problem-solved-spongebobOn 16 March 2020 the Commission published the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat.

While this recommendation has been flagged here and there as ‘this may be important’ without real further comment I have been thinking about this recommendation myself and here is my take on what it means and may lead to.

What is this recommendation about?

Obviously this recommendation is an attempt of the Commission to manage administative barriers to placing PPE (personal protective equipment) and medical devices on the market that would be needed in the struggle to get the current Covid-19 pandemic under control. In my view you can also see this as a template for the next pandemic that has already started to affect the medical devices industry: the bottleneck caused by date of application of the MDR.

Let’s see what the recommendation does: it addresses two kinds of administrative barriers: conformity assessment procedures and market surveillance procedures.

With regard to conformity assessment procedures the recommendation recommends member states to

“the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.”

In other words: please Member States, think about your options to propose national CE marking exemptions for devices that can be transformed into a pan-European measure by means of the article 59 MDR procedure. The Commission cannot take its own initiaves on this point but can recommend the membe states to do this. Article 59 MDR procedure allows the Commission to make measures taken by one member state mandatory for the whole Union, which is a pretty useful feature. If one member state decides to allow a device on the market without CE mark and notifies the Commission, the Commission can validate the exceptionality and need of the measure at Union law and make an implementing act to make the measure mandatory for the whole Union, which becomes applicable after the members states and the EU parliament allow it through the implementing act procedure.

With regard to market surveillance the recommendation recommends member states to:

  1. The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.
  2. Where market surveillance authorities find that PPE or medical devices ensure an adequate level of health and safety in accordance with the essential requirements laid down in Regulation (EU) 2016/425 or the requirements of Directive 93/42/EEC or Regulation (EU) 2017/745, even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalised according to the harmonised rules, they may authorise the making available of these products on the Union market for a limited period of time and while the necessary procedures are being carried out.
  3. PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.

The first point addresses dangerous non-compliant devices. I already see a spike in placebo medical devices and non-compliant Covid-19 self tests of which nobody knows where they come from or whether they even work for this intended purpose. Needless to say, authorities should clamp down on those.

The second point seems to be a reference to the article 97 (3) MDR procedure, under which the Commission can specify appropriate measures by implementing act for devices that are non-compliant administratively but do not present an unacceptable risk to health and safety of patients. This is an interesting procedure because unlike the article 59 procedure it allows for block exemptions.

The third option is also a good option: member states allow devices purchased according to certain specifications for the duration of the health crisis. This works especially well when devices are purchased via tenders.

So this recommendation, if you realize the at the Commission does not have any direct power under the MDR to take emergency measures, is really something. But it can also be a stepping stone for the way the EU handles the consequences of the bottleneck in medical devices approval caused by the way the MDR was set up, and which is now compounded by the Covid-19 health crisis.

What does/could this mean for the MDR and its date of application?

Everybody and their mother wants the date of application of the MDR moved for obvious reasons – with the Covid-19 pandemic happening notified body capacity is collapsing, and manufacturers have facilities closed down so are unable to receive physical audits. Even though everybody does what they can remotely, the processes are even more delayed and are delayed severely. We may not even out of lockdown in many place by the DoA of 26 May 2020.

The DoA, abbreviation for Date of Application, is starting to be cynically used as ‘Dead on Arrival’ by now. The situation is really getting out of control, even if everybody, including notified bodies, are doing their best to keep working the problem.

Yet, there is no mechanism in the MDR for moving up the DoA quickly because the EU is not set up this way. Clamoring for that is therefore not going to work.

A change of the DoA requires a legislative change, which cannot happen quickly. Reopening the MDR would lead to a situation where everybody would propose amendments or disagree, and that would bog down the process even more. Even if everyone agrees and does not propose amendments, the process takes several months. So that won’t work anymore now.

Emergency measures then? Since the EU is not a federation we have not delegated that much in terms of actual decision making power to the EU institutions, especially not in healthcare. The Commission is allowed to propose and the EU may adopt internal market measures that have a health dimension, but it is totally not allowed for the EU to intervene in emergency health situations on its own initiative with binding measures. Member states closely guard their national competence in that field and are not going to hand that over to Brussels. This pandemic shows that doing exactly that may not be such a bad idea – as they say, never waste a good crisis.

All emergency procedures in the MDR therefore start with a member state or an MDCG initiative, which is subsequently made binding by the Commission with an implementing act. The implementing act can always be blocked by member states or the Parliament. So this is how the EU works: nothing happens unless everyone agrees. Usually this works fine. In pandemics, it’s not so efficient.

The only way to move the MDR date of application is to start a new legislative procedure and change the date of application. Nobody wants to start a new legislative procedure at the moment however. Why? Because first, it is a slow process. Secondly, everybody will put in amendments because they can, slowing down the process enormously because nobody is going to agree with the amendments of everybody else just like that.

My thinking is that a version 2.0 of this recommendation would solve a lot of problems, without needing to go through a legislative procedure to amend the MDR. It would be appropriate too, because the Covid-19 pandemic and the date of application overlap and compound issues. Many of the bottleneck problems that we were having already with respect to notified body capacity have been steeply exacerbated by the Covid-19 pandemic.

A new recommendation drafted with the date of application in mind could provide the necessary coordinative template for member states to solve the unavailability of safe devices as a result of administrative problems, because the Commission does not have the power to do this. The recommendation 2.0 would provide a template for concerted and efficient use of the article 59 and 97 (3) MDR procedures. Everybody wins and the patients the most. Would’t that be great?

Again, why not the IVDs?

As we have seen with the Joint Implementation Plan, this Covid-19 recommendation also does NOT apply to IVDs – it only mentions medical devices under the MDD and the MDR. I don’t understand how you can ignore IVDs when the whole healthcare system is complaining about a lack of tests? In any pandemic, access to sufficient relevant tests is vital. I can for the life of me not understand how it is possible to ignore IVDs in this scenario.

Any recommendation 2.0 aimed at fixing the medical devices bottleneck should address IVDs too. The writing is on the wall that the bottleneck will be far worse for IVDs

A little side note on standards

Everybody is frustrated about the delay in harmonised standards for the MDR and IVDR, but this is no reason for delay as such. The recommendation reiterates in recital 18 that

compliance with the harmonised standards is not mandatory. Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the medical device complies with the applicable essential health and safety requirements.”

So, absent the harmonised standards manufacturers must think about what the state of art really is, and how a GSPR can really be met by their solution. Good time to think out of the box. The recommendation impresses in recital 22 on notified bodies to be flexible in this, and not be hung up on standards per se.

So – outlines of a way out

Use the recommendation 2.0 route could be the best compromise under the circumstances – a tried remedy that everyone should be able to live with and has a good chance of solving a lot of problems related to the conformity assessment bottleneck exacerbated by the Covid-19 pandemic. A true European solution! Now we just have to do it.