Together, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) represent the greatest regulatory revolution to hit the MedTech sector in three decades.

At the time of writing, the MDR has been in full effect for nearly a year, and the Date of Application (DOA) of the IVDR is less than two weeks away on 26 May 2022.

Both the MDR and the IVDR significantly increase the level of scrutiny and the quantity of supporting clinical data which is required before a medical device or an in vitro diagnostic medical device (IVD) can be placed on the market in the European Union. They also require existing medical devices and IVDs to undergo new Conformity Assessments in due course if they are to remain on the market.

As we have written many times previously, despite the very short period of time remaining before the DOA, there are only 7 Notified Bodies designated under the IVDR, and the rate at which new Notified Bodies are being designated is extremely slow. Limited Notified Body capacity seriously limits the rate at which Conformity Assessments can be conducted, which in turn may have dire consequences for patient care, as existing IVDs struggle to remain on the market and new, innovative IVDs are held back from launch.

Transitional periods

There is some relief from the Notified Body bottleneck under the IVDR in the form of the phased transition periods introduced by an amendment to the IVDR late last year. As we wrote at the time, these will apply to devices which have undergone Conformity Assessment under the previous regulatory framework before the 26 May 2022.

Nonetheless, it is important to note that manufacturers relying on the transitional periods must comply with the IVDR post market surveillance and vigilance obligations, which will apply to all devices being placed on the market from 26 May 2022. Devices will also cease to benefit from the transitional periods if they undergo a ‘significant change in their design or intended purpose’.

Earlier this month, the Medical Devices Coordination Group (MDCG) published guidance on ‘significant changes in the design or intended purpose.’ Although non-binding, the guidance is relatively comprehensive. Examples of ‘significant changes’ include extending the intended use, changing the intended user, or changing the operating principle. Making small corrections to the product information, limiting the intended use, and any changes that do not alter the operating principle will all be allowed. It is good to see guidance of this sort being released, but it is also disappointing that it has been released in the same month as the IVDR DOA. The industry should have been able to plan its reliance on the IVDR transitional periods months ago.

Periods of grace

For manufacturers which are unable to rely on the transitional periods and cannot obtain an IVDR Conformity Assessment in sufficient time to keep their IVDs on the market, there is still some hope in the form of the ‘periods of grace’ regime. This regime allows manufacturers to approach National Competent Authorities to seek special permission to place an IVD on the market where it does not have a valid Certificate of Conformity from a Notified Body. Such permission may be granted at the National Competent Authority’s discretion if the request is ‘duly justified’ and in the interests of public health or patient safety or health.

Based on guidance from the European Commission on the identical ‘periods of grace’ regime under the MDR, a request is ‘duly justified’ where:

  • The manufacturer has done what can be reasonably expected in order to complete the Conformity Assessment without delay or, where applicable, there is sufficient evidence that the manufacturer has been prevented from completing, or initiating, the Conformity Assessment due to exceptional and unforeseeable circumstances;
  • The medical device concerned is of vital importance relating to public health or patient safety or health;
  • There is a lack of suitable substitutes available;
  • There are no indications in the technical dossier, or from vigilance or market surveillance activities, concerning devices of previous generations or with similar characteristics, that the device could be harmful for patient health or safety or public health; and
  • The period of the derogation is limited to what can be reasonably considered necessary to complete the applicable Conformity Assessment procedure or, alternatively, to ensure patient safety or health or the protection of public health.

Each National Competent Authority can only grant ‘periods of grace’ in respect of the Member State territory for which it is responsible, so the grant of a single ‘period of grace’ will not permit the IVD in question to be sold throughout the EU market. However, each National Competent Authority must also notify the European Commission of any ‘periods of grace’ which it grants, and the European Commission may then choose (in its discretion) to extend the ‘period of grace’ across the entire EU market, allowing that IVD to be sold throughout the EU. In addition to assessing the bullet-pointed factors above to decide whether to grant an EU-wide ‘period of grace’, the Commission will also consider whether there is ‘clear Union relevance for extending the validity’ of the ‘period of grace’ across the EU.

A miracle cure?

As the MDR also faced a severe shortage of Notified Bodies prior to its Date of Application in 2021 (and continues to face such a shortage), one might have hoped to use the experience of the first 12 months of the MDR to gauge whether such ‘periods of grace’ might be a measure routinely used by National Competent Authorities to ensure continuous supply of IVDs following the IVDR DOA. Unfortunately, there is no public register of ‘periods of grace’ granted by National Competent Authorities, and the European Commission does not appear to have adopted implementing legislation to grant any Union-wide ‘periods of grace’. We have also not come across any reference to ‘periods of grace’ being granted in any press releases, so we are unable to draw any conclusions in this regard about the first months of the IVDR based on the transition to the MDR.

Based on the experience of seeking ‘periods of grace’ under the previous regulatory framework, in circumstances where medical devices or IVDs were ‘orphaned’ by their Notified Body, it is unlikely that reliance on a ‘period of grace’ will ever be routine. ‘Orphaning’ occurred where a medical device or an IVD already had a supervising Notified Body, but that Notified Body’s designation under the regulatory framework was withdrawn or expired, leaving the manufacturer of the medical device or IVD in the lurch.

As the Certificate of Conformity for the medical device or IVD was not valid without a supervising Notified Body, manufacturers were forced to approach National Competent Authorities to plead for a ‘period of grace’ to remain on the market while they sought a new Notified Body to take over. We had experience with a number of such ‘periods of grace’, and there was an agreed procedure which all EU National Competent Authorities would follow when deciding whether to grant one, but conditions were always attached, including:

  • Undertaking not to make any significant changes to the device during the ‘period of grace’;
  • Providing the National Competent Authority with monthly adverse event reports;
  • Allowing the National Competent Authority to exercise heightened regulatory scrutiny of the device; and
  • Keeping the National Competent Authority continuously updated on the manufacturer’s efforts and progress towards obtaining a new Certificate of Conformity from a new Notified Body.

The first priority for National Competent Authorities was also always patient safety. A ‘period of grace’ could reasonably be expected if the medical device or IVD was essential to the provision of continuous and high quality patient care, but if healthcare institutions could readily obtain substitute devices without disruption to patient care, a ‘period of grace’ was unlikely to be granted. This is consistent with the European Commission’s guidance on ‘due justification’, so we expect the same will be true if ‘periods of grace’ are sought for existing IVDs which have lost the benefit of the IVDR transitional provisions. If ‘periods of grace’ do start to be granted under the IVDR, it will be interesting to see where National Competent Authorities and the European Commission draw the line between those IVDs whose continued supply is ‘in the interests of public health or patient safety or health’, and those whose supply is not.

As an aside, the MDR and IVDR contain provisions specifically dealing with ‘periods of grace’ in the context of Notified Body orphaning. These provisions contain very little detail which might indicate how readily a ‘period of grace’ might be granted in other circumstances, but we will be keeping an eye out for any guidance from the MDCG on these provisions which might provide a clue.