Legal recourse against delegated and implementing acts in the medical devices regulation
This time I’d like to entertain you with some aspects of some of the dryest matter that I work with as lawyer: technical rules regarding competence and standing under EU law. However, this subject matter is very important for medical devices companies in the light of the large number of delegated and implementing acts for which the new regulations for medical devices and IVDs make provision, as I have already mentioned.
Eucomed and COCIR spot on
Eucomed was spot on with respect to the Commission’s broad license to legislate this way in its position paper about the revision of the medical devices directives:
“The Commission has proposed more than fifty delegated and implementing acts, which will not be developed before the final approval of the Regulation. Industry believes that many of these acts afford the Commission too broad a mandate or lack sufficient detail to ensure a stable and predictable legal framework for economic operators. In addition, there is a complete lack of a mandatory consultation with stakeholders (patients, doctors, industry) in the elaboration and adoption of these acts.”
Also COCIR expressed the same grave concerns in its position paper, spot on as well as to the possibilities for the Commission to move goalposts around under the proposed regulation for medical devices.
Other EU ‘modern’ EU legislation, like the General Data Protection Regulation (currently in the works and not making life easier on the medical devices industry (see also here, here and here too) either) suffers from the same problem as was even pointed out by the Article 29 Working Party, which is normally very pro more regulation in that field.
Overview
We have had our excellent trainee Arber Gjunkshi (he’s in the market in the near future in case you need a good in-house lawyer – let us know if you’re interested) make the below overview of all the legislative and implementing acts in the medical devices regulation proposal (I’ll refer to that without taking any proposed ENVI amendments into account for the moment) and had him run some legal analysis on what we predict the legal recourse of companies to be. We did not do this for the IVD proposal yet, but the method, outcome and conclusions reached in this blog post are similar under that draft regulation.
Below are three convenient tables to get a handle on the delegated and implementing acts in the draft medical devices regulation. To explain the difference between the 40 measures we counted and the 50 to which Eucomed refers in their position paper: some articles in the draft regulation contain an extra delegated or implementing act procedure in case of emergency for the same subject matter. We did not count those separately, so we arrived at a lower total number, arranged by subject matter rather than the number of instances of possible exercise of delegation.
Table 1: Articles pursuant to which the Commission may adopt implementing acts.
|
No |
Article |
The Commission may adopt implementing acts in: |
|
1 |
3(1) |
determining whether a specific product/a category or group of products falls within the definition of “medical device” or “accessory to a medical device” |
|
2 |
7(1) |
adopting the common technical specifications (CTS) in respect to requirements set out in Annex I |
|
3 |
15(4) |
establishing and updating a list of categories/groups of single-use devices for critical use |
|
4 |
26(2) |
setting out the form and the presentation of the data elements to be included in the summary of safety and clinical performance |
|
5 |
27(7) |
lay down the modalities necessary for the development and management of Eudamed |
|
6 |
32(7) |
setting out modalities for the application for notification referred to in Article 31 |
|
7 |
33(4) |
setting up a list of codes and corresponding types of devices to define the scope of notified bodies` designation which the MS shall indicate in their notification |
|
8 |
37(3) |
suspending, restricting or withdrawing the notification of a notified body |
|
9 |
41(3) |
deciding on the application of the classification criteria set out in Annex VII to a given device/category or group of devices |
|
10 |
42(10) |
specifying procedural aspects for ensuring harmonized application of the conformity assessment procedures by the notified bodies for the relevant points under Article 42(10) |
|
11 |
44(5) |
specifying categories or groups of devices of class III, to which Article 44(1-4) shall apply for during a predefined period |
|
12 |
44(8) |
specifying procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment |
|
13 |
47(3,I) |
extending the validity of an authorization granted by a MS |
|
14 |
47(3,II) |
under urgency circumstances, adoption of an immediately applicable implementing acts |
|
15 |
48(2) |
establishing a model for certificates of free sale taking into account international practice |
|
16 |
60 |
setting the procedural aspects of necessary for the implementation of Chapter VI of the Proposal with regard to letters (a) to (f) |
|
17 |
66 |
setting the procedural aspects of necessary for the implementation of Articles 61 to 65 with regard to letters (a) to (d) |
|
18 |
71(1) |
deciding whether or not the relevant national measures are justified |
|
19 |
71(2) |
taking the duly and justified measures to ensure protection of health and safety, including measures restricting or prohibiting the placing on the market and putting in the service of the devices referred to in Article 70 and 72 |
|
20 |
71(3) |
on duly justified grounds of urgency with regard to Article 71, paragraph 1 and 2, shall adopt immediately applicable implementing acts |
|
21 |
72(3) |
evaluating whether or not the national measures, with regard to compliant devices presenting a risk to health and safety, are justified. |
|
22 |
74(3, I) |
evaluating whether or not the national measures, with regard to preventive health protection measures, are justified |
|
23 |
74(3, II) |
adopting the immediately applicable implementing acts related to Article 74(3,I) |
|
24 |
81(1) |
designating one or more EU reference laboratories for specific devices/category or a group of devices, or for specific hazards related to a category or group of devices |
|
25 |
81(4) |
adopting the modalities and the amount of the grant of a Union financial contribution to EU reference laboratories |
Table 2: Articles pursuant to which the Commission may adopt delegated acts
|
No |
Article |
The Commission may adopt delegated acts in amending / supplementing: |
|
1 |
2(2) |
the list in Annex XV |
|
2 |
4(5) |
the general safety and performance requirements set out in Annex I |
|
3 |
8(2) |
the elements in the technical documents set out in Annex II |
|
4 |
17(4) |
the minimum content of the EU declaration of conformity set out in Annex III |
|
5 |
24(7) |
with regard to letter (a) to (d) of Article 24(7) |
|
6 |
25(7) |
the list of information to be submitted as set out in Part A of Annex V |
|
7 |
29(2) |
the minimum requirements of in Annex VI |
|
8 |
40(2) |
setting out the structure of the level of the fees referred to in Art 40/1 |
|
9 |
41(4) |
with regard to letters (a) and (b) of Article 41(4) |
|
10 |
42(11) |
the conformity assessment procedures set out in Annexes VIII to XI |
|
11 |
45(5) |
the minimum content of the certificates set out in Annex XII |
|
12 |
51(7) |
the requirements for the clinical investigation that is laid down in Chapter II of Annex XIV |
|
13 |
53(3) |
determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the EU database for clinical trials on medical products for human use |
|
14 |
74(4) |
taking the necessary and duly justified measures with regard to Article 74 |
|
15 |
81(6) |
With regard to paragraphs (a) and (b) of Article 81(6) |
If we distill from these tables the measures that may affect companies directly, e.g. because their product ends up on the Annex XV list or is qualified as medical device by the Commission, that produces the following table:
Table 3: the Commission`s delegated and implementing acts, adoption of which might directly affect the concerned undertakings.
|
No |
Article |
The Commission may adopt delegated / implementing acts in order to amend / supplement / or |
|
1 |
2(2) |
the list in Annex XV |
|
2 |
3(1) |
determining whether a specific product/a category or group of products falls within the definition of “medical device” or “accessory to a medical device” |
|
3 |
7(1) |
adopting the common technical specifications (CTS) in respect to requirements set out in Annex I |
|
4 |
15(4) |
establishing and updating a list of categories/groups of single-use devices for critical use |
|
5 |
41(3) |
deciding on the application of the classification criteria set out in Annex VII to a given device/category or group of devices |
|
6 |
44(5) |
specifying categories or groups of devices of class III, to which Article 44(1-4) shall apply for during a predefined period |
|
7 |
71(1) |
deciding whether or not the relevant national measures are justified |
|
8 |
71(2) |
taking the duly and justified measures to ensure protection of health and safety, including measures restricting or prohibiting the placing on the market and putting in the service of the devices referred to in Article 70 and 72 |
|
9 |
72(3) |
evaluating whether or not the national measures, with regard to compliant devices presenting a risk to health and safety, are justified. |
|
10 |
74(3) |
evaluating whether or not the national measures, with regard to preventive health protection measures, are justified; adopting the immediately applicable implementing acts related to Article 74(3,I) |
Legal recourse
So, how about legal recourse against the possible acts in table 3 (or any others that you think should be in table 3)? The Seal Products case that I mentioned earlier has now been decided (see here for the summary in the EU Court’s press release), but it did not really produce the clarity that we hoped to get as a result of the very formalistic way that the Court dealt with the questions in appeal (surprise, isn’t it?). The outcome of the Seal Products case is rather complex, so let me try and explain in a way that I still understand it with a little mind map (with the excellent free mind mapping software Freemind):
In the EU we have a mechanism for legal recourse against EU acts, set out in article 263 TFEU. This mechanism is based on a distinction between so-called ‘privileged applicants’ (e.g. a Member State, the European Parliament, the Council or the Commission) and other applicants (natural persons and undertakings – me and you). Non-priviledged undertakings always had a hard time challenging legislation and other acts of general application, even if it really singled them out individually almost like a decision addressed to the parties concerned, because the EU Court had a very high burden of proof for “direct and individual concern” that had to be demonstrated when challenging anything else than a decision addressed to the party concerned. The reason for that was that the EU considers its rule making of such high democratic quality that it should not be too easy to challenge it in court. There has always been a lot of criticism on the difficulties for non-privilged applicants to challenge EU acts. For that reason, the Lisbon Treaty introduced a more lenient regime in 2009, which allowed non-priviledged applicants to challenge
“an act […] which is direct and individual concern to them, and against a regulatory act which is of direct concern to them and does not entail implementing measures.”
Ergo, persons and undertakings can now challenge a regulatory act which is of direct concern to them and does not entail implementing measures. Consequently, with regard to companies’ recourse against delegated and implementing acts it is very interesting to determine if the delegated and implementing acts under the medical devices regulation are
- a regulatory act; and
- do not entail implementing measures.
Let’s drill down on these two points in the following paragraphs.
Regulatory act
Are delegated and implementing acts adopted under the future medical devices regulation regulatory acts? Well, here comes an answer that lawyers are famous for: definitely maybe. Why so vague? It follows from the Seal Products case that yes, delegated acts and implementing acts adopted pursuant to EU comitology procedures can be regulatory acts, but not necessarily. The AG argues this in a very roundabout way in her opinion (see § 52 and following). Also, this was confirmed in the Microban case, which addressed a pre-Lisbon comitology instrument amending lists regarding permitted food contact materials. But, then there is the next hurdle: the acts should not be implementing measures. But, whether a specific measure can be challenged is something you need to determine on a case-by-case basis.
Implementing measures
Here we are at the last hurdle: the act concerned cannot be an implementing measure. Let’s look at this both for the delegated acts and for the implementing acts separately. The latter category is probably somewhat more of a challenge, if only already because of its name that sort of gives away what it’s purpose is.
What are the delegated and implementing acts intended to do in the regulations? The Commission proposal states in the explanatory text (§ 3.9 on p. 11) that
“The proposal empowers the Commission to adopt, where appropriate, either implementing acts to ensure uniform application of the Regulation or delegated acts to complement the regulatory framework for medical devices over time.”
So, delegated acts complement the regulation and implementing acts … implement? No, implementing acts apparently ensure uniform application, which is something else than implementing I would say. But hang on, there is no case law yet on the meaning of what “implementing measure” in the meaning of article 263 means. Also, there is virtually no literature on the subject either. There is not even that much on the concept of regulatory act in the first place, and that mainly addressed the Seal Products bone of contention whether legislative acts can be regulatory acts.
You see, that’s why I was giving you a definite maybe. While you would expect that a delegated act would not necessarily be an “implementing measure”, there is no way to be sure. The Commission refers to them as “complementing” (rather than implementing) but then it does not call implementing acts “implementing” either (but ‘ensuring uniform application’). This means that we will really have to look at each measure separately with those in table 3 as prime candidates of measures that legal recourse may be possible against. That’s the best I can do at this moment.
What else can you do?
Of course there are other things companies can do. We can hope that the Commission has heard COCIR and Eucomed’s pleas to involve stakeholders in the preparation of delegated and implementing acts. That will also give companies a degree of influence. However, we can’t be sure what degree and whether the Commission will do this. We can’t even be sure if the Commission will adopt any delegated or regulatory acts, because it is not obliged to do so. It may be that we end up with the situation of the medical devices directive, which does have a comitology mechanism but this mechanism never worked very well. For the moment however companies can only lobby when they see a delegated act or implementing acts on the horizon and hope that the Commission will be transparent enough to allow for this.
More insecurity – unless the Commission uses a transparent process
The only conclusion is that there is more insecurity for companies on ex post recourse against delegated and implementing acts and more of an ex ante role for stakeholder organisations to watch what is cooking at the Commission and engage on it in time. Also, stakeholder organisations can play an important role in mobilising and supporting ex post challenges by (groups of) companies to delegated and implementing acts, like e.g. EFPIA routinely does in the medicinal products industry. Of course the Commission, for its part, can greatly reduce insecurity for the industry and for itself by implementing a transparent process with respect to the preparation of delegated and implementing acts and involve stakeholders timely and in a meaningful way. That would also help to manage industry challenging delegated and implementing acts, so the Commission would do itself a big favour too!