European Regulators Offer New MDR Compliance Guidance For Legacy Medical Devices

NEW IDENTIFIERS FOR THE LEGACY DEVICES

EU MDR compliance for legacy devices describes that the legacy devices will not have the same previously assigned UDI-DI instead will have EUDAMED-DI which is same as UDI-DI and EUDAMED IDwhich is same as UDI-DI.

A NEW GUIDANCE ON EU MDR COMPLIANCE FOR LEGACY MEDICAL DEVICES

The European Commission’s Medical Device Coordination Group (MDCG) ‘s has put forth a new guidance that describes the implementation and application of MDR requirements for legacy devices and the devices placed in the market before 26 may 2021.The MDGC had set up ad hoc task- force for applying transitional provisions to the legacy devices and devices placed in the market before 26 may 2021 mentioned in第120条(3)的监管(欧盟)2017/745 (MDR)

MDGC 2021-25 distinguished medical devices into two categories

• Legacy devices:these are the Class I sterile, Class I measuring, Class IIa, IIb, III (medical devices) or active implantable medical devices which have valid CE certificates and were in the European market after 26thMay 2021.
• Old devices: these are medical devices which have valid MDD or AIMDD certificates and were in the European market before26thMay 2021.

The guidance describes the three important topics that is application of:

1. Chapter VII of regulation of EU 2017/745 on medical devices (MDR) to ‘legacy devices’
2. Other EU MDR requirements to ‘legacy devices’
3. EU MDR requirements to ‘old’ devices

REQUIREMENTS SET OUT IN CHAPTER VII OF THE MDR

The MDR chapter VII has set out all the relevant requirements on post market, post-market surveillance, market surveillance and vigilance which applies to the legacy devices. According to article 120(3) the notified bodies should consider the appropriate surveillance or the new requirement applied to the manufacturers of legacy devices from the transitional provisions.Legacy devices need to fulfil the requirements laid down in article 85 and article 86 according to their classification with respect to MDD. The change made in the risk class under MDR should be taken into consideration during the transition period. Active implantable devices subjected to AIMDD are considered as Class III for the sake of applying new MDR during transitional provision.

Article 86 MDR explains the periodic safety update report (PSUR). The manufacturers of legacy devices need to update PSUR according to Article 86 MDR and make PSUR available to competent authorities on request also outside EUDAMED. The notified bodies should check whether the manufacturers have made necessary adjustments according to the new MDR on PMS (post market surveillance) and vigilance. The manufacturers need to make available the PSUR’s to the notified bodies in the manner of surveillance audits so as to allow the notified bodies to verify approved quality system so that the design complies to the certificate issued by the MDD or AIMDD.

OTHER MDR REQUIREMENTS TO ‘LEGACY DEVICES’

In addition to Chapter VII, the other MDR needs to be applied to ‘legacy devices’ only to those whose requirements relate to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices.The manufacturers and importers are generally obliqued to comply with MDR (Articles 10(1) and 13(1) for legacy devices,

The EU MDR guidance on compliance of legacy devices states that MDR requirements that have no relation with post-market surveillance, market surveillance, vigilance, registration of economic operators and devices are not liable to apply to economic operators in respect to ‘legacy devices.

NEW REQUIREMENT FOR OLD DEVICES

According to the task force the MDR requirements are not applicable to the old devices but the rights and obligations of the competent authorities laid down in Articles 93 to 100 MDR with respect to market surveillance also apply to the old devices. This helps competent authorities to monitor devices and are in compliance with rules at present and also necessary actions are taken against unsafe devices.

CONCLUSION

MDCG has issued new guidance in order to help the manufacturers of legacy devices to classify their devices according to MDR prior to their placement in the market in the European Union .According to new guidance on EU MDR compliance for legacy devices, the legacy devices need to comply the requirements based on their classification in the MDD instead of MDR. Active implantable devices under AIMDD should be considered as Class III devices for the reason to apply MDR requirements for the legacy device during the transition period. Under the requirement of MDR compliance the makers of legacy devices need to update periodic safety update reports (PSURs). These reports are needed to be made available to the notified bodies and competent authorities during the audits. For the older devices i.e., one placed in the market before May 26, 2021, though the guidance does not apply to old devices but the competent authorities need to check conformity of devices with the rules applicable at present.The medical devices covered under MDR compliance will need to have a Clinical Evaluation Report (CER) or conduct a Clinical Investigation in order to keep up to date post CE marking of the device. The manufacturers holding Valid MDD CE marking certificate can continue to market their device in Europe until the certificate expires or till May 2024.