Order of the President of the General Court of 23 February 2022

Uitspraak

ORDER OF THE PRESIDENT OF THE GENERAL COURT

23 February 2022 (^*)

(Interim relief – Medical devices – Directive 93/42/EEC – Regulation (EU) 2017/745 – Application for suspension of operation of a measure – No urgency)

In Case T‑764/21 R,

Atesos medical AG, established in Aarau (Switzerland), and the other applicants whose names are listed in the annex, (¹) represented by M. Meulenbelt, B. Natens and I. Willemyns, lawyers,

applicants,

v

European Commission, represented by E. Sanfrutos Cano, C. Hödlmayr and C. Vollrath, acting as Agents,

defendant,

APPLICATION under Articles 278 and 279 TFEU for suspension of operation of the unpublished Commission decision, the date of which is unknown, which provides for the expiry of the designation of Schweizerische Vereinigung für Qualitäts- und Management Systeme as a conformity assessment body for medical devices under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1), and its removal from the database of notified and designated bodies with effect from 28 September 2021,

THE PRESIDENT OF THE GENERAL COURT

makes the following

Order

 Background to the dispute, procedure and forms of order sought

1        The applicants, Atesos medical AG and the other legal persons whose names are listed in the annex, are companies incorporated under Swiss law which manufacture medical devices.

2        The conformity of each of those medical devices with the essential quality and safety requirements laid down by Council Directive 93/42/EEC of 14 June 1993 on medical devices (OJ 1993 L 169, p. 1) was assessed by a designated conformity assessment body and certified by that body in the form of CE certificates, which permit the applicants to declare that their products comply with that directive and to affix the CE mark to their respective devices.

3        The designated conformity assessment body in respect of all the devices manufactured by the applicants is Schweizerische Vereinigung fur Qualitäts- und Management Systeme (‘SQS’), a body accredited and designated by the Swiss Government and recognised since 2003 as a notified body under EU law, pursuant to Joint Decision 1/2003 adopted by the European Commission, on behalf of the European Union, and by the Swiss Confederation, under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment (OJ 2002 L 114, p. 369, ‘the MRA’).

4        On 5 April 2017, the European Parliament and the Council adopted Regulation (EU) 2017/745 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ 2017 L 117, p. 1).

5        Regulation 2017/745 harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the EU market, thus allowing them to benefit from the principle of free movement of goods.

6        In accordance with Article 123(2) of that regulation, it should have been applicable from 26 May 2020.

7        In view of the COVID-19 outbreak and the associated public health crisis, its epidemiological development and the additional resources required by Member States, health institutions, economic operators and other relevant parties, the date of application of certain provisions of Regulation 2017/745 was deferred by one year.

8        Thus, pursuant to Article 1(8)(a) of Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation 2017/745 as regards the dates of application of certain of its provisions (OJ 2020 L 130, p. 18), the application of the provisions of Regulation 2017/745 which should have applied from 26 May 2020 was deferred until 26 May 2021.

9        The MRA provides, in Article 1(2), that, in order to avoid duplication of procedures when Swiss and EU requirements are deemed equivalent, the European Union and Switzerland are to mutually accept reports, certificates and authorisations issued by the bodies listed in Annex 1 and manufacturers’ declarations of conformity certifying conformity to their respective requirements in the areas covered by Article 3. Article 3 provides that that agreement covers the obligatory conformity assessment procedures ensuing from the legislative, regulatory and administrative provisions listed in Annex 1 to the agreement and that Annex 1 defines the product sectors covered by that agreement. Chapter 4 of that annex, headed ‘Medical devices’, lists the legislative, regulatory and administrative provisions covered by Article 1(2) of that agreement in respect of that product type.

10      On 26 May 2021, the Commission published a press release on the status of the MRA and a notice to stakeholders informing them that the mutual recognition of medical devices between the European Union and Switzerland had ceased to apply from that date, with the result that trade in those devices would no longer be facilitated. It was stated, in essence, that this was linked to Regulation 2017/745 entering into force on the same date.

11      On 27 June 2021, a pop-up window relating to SQS published by the Commission in the online database of the NANDO (New Approach Notified and Designated Organisations) information system indicated that SQS was allowed to continue its surveillance activities only in respect of beneficiary legacy medical devices.

12      On 5 October 2021, SQS discovered that the Commission had removed it from the webpage of the NANDO information system which lists notified bodies with valid designations and had moved it to another part of that database which lists notified bodies whose designation had been withdrawn, had expired or had been suspended (‘the contested decision’).

13      By application lodged at the Court Registry on 8 December 2021, the applicants brought an action for annulment of the contested decision.

14      By a separate document lodged at the Court Registry on the same date, the applicants brought the present application for interim measures, in which they claim, in essence, that the President of the General Court should:

–        declare the application for interim measures admissible;

–        declare the application for interim measures well founded and order immediate suspension of the operation of the contested decision;

–        order the Commission to pay the costs.

15      By a measure of organisation of procedure of 10 December 2021, the President of the General Court put to the applicants a question to be answered in writing.

16      On 15 December 2021, the applicants replied to the question raised by the President of the General Court.

17      In its observations on the application for interim measures, which were lodged at the Court Registry on 17 January 2022, the Commission contends that the President of the General Court should:

–        dismiss the application for interim measures;

–        order the applicants to pay the costs.

 Law

18      Under Articles 278 and 279 TFEU, read together with Article 256(1) TFEU, the judge hearing an application for interim measures may, if he or she considers that the circumstances so require, order that the operation of a measure challenged before the General Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the General Court or prescribe any interim measures (see order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12 and the case-law cited).

19      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures are to state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measures applied for’.

20      The judge hearing an application for interim measures may thus order suspension of operation of an act and other interim measures if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim measures is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P‑R, EU:C:2016:142, paragraph 21 and the case-law cited).

21      In the context of that overall examination, the judge hearing an application for interim measures enjoys a broad discretion and is free to determine, having regard to the particular circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

22      Having regard to the material in the file, the President of the General Court considers that he has all the information necessary to rule on the present application for interim measures without there being any need first to hear oral argument from the parties.

23      In the circumstances of the present case, it is appropriate to examine first whether the condition relating to urgency is satisfied.

24      In order to determine whether the interim measures sought are urgent, it should be borne in mind that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision in order to avoid a lacuna in the legal protection afforded by the EU judicature. To attain that objective, urgency must generally be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see, to that effect, order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P‑R, EU:C:2016:21, paragraph 27 and the case-law cited).

25      It is in the light of those criteria that it is necessary to examine whether the applicants have succeeded in showing that the condition relating to urgency is satisfied.

26      In the present case, in order to demonstrate that the damage is serious and irreparable, the applicants claim that, as long as the contested decision is not suspended and SQS is not reinstated in the NANDO information system, they are in a situation of critical legal uncertainty that entails significant regulatory and commercial risks, not only causing serious and irreparable damage to their operational, commercial and financial interests, but also endangering the health and lives of patients in the European Union who use, or are treated with, their medical devices. In that regard, the applicants claim that their customers, mainly physicians and hospitals, will have to try and find alternatives to the applicants’ medical devices in order to meet their healthcare needs, including ensuring that patient care is not interrupted.

27      In particular, the applicants submit that the damage is serious because, as the share of their sales in the European Union accounts for up to 95% of their revenue, there is a significant and very real risk that their revenue will be reduced below a vital minimum, that they will be financially ruined or that they will be placed in a position that endangers their very existence or irretrievably alters their position in the market. In addition, the applicants claim that their action corroborates the fact that the damage which they suffer and risk suffering in the future is serious, to the extent that they did not understand why the registration of SQS in the NANDO database was altered. They state that they reacted swiftly, first, by working with SQS, which made contact with the Commission after discovering that it had been removed from the list concerned, and, secondly, by initiating the present proceedings after becoming aware of the Commission’s position.

28      In addition, the applicants claim that the damage is irreparable because, as a result of losing customers on account of the contested decision, they would lose all of their market share in the European Union and, inevitably, the resulting revenue, thereby endangering their very existence. Furthermore, the applicants submit that, even if they obtain a CE certificate under Regulation 2017/745 from a new notified body in the future, it will, once customers have switched from the applicants’ medical devices to other medical device brands, be very difficult, if not impossible, to persuade those customers and their patients to switch back. Lastly, the applicants submit that, even if they were able to survive financially, find a notified body based in the European Union that is able to certify their products under Regulation 2017/745 and have their products CE certified once again, their reputation on the EU market would remain damaged for years.

29      The Commission disputes the applicants’ arguments.

30      In the first place, as regards the applicants’ argument that they are in a situation of critical legal uncertainty that entails significant regulatory and commercial risks, endangering the health and lives of patients in the European Union who use, or are treated with, their medical devices, it should be noted that, in accordance with settled case-law, an applicant may not, in order to establish urgency, rely on damage caused to the rights of third parties or to the general interest (see order of 26 September 2017, António Conde & Companhia v Commission, T‑443/17 R, not published, EU:T:2017:671, paragraph 35 and the case-law cited).

31      In the present case, the applicants rely in that regard on damage which does not affect them personally, since they claim to be in a situation of legal uncertainty liable to endanger the health and lives of patients in the European Union who use, or are treated with, their devices.

32      Thus, the applicants cannot rely, in order to demonstrate urgency, on damage which third parties and entities would suffer.

33      In any event, it should be stated, as the Commission has done, that Article 59(1) of Regulation 2017/745 allows the competent authorities of the Member States to authorise, on a duly justified request, the placing on the market or putting into service of a specific medical device for which the procedures laid down by that regulation have not been carried out but use of which is in the interest of public health or patient safety or health. In addition, under certain conditions, Article 59(3) of that regulation empowers the Commission, in exceptional cases relating to public health or patient safety or health, to extend such authorisation granted by a Member State to the whole of the European Union. According to the information provided by the Commission, it has not received any request to that effect nor is it aware of any such request having been submitted by the applicants to the competent authorities of the Member States.

34      In the second place, as regards the applicants’ argument that, as the share of their sales in the European Union accounts for up to 95% of their revenue, there is a significant and very real risk that they will lose all of their market share in the European Union and, inevitably, the resulting revenue, and that they will be financially ruined, thus endangering their very existence, it should be stated at the outset that the damage relied on in that regard is pecuniary in nature.

35      It is well-established case-law that damage of a purely pecuniary nature cannot, save in exceptional circumstances, justify the award of interim measures, since financial compensation for that damage can normally be obtained subsequently, such exceptional circumstances being established if it appears that, without the measures sought, the applicant would be in a position that could jeopardise its existence before a final decision is reached in the main action. Since imminent disappearance from the market does constitute damage that is both irreparable and serious, adoption of the interim measure sought appears justified in such a situation (see order of 9 June 2010, Colt Télécommunications France v Commission, T‑79/10 R, not published, EU:T:2010:228, paragraph 37 and the case-law cited).

36      In that regard, concerning the seriousness of the pecuniary damage relied on, it is settled case-law that the assessment of the serious nature of such damage must be carried out in the light of, inter alia, the size and turnover of the undertaking and the characteristics of the group to which it belongs (see order of 21 January 2019, Agrochem-Maks v Commission, T‑574/18 R, EU:T:2019:25, paragraph 34 and the case-law cited).

37      It is also clear from case-law that it is for the party seeking interim relief from the judge hearing the application for interim measures to provide essential evidence enabling that judge to establish a true overall picture of its financial situation and that of the shareholders controlling it. That information must, first, be specific and precise and, secondly, be supported by detailed and certified documentary evidence (see, to that effect and by analogy, order of 20 April 2012, Fapricela v Commission, C‑507/11 P(R), not published, EU:C:2012:231, paragraph 35 and the case-law cited).

38      In the present case, the only material submitted by the applicants consists in a number of their own statements, produced as Annex R.10 to the application for interim measures. Those statements concern, in essence, the percentage which their sales on the EU market represent in relation to their total turnover and the fact that they would likely cease to exist within a very short period of time or would at least be seriously affected if they lost access to the EU market.

39      However, the applicants do not provide any evidence in support of their statements. They merely make vague assertions, without providing any numerical, accounting or other information capable of substantiating the existence of serious and irreparable damage.

40      Accordingly, the President of the General Court is not able to establish a true overall picture of the applicants’ financial situation, within the meaning of the case-law cited in paragraph 37 above.

41      In those circumstances, it must be held that the applicants have not succeeded in demonstrating that the condition of urgency was satisfied because of a risk to their financial viability.

42      In the third place, as regards the applicants’ argument that their action corroborates the seriousness of the damage, to the extent that they did not understand why the registration of SQS in the NANDO database had been altered, it must be held that, as the Commission demonstrated in paragraphs 16 and 17 of its observations, SQS and the applicants had been aware for several months that access to the EU market for their medical devices on the basis of certificates issued under Directive 93/42 was dependent on the favourable outcome of negotiations between the European Union and Switzerland on an update to the MRA. SQS and the applicants could therefore have foreseen the entry into application of Regulation 2017/745 on 26 May 2021.

43      In the fourth place, as regards the applicants’ argument that it would be impossible for them to recover the commercial opportunities they have lost or to make up the ground lost to their competitors which manufacture medical devices, it must be held that the applicants have not proved that the damage relied on in that regard is irreparable. The applicants confine themselves to mere assertions which are in no way substantiated by evidence. In addition, their assertions relate only to purely hypothetical damage, which can be assessed only when weighing up the various competing interests (see, to that effect, order of 17 February 2011, Comunidad Autónoma de Galicia v Commission, T‑520/10 R, not published, EU:T:2011:56, paragraph 77).

44      Moreover, the applicants have not demonstrated that, if the contested decision were annulled, the existence of obstacles of a structural or legal nature would prevent them from regaining their market shares (see, by analogy, order of 4 April 2006, Vischim v Commission, T‑420/05 R, not published, EU:T:2006:102, paragraph 76).

45      In the fifth and last place, as regards the applicants’ argument that their reputation in the EU market would remain damaged for years, it is clear that, in accordance with settled case-law, even if the applicants’ reputation were indeed damaged by the contested decision, the annulment of that decision at the conclusion of the main proceedings would constitute adequate compensation for the alleged non-pecuniary damage (see, by analogy, order of 6 April 2016, GABO:mi v Commission, T‑10/16 R, not published, EU:T:2016:197, paragraph 49 and the case-law cited).

46      It follows from all of the foregoing that the application for interim measures must be dismissed as the applicants have failed to prove that the condition relating to urgency is satisfied, without it being necessary to rule on whether there is a prima facie case or to weigh up the competing interests.

47      Under Article 158(5) of the Rules of Procedure, the costs are to be reserved.

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

1.      The application for interim measures is dismissed.

2.      The costs are reserved.

Luxembourg, 23 February 2022.