Europe’s MDCG offers guidance on legacy medical devices, repackaging

Regulatory NewsRegulatory News
| 22 October 2021 | By Mary Ellen Schneider 

A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices and devices placed on the market prior to the 26 May 2021 MDR rollout.
 
In the guidance, MDCG takes the position that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The surveillance of legacy devices by notified bodies is basically a continuation of the previous surveillance activities under the Medical Devices Directive (MDD)/Active Implantable Medical Device Directive (AIMDD), the guidance notes. MDCG also calls for “flexibility” regarding the notified bodies involvement in surveillance as they are not the same notified bodies involved in the MDR’s conformity assessment procedure.
 
Finally, legacy devices are subject to requirements based on their classification in the MDD, not the MDR. “A possible change of their risk class under the MDR should not be taken into account during the transition period,” the guidance states. “Active implantable devices subject to the AIMDD should be considered as class III devices for the purpose of applying the relevant MDR requirements during the transition period.”
 
Manufacturers of legacy devices are also subject to the requirement to draw up and update periodic safety update reports (PSURs) under the MDR. These reports should be made available to competent authorities on request and to notified bodies as part of surveillance audits.
 
For older devices that were placed on the market prior to 26 May 2021, the guidance states that MDR requirements “are in principle not applicable.” However, the market surveillance activity requirements of the MDR do apply to “old” devices. “This allows competent authorities to check that those devices are in conformity with the rules applicable at the moment when they were placed on the market and to take appropriate measures against non-compliant or unsafe devices,” the guidance states.
 
MDCG has already issued guidance to help manufacturers classify their devices under the MDR before they are placed on the market in the European Union (RELATED: New MDCG guidance shows how devices fit into MDR’s classification rules, Regulatory Focus 06 October 2021).
 
Repackaging, relabeling answers
 
In a separate Q&A document, MDCG outlined regulatory obligations for medical devices and in vitro diagnostic (IVD) medical devices related to repackaging and relabeling.
 
For instance, the document clarifies that MDR and IVDR regulations on repackaging do not apply to situations in which a hospital or health care institution split up a large pack of devices to distribute within their institution.
 
Similarly, it is not considered relabeling and repackaging if the distributor splits up larger quantities of devices into smaller quantities for further supply in the distribution chain, provided that the outer packaging of the device is not affected. For instance, a distributor may receive a large quantity of syringes and split them into smaller packages for use in vaccination centers, according to the Q&A document.
 
Other topics addressed in the Q&A include:
  • The type of information that importers and distributors should provide to manufacturers about relabeling/repackaging activities
  • The type of information that should be communicated to the competent authority by importers and distributors performing relabeling/repackaging activities
  • The role of the notified body in reviewing relabeling/repackaging activities performed on Class I devices and class A IVD devices
  • Instances in which the importer or distributor can provide additional information concerning the batch number when performing relabeling/repacking activities
MDCG legacy device guidance

MDCG Q&A on repackaging and relabeling
 

 

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Tags: EU, IVDR, labeling, MDCG, MDR

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