UK MHRA Medical Device & IVD Registration: Step-by-Step Guide
December 18, 2023
MDCG 2019-07 Updated: MDR/IVDR Art. 15, Person Responsible for Regulatory Compliance (PRRC)
January 3, 2024MDCG 2021-27 has been revised to add six new Q&As and update three existing Q&As. MDCG 2021-27 Rev. 1 is available: HERE
Newly Added Q&As
Below are the six new questions, and a summary of the answers. Notably absent? A Q&A addressing the importer role for direct sales to end users.
Please review the guidance for the full answers.
Are Fulfilment service providers (FSP) as defined in Article 3(11) of Regulation 2019/1020 on market surveillance (MSR), considered economic operators under MDR/IVDR?
It depends on their actions and role.
Generally, they are not defined as economic operators. However, if the FSP carries out any activities that meet the definition of an importer or distributor, then they will be considered economic operators and required to meet those obligations.
Can the same natural or legal person assume the role of authorised representative as well as importer for one individual device under the MDR/IVDR?
Yes, they can. However, in this case, they must meet the obligations required under each role and be able to demonstrate compliance to the requirements.
Can the same natural or legal person assume the role of importer as well as distributor for one individual device under the MDR/IVDR?
No, because of the very definition of the role.
The distributor is “any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”.
Is an operator who assembles a system and procedure pack (SPP) in accordance with MDR Article 22(1) or (3) using devices from a third country manufacturer (not yet placed on the Union market), considered an importer?
The System/Procedure Pack Producer will be considered the importer if they are the entity first placing the individual devices contained within the System/Procedure Pack, onto the Union market. As such, they would need to fulfill the obligations under Article 13 of the MDR.
Is an operator who assembles a system or a procedure pack (SPP) in accordance with MDR Article 22(1) or (3) using devices already placed on the Union market, considered a distributor?
Yes, if the individual devices within the System/Procedure Pack have already been placed on the Union market, then the System/Procedure Pack Producer will be considered the distributor of those individual devices. As such, they must fulfill the obligations under Article 14 of the MDR.
Can leasing companies be considered importers or distributors under the Regulations?
It is possible, depending on the specific activities they carry out, related to placing on the Union market or making available a device.
Modified Q&As
What is meant by ‘accompanying documentation’ under Article 13(3) of the Regulations?
To better ensure that the importer’s details reach the end user, the Q&A has been updated to advise:
- The importer should consider providing the accompanying documentation with the smallest sealable package of the device, i.e., the smallest packaging that can be purchased by the end user.
- Where the device is delivered in multiple boxes due to its size or configuration, the accompanying document may be provided once, rather than on each individual box, as long as is supplied to a single user or location. This applies exclusively to devices delivered to a single user or healthcare facility.
Article 13(2) and 14(2) of the Regulations set out various verification obligations for importers and distributors. How can these checks be performed?
The MDCG notes that physical checks of the products are essential for ensuring device compliance, detecting non-compliance, and preventing such non-compliant devices from being made available on the market.
If the distributor cannot perform a physical check to verify that the importer’s details have been provided with the device, without compromising the integrity of the packaging or compliance of the device, then in exceptional cases, the verification can be based on documentation checks.
Importers and distributors should be able to demonstrate to the Competent Authority that the verifications have been carried out. And further note that if some of the verification was outsourced to a subcontractor, that does not absolve the importer/distributor from its legal obligations.
Do importers and distributors have any obligations with regards to device traceability?
The answer in the original version of MDCG 2021-27 was “yes”. The new revision goes on to clarify that traceability may be achieved through adequately detailed records in relation to sourcing and supply of medical devices.
The guidance additionally points out that importers and distributors must store UDIs for class III implantable devices and the devices, categories, or groups of devices determined by a measure referred to in MDR, Article 27(11)(a) and devices, categories, or groups of devices that may be determined by a measure referred to in IVDR, Article 24(11)(a), for which they have supplied or with which they have been supplied.
Further Reading
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