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Medical devices authorisations by way of derogation

On 16 February 2023, the Ministry of Health has published the memorandum letter “Operating Procedures for the Application of Authorisation by way of Derogation as per art. 11, comma 3 of Legislative Decree 137/2022”.

The context pushing the Ministry of Health to the publication of this text is well-known for a long time: the risk that, in many cases, the medical device certification process according to Regulation (EU) 2017/745 (MDR) cannot be completed within the expiry date of the certificate released based on Directive 93/42/EEC (MDD), thus making medical devices that are essential for patients’ health unavailable on the market.

This shortage would risk to result in a serious public health issue. There are many causes at the base of this criticality (mainly the Covid-19 emergency and the insufficient number of Notified Bodies designated according to the MDR). In spite of the publication of the position paper MDCG 2022-14, containing a set of actions aimed at limiting the effects of the delayed transition to the new community norms, the problem still persists.

Article 59 of the MDR had already foresaw the possibility of a derogation to the conformity evaluation procedures. With this in mind, Legislative Decree 137/2022, that became effective on 28 September 2022 and containing provisions to adjust national regulations to the MDR, has provided further indications on the procedures for the authorisation by way of derogation by the Ministry of Health for the placing of devices without CE marking on the Italian market.

According to article 11 of this decree, it is provided for that the Ministry of Health can authorise the marketing of devices whose MDR conformity evaluation procedures are not completed, but whose use is essential for public health reasons.

The memorandum letter of 16 February 2023 defines the procedure to follow for this particular case providing operating indications to the interested parties.

First of all, before submitting the official application and before the certificate expiry, manufacturers shall inform the Ministry of Health, the competent regional departments, and the healthcare institutions about the probable future unavailability of the concerned device, and that they intend to apply for an authorisation by way of derogation as per art. 59 of the MDR.

However, a condition required to obtain such derogation will be that the manufacture has started an evaluation procedure with a Notified Body.

Healthcare institutions, informed about the future lack of the device and believing that such lack might cause public health issues, will inform regional departments, that will in turn report this to the Ministry of Health.

Following such reporting, the manufacturer can submit an official application according to the instructions provided in the memorandum letter.

If this application is assessed favourably, the Ministry of Health will release an authorisation (with temporary limited validity and subject to specific conditions) to the manufacturer for the placing of the device on the market.

However, the manufacturer shall comply with all obligations pertaining its legal status and, above all, they shall ensure that the device is placed on the market with appropriate documentation clearly indicating that the device is not CE marked and that is placed on the market only by the virtue of a time-limited authorisation by way of derogation.

The release of the memorandum letter is in line with the orientation of the European Commission, that proposed the extension of the transition period as per art. 120 of the MDR on 6 January 2023.

This proposal has recently recorded a significant step forward from an official point of view. In fact, on 16 February 2023, in a plenary session, the European Parliament has definitely voted in favour of the transitory period extension. Now, everybody is waiting for the adoption of this proposal by the European Council and its following publication in the Official Journal of the European Union.

Written by: Simone Pippa on 21/02/2023

Foto di Bruno /Germany da Pixabay