"S" is for scope: does that include to 'enhance'?

EU flagThe scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal.

From compensation to enhancement

With more and more developments in bionic enhancements for humans becoming available, there is a tendency for products that could be used to remedy, compensate or alleviate handicaps or injuries to convergerge into enhancements to the human physiology, and perhaps – if you are a Ray Kurzweil fan like I am – for mental augmentationas well. A nice example is this bionic ear, which would compensate quite nicely for a lost ear, but which would also make a very nice enhancement because it allows you to hear a lot better than with a normal, healthy ear. Or how about some ocular implants that allow you to see in other visual spectra than the normal, like infrared or X-ray? I’m sure there are special forces guys that would find it very convenient to be able to see in the dark and look through walls. I myself would like to be able to combine the brute serial calculation power and storage capacity of traditional computers with the associative parallel processing that the human mind enables. That would be awesome! If we believe Ray Kurzweil implants for this purpose should become available in the near future (2029). I would love to be able to do really fast complex calculations and carry all my digital files around in my own head.

How to regulate?

How to regulate these types of enhancements that are not medically indicated because the persons requesting them are perfectly healthy? We had this problem in the EU with cosmetic implants (not breast implants, they have their own classification directive and already were medical devices) that people wanted implanted to look more like a klingon, for example. These products have a risk profile that is very similar – if not identical – to medical devices, so why not regulate them as such? This is exactly what the EU is doing with the current proposal for the medical devices regulation, by providing in the article on definition of medical device:

“The implantable or other invasive products, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.”

Annex XV contains a list of products that are regulated like medical devices, even if a ‘medical’ reason for using them is absent. This annex can be updated by means of delegated act (article 2 (2) of the proposed medical devices regulation), as to allow new products to be placed on the list without having to go through a full-blown legislative procedure that would otherwise be required.

Currently, the proposed regulation lists the following products:

1. Contact lenses;

2. Implants for modification or fixation of body parts;

3. Facial or other dermal or mucous membrane fillers;

4. Equipment for liposuction;

5. Invasive laser equipment intended to be used on the human body;

6. Intense pulsed light equipment.

New borderlines and legal recourse

The EU will create a flexible way of regulation these types of products. However it will create a new border area (a borderline does not exist, because that concept assumes clear demarcation criteria – which do not exist in practice). Where there are borderlines there are differences of opinion, and where we see those there are ensuing disputes. Naturally, as lawyer I am curious about protection of the rights of companies that may see products placed on the Annex XV list, just like you could currently end up in the Borderline and Classification Manual, without any formal recourse possible against the MDEG’s decision to put the product in it under a specific qualification. What if a company finds that its products are suddenly on the Annex XV list? With a delegated act being an EU institutions legal act, recourse against it should be possible under article 263 TFEU, right? Well, not so fast. Article 263 (4) TFEU provides that:

 “Any natural or legal person may, under the conditions laid down in the first and second paragraphs, institute proceedings against an act addressed to that person or which is of direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.”

This provision addresses two types of acts that the so-called “non-privileged applicants” can challenge:

  1. the instruments that are de facto decisions (could be challenged under old article 230 EU)
  2. regulatory acts which are of direct concern to them and does not entail implementing measures (new under Lisbon Treaty)

There are two problems here: de facto decisions are notoriously difficult to challenge (as witnessed by a long line of case law showing how difficult it is to prove the direct and individual concern needed for a de facto decision that can be challenged as non-privileged applicant) while delegated acts to fill in Annex XV seem to be regulatory implementing measures, which are similarly difficult to challenge as the ongoing Seals Products cases show, which are the first about the interpretation of this new concept of regulatory act. This leaves undertakings that see a class of products added to annex XV with no serious option for legal recourse, because national courts will not be able to rule on the contents of the Annex XV list, but only on whether a particular product fall within a category on that list. The only viable solution is to make sure that the companies concerned manage to lob a product of off a proposed draft delegated act list seeking to amend Annex XV by lobbying pro-actively.

Alternatively

There are other instruments in the proposal to determine if a product is a medical device. Article 3 (1) of the proposal provides that

“The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘medical device’ or ‘accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).”

This also allows companies to address the Commission to lobby it into instituting an implementing act to the effect that their product or the category it falls in is not a medical device. That happens by implementing act, which may directly concern a company depending on how specific it is, which will impact on legal recourse. In any event, also on this point we can expect litigation with varying degrees of success, as the colleagues of Covington & Burling also predict.

 RIsk/benefit?

 There is one big setback about this way of regulating these enhancements – as well as cosmetic implants, by the way – as medical devices. As the regulation proposal is currently drafted it requires a positive risk / benefit outcome for medical devices and therefore for enhancements and cosmetic devices on the Annex XV list because they are considered medical devices. And this is where we break new regulatory ground: how will you prove that the risks associated with enhancements related procedures and use (cosmetic or performance wise) are outweighed by the benefits, in other words “that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety”? With ‘normal’ therapeutic medical devices there is the benchmark of normal human healthy performance, but this is not possible with enhancements so it is very difficult to demonstrate as there is no standardized methodology for this. Companies will have to follow the standard tech file pathway but need to find a way to tweak the intended use in a way that for that use there is a positive risk/benefit outcome. I expect a firm bias on the side of very cautious on the part of notified bodies with respect to risk/benefit outcomes for new enhancements, provided that the really interesting ones make it to the Annex XV list in the first place. Because delegated acts are proposed by the Commission but normally prepared by member states civil servants in Expert Groups  used by the Commission and member states have a say about delegated acts via the Council, you can bet that only politically uncontroversial products (read: products member states mostly agree about) will be on the Annex XV list.

Consequently

There will be companies wanting to be on the Annex XV list (to make their implants legal) and companies lobbying to stay off it, but the regulatory process will be difficult and predominantly driven by the member states, with no effective legal recourse. Just like with the current borderline process in the Medical Devices Expert Group on Borderline and Classification under the Helsinki procedure- congratulations, we have made a new procedure but have made no progress.


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