The "new" Medical Device Regulation: a stress test for the medical device industry
Due to the coronavirus, the medical device industry has been granted an extended transitional period with regard to the entry into effect of the MDR. However, some in the industry believe that this extension is not really long enough for companies to conform with the MDR in light of the challenges associated with coronavirus.
One problem facing manufacturers of Class 1s and 1m devices and devices in higher risk classes relates to the interpretation of Article 120 of the MDR, under which devices which were manufactured in conformance with the Directives but for which valid certificates were not issued by notified bodies prior to the MDR's effective date, 26 May 2021, may continue to be placed on the market and sold provided they undergo no significant changes in the time since the MDR took effect. The question as to how the phrase "significant changes in the design and intended purpose" is to be understood in any individual case is already the subject of intense discussion among manufacturers and notified bodies.
What is clear, and this is especially true for Class I devices, for which Article 120 of the MDR does not apply - is that the requirements in the MDR should now be considered binding for medical devices which are placed on the market for the first time. Particular attention should be paid to the following aspects, where the rules established by the MDR are stricter than before:
- proper classification of devices in accordance with the MDR's strict classification rules;
- ensuring that the general safety and performance requirements set out in Annex 1 of the MDR are met (including IT security and data protection requirements) in some cases including harmonized standards and common specifications;
- preparing a clinical evaluation;
- preparing technical documentation;
- preparing instructions for use and label;
- establishing a QM system;
- availability of a person responsible for regulatory compliance in accordance with Article 15 of the MDR;
- registration of devices and manufacturers in the EUDAMED database, where possible;
- implementing a post-market surveillance system, including a periodic reporting system (PMS, PSUR);
- implementing a vigilance system for the reporting of "field safety corrective actions."
In addition to complying with the MDR, companies will also have to keep in mind that national rules may also change as the MDR takes effect. In some cases, requirements for manufacturers, importers and distributors under national law will be even stricter than those which were originally set down in the MDR.
Conclusion and Recommended Action
Manufacturers whose devices still have valid certificates in accordance with the Directives should seek to obtain clarity as to residual periods and as to the limits and meaning of the sell-off provision. With respect to the placement on the market of new devices and Class I devices, the MDR's requirements as well as the national rules should be heeded by manufacturers, importers and distributors alike.