21 March 2023
Medical Device Regulations – 3 of 3 Insights
The content of this article has been updated to reflect legal changes as at March 2023.
An Article 97 derogation might be used to take advantage of the extension to the Medical Device Directive (MDD) certificate transition periods in the newly extended legislation if an agreement for a conformity assessment for the specific device has not been put in place before expiry of the certificate. See our article, The EU MDR transition times extension explained.
Article 97 of the Medical Device Regulation (MDR) is essentially being varied from its original purpose and mechanism by the MDCG Position Paper. It's now intended to be used in place of Article 59 derogations.
The Position Paper allows manufacturers whose certificates either have expired or which will expire before they receive their notified body certificate under the MDR to make an application under Article 97 of the MDR.
The application is made to the competent authority of the Member State in which the manufacturer or their Authorised Representative has their registered place of business.
That competent authority is required to carry out 'an evaluation' covering all requirements laid down in the MDR relating to the risk presented by the device or to any other non-compliance (under Article 94). If that competent authority determines that the device does not present an unacceptable risk, then the competent authority can apply Article 97 of the MDR, as 'amended' by the Position Paper.
The manufacturer will be required to bring the non-compliance to an end 'within a reasonable and clearly defined period'.
We can help you apply for your Article 97 derogation in whichever country that application is to be made in.
Article 97 will be applied to legacy devices which are subject to the transitional provisions under Article 120(3) of the MDR. These are devices requiring notified body certificates under the MDR.
The manufacturer must have made the application to the notified body under the MDR and it must have been accepted by the notified body and the written agreement signed by both parties per paragraph 4.3 of Annex VII MDR. Competent authorities are permitted to waive this condition for SMEs whose certificate under the applicable directive was issued by a notified body not certified under the MDR and who can show that they have made 'reasonable efforts' to apply to a 'considerable number' of notified bodies and who have not accepted that application. This of course requires written correspondence with such notified bodies, which is not always straightforward to obtain.
The MDD or AIMDD certificate must have been valid at the date of expiry/still be valid. If a certificate has been suspended or withdrawn, then the Article 97 process will not be applied.
The device must also not have undergone a significant change in design or purpose.
If the device is subject to non-compliances other than certificate expiry, it is unlikely that Article 97 will be applied as per the Position Paper, although of course, an actual non-conformance is the situation in which Article 97 is intended to be used in its actual meaning.
The manufacturer must have adapted its QMS to the MDR requirements.
The manufacturer will also need to provide information on incidents and field safety corrective actions and the outcome of notified body audits to date to prove ongoing acceptability of the safety profile of the device.
If granted, the competent authority authorisation remains subject to the discretion of the competent authority who can withdraw it if at any time they consider that the device presents an unacceptable risk.
There will be a standard form communication sent by the competent authority agreeing the Article 97 derogation.
The competent authority will set a 'reasonable period' for compliance, generally not more than 12 months. Given that time periods for obtaining certificates from notified bodies are frequently not reasonable and are longer than 12 months, manufacturers are likely to have to ask and potentially ask repeatedly for extensions, so we hope this will be applied with some flexibility.
The manufacturer will be asked to immediately report 'major shortcomings' identified in the conformity assessment procedure which gives reason to believe that the device may present an unacceptable risk to health and safety. This will require a judgement call given that risks acceptable under the directives might not be considered acceptable under the more stringent requirements of the MDR.
The competent authority can also impose additional conditions on the manufacturer's duty and plan of action to timely obtain their MDR certificate.
The competent authority can request that the manufacturer inform users of the derogation.
The competent authority should inform all other competent authorities of the Article 97 derogation. Nevertheless, the guidance states that other competent authorities can take 'duly justified measures' against other relevant economic operators. One might presume that this is intended to relate to other non-conformities, but this is not clear.
Article 97 of the MDR is intended to apply to devices which are on the market, and which do not comply with the MDR as determined under the market surveillance provisions of Section 3. Manufacturers whose certificates have expired would nevertheless not be advised to continue placing products on the market unless they have confirmation that they might do so from the competent authority. Authorities when requested to grant derogations regularly ask whether the device is currently being placed on the market without a certificate and if they are, have the power to impose civil and/or criminal sanctions.
Equally, if MDD/AIMDD certificates have not expired, then there is no non-compliance to which Article 97 might be applied and using it in this situation is a change to the MDR.
Article 97 of the MDR is also intended to be applied equally across all Member States' competent authorities. As written, any and all competent authorities could take action against non-compliant devices. They could each determine whether the device does not present an unacceptable risk and the actions that they would require and notify the Commission and the other competent authorities of their independently made decision. It therefore remains possible for there to be differential application between countries.
Given that the MDCG guidance represents a clear change in the MDR, the Commission ought to have clarified the legal position by publishing an amending provision to the MDR dealing specifically with the situation.
It is not satisfactory to ask companies to rely on a change in law based on a document that states on the face of it 'The document is not a European Commission document, and it cannot be regarded as reflecting the official position of the European Commission'. However, manufacturers that are out of time for their certification under the MDR have no option but to do so.
Article 59(1) is the originally intended route for derogations. Article 59(1) derogations require that the application is made 'in the interest of public health or patient safety or health'. Most competent authorities are interpreting this narrowly by requiring that there are no alternatives available on the market and that without the device patient health will be compromised. We have been successful in arguing where competing devices are available, that their supply volume is not sufficient to meet demand. We have also successfully argued, for devices intended to operate with an installed base, that it is not financially viable to have hospitals change that installed base. Competent authorities are otherwise generally immune to arguments about pricing or the necessity of competition on the market.
Note that the extension to transition periods does not apply to legacy devices under the In Vitro Diagnostic Directive (IVDD) because there has already been an extension of transition periods from an amendment to the In Vitro Diagnostic Regulation (IVDR) - see here. It remains to be seen whether these extensions will be sufficient.
The equivalent article that might be used in relation to certificates for in vitro diagnostic devices is Article 92 of the IVDR. This is not however included in the MDCG guidance.
9 May 2023
8 December 2022
21 March 2023