Does the European Commission have time to implement any further changes, delay the Date of Application, or will the IVDR be arriving in its current state?
The IVDR Date of Application (DoA) on 26 May 2022 is fast approaching, with less than one week to go at the time of writing. At present, only 10-20% of all in vitro diagnostics (IVDs) under the current In Vitro Diagnostic Medical Devices Directive (IVDD) are subject to Conformity Assessment by a Notified Body (NB). From the DoA, it is widely accepted that 80-90% of IVDs will require a Conformity Assessment by a NB.
Industry bodies such as the European Federation of Pharmaceutical Industries and Associations (EFPIA), together with the European Cancer Patient Coalition, warned the European Commission (EC) some time ago about the IVDR’s shortcomings, especially a lack of NB capacity and the estimated 700% increase in the IVD assessment workload. As we wrote in June last year, EFPIA was particularly concerned that the lack of NBs to complete Conformity Assessments would cause a significant reduction in the availability of vital biomarker testing for cancer patients. EFPIA was not alone in its concerns then, and it is not alone now: as we have written previously, MedTech Europe (the European trade body for MedTech) has published alarming statistics based on a survey of its members which indicates that a huge proportion of existing IVDs may come off the market as a result of the IVDR, and BVMed and SNITEM (the German and French trade bodies for MedTech) have been extremely vocal as well. As it stands, only 7 NBs have been designated under the IVDR with less than one week to go before the DoA – compared with the existing 19 NBs under the IVDD regime – which strongly suggests that these concerns will prove to be justified.
The MDR was delayed, why not the IVDR?
As a result of fears about the impact of the IVDR, both BVMed and SNITEM call for the EC to postpone the IVDR DoA by at least two years. This would be popular in the MedTech industry: more NBs could be designated, more conformity assessments could be conducted in advance, and manufacturers would have longer to plan their reliance on the IVDR transitional provisions. Such a step is not unprecedented: the original Date of Application of the Medical Device Regulation (MDR) was postponed from May 2020 to May 2021. We can look back to that experience to try and gauge how feasible a postponement of the IVDR DoA might be now.
Faced with ever-present concerns about a lack of Notified Bodies, the disruption caused by the COVID-19 pandemic, and calls from MedTech Europe to pause the implementation of the MDR and the IVDR, the EC announced on 25 March 2020 that work was underway on a legislative proposal to postpone the Date of Application of the MDR by one year. The prospect of a medical device shortage during a pandemic, due to increased conformity assessment requirements and a reduction in the number of NBs, was enough to mobilise the EC to action. The resulting legislative proposal passed through the European Union legislative procedure in under a month and became law on 24 April 2020, pushing back the Date of Application to 26 May 2021 – just over a month before its original Date of Application on 26 May 2020.
Although the MDR postponement passed exceptionally quickly, it still took a month to go from being a proposal to being adopted into law. Today, the EC has less than one week left to implement any legislative measures to delay the IVDR DoA. Even if there were a legislative proposal in the works (and we have seen no evidence of such a proposal), this timeline would be more or less impossible to work with.
Another factor to consider is that the EC has already made changes to the IVDR transitional periods in response to industry’s concerns about the impact of the IVDR. As we wrote at the time, the EC brought out a legislative proposal to amend the IVDR in order to introduce lengthier and tapered transition periods for existing IVDs, giving those IVDs more time to remain on the market under the IVDR before they need to obtain a Conformity Assessment. This proposal became law on 20 December 2021 – a welcome Christmas present.
On the one hand, that could be seen as an indication that the EC is willing to take radical legislative measures of this sort to help industry adjust to the IVDR. However, based on the lack of action since then, it now seems likely that the EC believes it has already done enough to smooth out the transition to the IVDR, and there are no last-minute delays inbound.
Union-wide derogations – a last-minute saving grace?
As we discussed in our last article, there are provisions in the IVDR which allow a manufacturer to seek special permission from a National Competent Authority to place an uncertified IVD on the market for a period of time. The IVDR refers to this as a “derogation from the conformity assessment procedures”, but we prefer to call it a ‘period of grace’ (which is much snappier). Such ‘periods of grace’ could be used to provide much needed relief for manufacturers facing the current Conformity Assessment backlog by allowing them to keep existing, technically non-compliant IVDs on the market until such time as they can complete a Conformity Assessment with a Notified Body.
However, National Competent Authorities can only grant ‘periods of grace’ in respect of the Member State territory for which they are responsible. ‘Periods of grace’ only provide a useful temporary alternative to Notified Body Conformity Assessment when they are extended across the whole EU market. Under the IVDR, that requires the intervention of the EC.
As we wrote in our previous article, we have yet to see any evidence of the EC extending ‘periods of grace’ granted by National Competent Authorities under the MDR. We also have not seen any indication from the EC that it intends to make use of the ‘periods of grace’ regime to compensate for the present lack of Notified Body capacity after the DoA.
Given the apparent lack of utilisation of ‘periods of grace’ under the MDR, it is hard to see them becoming particularly prevalent under the IVDR. That being said, impact of the MDR was somewhat ameliorated by the a one year postponement to its Date of Application, which now appears to be out of the question for the IVDR. The EC may have to employ yet more radical measures if the IVDR does prove to be catastrophic for the IVD supply chain.
If so, we may see EU-wide ‘periods of grace’ becoming a viable option for keeping the European MedTech industry on its feet.
Missed out? Read the other articles in this Spotlight on IVDR series:
- Spotlight on IVDR – Cheers Slovakia! Seventh Notified Body designated under IVDR
- Spotlight on IVDR – Why we keep banging on about Notified Bodies
|Now that the IVDR is applicable, we will be publishing more articles taking a closer look at the possible impact of this revolutionary piece of legislation. We will be covering the challenges which adapting the new legislation will pose, the steps that regulators might consider to ease the burden on the MedTech industry, and any lessons that might be learned from the rollout of the MDR which took place one year ago. Watch this space.|