling for the reclassification of COVID-19 tests. The tests are currently in Class D but, in MedTech Europe’s view, “their pathogenic presentation is comparable to other non-class D respiratory viruses.”

Position Paper

Politicians reach Product Liability Directive agreement without addressing industry fears

The European Parliament and Council have reached an agreement on the Product Liability Directive, advancing a law that medtech and pharma trade groups have warned will “inevitably lead to excessive litigation and potentially non-legitimate claims.”

In response to the agreement, MedTech Europe, one of a group of trade groups that lobbied for reform of the proposals, said the revised terms “lack meaningful safeguards to ensure that a reversal of the burden of proof is only applied when very specific conditions are met.” As such, the trade group believes the directive will increase legal claims and insurance costs while “dampening innovation.”

MedTech Europe noted “certain improvements in the area of disclosure of evidence” but the changes fall short of what it wanted. The trade group also failed to overturn a medtech-specific line that singles out medical devices as an example of a “complex” product. MedTech Europe fears courts may “automatically presume defectiveness of and the causal link for all medical devices.”

Press Release, Medtech Statement

Other news:

MDCG has updated guidance on the “‘person responsible for regulatory compliance” in MDR and IVDR. The update adds information about the roles and responsibilities of the person, their registration in Eudamed and the handling of custom-made devices. MDCG also clarified that the person should not be dismissed or penalized “for performing their tasks dutifully.” MDCG Guidance

Euro Roundup: MDCG responds to new questions on MDR, IVDR rules for importers and distributors

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