New MDCG guidance offers QMS roadmap for device repackaging, relabeling

Regulatory NewsRegulatory News | 24 August 2021 |  By 

Notified bodies who certify quality management systems related to device repackaging and relabeling have new guidance from the European Commission’s Medical Devices Coordinating Group (EC’s MDCG).
The guidance covers activities conducted under Article 16(4) of the Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR) related to repackaging and relabeling of medical devices. The overall goal of the notified body’s certification activities under this provision is to “preserve the original condition of the device,” and to ensure that the device’s repackaging is of high quality, wrote MDCG.
“However, such certification activities to be performed by them are not related to conformity assessment activities carried out to certify manufacturer’s devices according to either Article 52 of the MDR or Article 48 of the IVDR,” which address device conformity assessment, according to the introduction to the new guidance.
The quality management system for repackaging and relabeling should make clear that manufacturers must inform distributors and importers about any corrective actions the manufacturer has taken. Also, the contract that the distributor or importer enters into with the notified body should specify that the notified body may perform on-site audits as needed.
The guidance outlines the minimum components of the quality management system, which should cover documentation, including how policies and procedures are to be developed; how resource management and sub-contracting will be handled; details of how all parties will be notified of any corrective actions required; and how corrective actions will be handled.
A quality management system must also address traceability issues, document and record control, and provisions for internal audits and management review of the quality management system.
The guidance also outlines parallel procedural and record-keeping requirements for notified bodies conducting certification activities under Article 16(4) of the MDR/IVDR. These include establishing qualification criteria and maintaining appropriate documents and records for all personnel involved; identifying “sufficiently detailed” procedures for conducting the full scope of assessment and certification work; establishing procedures for changes and extensions of certification; ongoing surveillance activities to ensure compliance; and mapping out procedures for re-certification, complaints, and appeals.
The guidance gives minimum requirements for data to be included in certificates issued under Article 16(4); these certificates should be valid for no more than 5 years.
Initial certification “should always include an on-site audit,” according to the guidance, which gives options for duration of certificate validity depending on the results of the notified body’s risk assessment.
Finally, the guidance covers how notified bodies should address any plans for change that might affect the validity of the certificate under Article 16(4), bearing in mind that some changes might mean that the initially certifying notified body is not designated for the new activity.

The guidance makes clear that notified bodies certifying certifying quality management systems for distributors and importers who conduct repackaging and relabeling activities must be designated for the type of device they are certifying.
“A separate MDCG guidance document, in the form of Questions & Answers, is being developed to complement and address implementation of other relevant requirements for distributors and importers introduced by Article 16 of MDR / IVDR,” wrote MDCG in the guidance.


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