Order;Information — ECLI:EU:C:2024:320
Date: 2024-04-11
Language of the case: English
Court formation: Seventh Chamber
Subject matter: Public health
Procedure: Action for annulment;Appeal - unfounded

ORDER OF THE COURT (Seventh Chamber) 11 April 2024 (*) (Appeal – Article 181 of the Rules of Procedure of the Court of Justice – Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment – Regulation (EU) 2017/745 – Expiry of the designation of an entity as conformity assessment body for medical devices within the meaning of Directive 93/42/EEC – Removal of that entity from the list of notified bodies which have certificates validated under Directive 93/42/EEC – Action for annulment – Appeal manifestly unfounded) In Case C‑491/23 P, APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 2 August 2023, Atesos medical AG, established in Aarau (Switzerland), Bonebridge AG, established in Zug (Switzerland), Heico-Switzerland AG, established in Steinach (Switzerland), Keri Medical SA, established in Geneva (Switzerland), Medcem GmbH, established in Weinfelden (Switzerland), Stemcup Medical Products AG, established in Zürich (Switzerland), represented by S. De Knop and M. Meulenbelt, advocaten, appellants, the other parties to the proceedings being: MPS Precimed SA, established in Biel/Bienne (Switzerland), PX Dental SA, established in La Chaux-de-Fonds (Switzerland), applicants at first instance, European Commission, defendant at first instance, THE COURT (Seventh Chamber), composed of F. Biltgen, President of the Chamber, N. Wahl and M.L. Arastey Sahún (Rapporteur), Judges, Advocate General: A.M. Collins, Registrar: A. Calot Escobar, having decided, after hearing the Advocate General, to rule by reasoned order, pursuant to Article 181 of the Rules of Procedure of the Court of Justice, makes the following Order 1 By their appeal, Atesos medical AG, Bonebridge AG, Heico-Switzerland AG, Keri Medical SA, Medcem GmbH and Stemcup Medical Products AG ask the Court of Justice to set aside the order of the General Court of the European Union of 23 May 2023, Atesos medical and Others v Commission (T‑764/21, EU:T:2023:292; ‘the order under appeal’), by which the General Court dismissed as manifestly inadmissible their action for annulment of a decision of the European Commission stating that the designation of ‘Schweizerische Vereinigung für Qualitäts- und Management Systeme’ (‘SQS’) 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) had expired, and amending SQS’s entry in the database of notified and designated bodies, with effect from 28 September 2021 (‘the decision at issue’). Background to the dispute 2 The background to the dispute is set out in paragraphs 2 to 15 of the order under appeal and, for the purposes of the present proceedings, may be summarised as follows. 3 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’) was approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation (OJ 2002 L 114, p. 1). 4 Article 1(2) of the MRA provides, in essence, that, in order to avoid duplication of procedures when Swiss and European Union requirements are deemed equivalent, the European Union and the Swiss Confederation are mutually to accept reports, certificates and authorisations issued by their respective certification bodies. 5 SQS is a conformity assessment body for medical devices accredited and designated by the Swiss Government and recognised since 2003 as a notified body under EU law pursuant to Decision No 1/2003 of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement (OJ 2003 L 56, p. 1). 6 SQS was listed, on that basis, in the NANDO (New Approach Notified and Designated Organisations) information system established by the Commission, which lists all the recognised conformity assessment bodies. 7 The appellants are manufacturers of medical devices that were placed on the market in the European Union pursuant to Directive 93/42, after the conformity of each of those medical devices with quality and safety requirements was certified by SQS. 8 On 5 April 2017, the European Parliament and the Council of the European Union 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 (OJ 2017 L 117, p. 1). Regulation 2017/745 came into force on 26 May 2021 in accordance with Article 123(2) thereof as amended by 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). 9 On 26 May 2021, the Commission published a notice to stakeholders and a press release, informing them that the mutual recognition of medical devices between the European Union and the Swiss Confederation had ceased to apply from that date due to the applicability of Regulation 2017/745 and the fact that Chapter 4 of Annex 1 to the MRA had not been amended to include that new regulation, as the European Union and the Swiss Confederation had not reached an agreement in that regard. 10 In those documents, the Commission stated, inter alia, that existing certificates for medical devices issued under the MRA by conformity assessment bodies established in the Swiss Confederation would no longer be recognised as valid in the European Union as of 26 May 2021. 11 After that date and until 27 June 2021 at least, a pop-up window published by the Commission in the online database of the NANDO information system (‘the NANDO database’) on, inter alia, the page concerning SQS stated that that body was allowed to continue its surveillance activities only in respect of beneficiary legacy medical devices pursuant to Article 120 of Regulation 2017/745. 12 On 28 September 2021, the Commission amended the entry for SQS in the NANDO database. 13 By letter of 25 October 2021, SQS asked the Commission, in essence, to reinstate its listing in the NANDO database as a conformity assessment body with a designation under Directive 93/42. 14 On 22 November 2021, the Commission replied, in essence, that the amendment of the entry corresponding to SQS in the NANDO database made on 28 September 2021, reflected the legal position of that body following the cessation of the application of the MRA in relation to medical devices as from 26 May 2021. The proceedings before the General Court and the order under appeal 15 By application lodged at the Registry of the General Court on 8 December 2021, the appellants brought an action for annulment of the decision at issue. 16 By the order under appeal, the General Court held that that action did not concern a measure which can be the subject of an action for annulment under Article 263 TFEU and, consequently, dismissed that action as manifestly inadmissible. Forms of order sought by the appellants 17 By their appeal, the appellants ask the Court of Justice to set aside the order under appeal, uphold the action at first instance, annul the decision at issue and order the Commission to pay the appellants’ costs and bear its own costs, both at first instance and on appeal. 18 In the alternative, the appellants ask the Court of Justice to set aside the order under appeal, to refer the case back to the General Court and to reserve the costs incurred at first instance and on appeal pending the final judgment of the General Court. The appeal 19 Under Article 181 of the Rules of Procedure of the Court of Justice, where the appeal is, in whole or in part, manifestly inadmissible or manifestly unfounded, the Court may at any time, acting on a proposal from the Judge-Rapporteur and after hearing the Advocate General, decide by reasoned order to dismiss the appeal in whole or in part. 20 It is appropriate to apply that provision in the present case. 21 In support of their appeal, the appellants put forward five grounds of appeal, alleging errors of law, distortion of the facts and a failure by the General Court to meet its obligation to state reasons. The first ground of appeal Arguments of the appellants 22 By the first ground of appeal, the appellants submit that the General Court erred in law, first, by finding that the designation of SQS had expired as a consequence of the entry into force of Regulation 2017/745 and of the failure to update the MRA and, second, by failing to examine the continued protection of SQS’s designation under the MRA. 23 They allege that the General Court conflated the question of the continued validity of the designation of SQS as a notified body with that of the continued validity of the certificates issued by SQS under Directive 93/42. 24 They claim that that court failed to explain on what grounds SQS’s designation was affected by the entry into force, on 26 May 2021, of Regulation 2017/745. In that regard, the only procedure whereby the benefits of mutual recognition of a designated conformity assessment body can be rescinded is set out in Article 8 of the MRA. That provision allows a party to contest the competence of a designated conformity assessment body through a procedure steered by the committee provided for under Article 10(1) of the MRA. However, the Commission never contested the technical competence of SQS and the validity of its designation was thus never called into question by following the procedural channels under the MRA. 25 The General Court allegedly failed to take into account the protective effect of the MRA as regards the designation and recognition of SQS in the European Union and did not explain how that designation could have expired ipso jure. 26 They argue that, in addition, in paragraph 53 of the order under appeal, the General Court did not explain on what grounds an update of the MRA would have been necessary to protect the mutual recognition of the designation of SQS under Article 5 of Regulation 2017/745. 27 They claim that, although the transitional provisions of that regulation and, more specifically, Article 120(3) and (4) thereof govern the issue of the continued putting on the market of medical devices for which certificates were issued before 26 May 2021, those provisions do not concern the issue of the continued validity of the designations of notified bodies made under Directive 93/42 before that date. 28 It is their submission that, in those circumstances, it is not possible to argue that that absence of rules as regards the transitional aspects of the validity of those designations had the effect of causing them to expire immediately. 29 The appellants add that, by finding, in paragraph 53 of the order under appeal, that the designation or recognition of SQS had expired with the entry into force of Regulation 2017/745, the General Court infringed Article 5 of the MRA. Findings of the Court 30 In the first place, the Court of Justice notes that, in paragraph 39 of the order under appeal, the General Court found that, by Decision No 1/2003 of the Committee provided for in Article 10(1) of the MRA, SQS was included in the list of conformity assessment bodies recognised in the context of that agreement. 31 In the second place, in paragraphs 40 and 41 of the order under appeal, the General Court held that Articles 35 to 50 of Regulation 2017/745 are applicable to the appellants’ situation. 32 In the third place, in paragraphs 42 to 46 of the order under appeal, the General Court examined the provisions of Regulation 2017/745 and concluded that the Commission does not have any discretion when publishing the notification of a conformity assessment body designated by a Member State in the NANDO database. 33 In the fourth place, in paragraphs 49 to 51 of the order under appeal, the General Court held that the validity of the designation of the bodies in question does not depend on whether they are listed in the NANDO database, but on whether they are designated by the Member States, the European Union or the Swiss Confederation. 34 The General Court added, in paragraph 52 of that order, that the Commission does not have competence to designate the bodies in question or to issue decisions regarding the expiry of their designation. 35 In the fifth place, the General Court found, in paragraph 53 of the order under appeal, that the expiry and invalidity of the designation of SQS and the certificates issued by that authority pursuant to Directive 93/42 are the consequence of the entry into force of Regulation 2017/745 and the subsequent repeal of that directive by Article 122 of that regulation, and of the fact that Chapter 4 of Annex 1 to the MRA was not amended to include the new regulation in its entirety. 36 In the sixth place, the General Court held, in paragraph 54 of the order under appeal, that the expiry and invalidity of the designation of SQS and the certificates issued by that authority pursuant to Directive 93/42 do not, therefore, result from the decision at issue, which did not produce any legal effect distinct from the effects produced by the entry into force of Regulation 2017/745. 37 That being so, in the context of the first ground of appeal, the appellants have failed to show how the General Court’s interpretation of the provisions of the MRA and of the provisions of Regulation 2017/745 is vitiated by an error of law. 38 In particular, the appellants’ assertion that the only procedure whereby the benefits of mutual recognition of a designated conformity assessment body can be rescinded is set out in Article 8 of the MRA is manifestly unfounded. 39 That provision, headed ‘Verification of compliance of conformity assessment bodies’, provides for the right of each party to the MRA, in exceptional circumstances, to contest the technical competence of the conformity assessment bodies either proposed by the other party or recognised and listed as being under the jurisdiction of the other party. 40 In that regard, it is sufficient to note that that option of contesting that technical competence, as laid down in Article 8 of the MRA, is without prejudice to the fact – correctly found by the General Court – that, first, conformity assessment bodies are designated by being notified by Member States, in accordance with the provisions of Regulation 2017/745, and, second, the expiry and invalidity of the designation of SQS and of the certificates issued by that body are the consequence of Chapter 4 of Annex 1 to the MRA not being amended to include the whole of that regulation following its entry into force. 41 As regards the appellants’ argument relating to the transitional provisions of Regulation 2017/745 and, more specifically, Article 120(3) and (4) thereof, which govern the question of the continued placing on the market of medical devices, it is sufficient to note that those provisions were not the basis of the General Court’s reasoning in the order under appeal and, consequently, are irrelevant to the General Court’s finding in paragraph 53 of that order. 42 The appellants also submit that that finding failed to take account of Article 5 of the MRA. 43 In that regard, the Court notes that, under that article, the parties are to recognise that conformity assessment bodies recognised in accordance with the procedure laid down in Article 11 of that agreement fulfil the conditions of eligibility to assess conformity. 44 In their appeal, the appellants do not explain how the General Court’s reasoning, according to which the expiry and invalidity of the designation of SQS are the consequence of the entry into force of Regulation 2017/745 and of the failure to amend Chapter 4 of Annex 1 to the MRA to include the whole of that new regulation, fails to take into account Article 5 of the MRA. 45 In the light of the findings above, the first ground of appeal must be rejected as manifestly unfounded. The second ground of appeal Arguments of the appellants 46 By the second ground of appeal, which is divided, in essence, into two parts, the appellants claim that the General Court erred in law, first, by finding that the decision at issue had not produced effects capable of bringing about a distinct change to their legal situation and, second, by failing to recognise that the Commission engaged in the falsification of records and official declarations from a third country. 47 In the first part of that ground, the appellants submit that, both under Regulation 2017/745 – more specifically, Article 42(11) thereof –and under the MRA, the publication of a designation of a conformity assessment body in the NANDO information system is of fundamental importance, since the designation is not valid before it is published. 48 Moreover, the General Court allegedly confirmed that interpretation in paragraph 45 of the order under appeal. 49 They maintain that, when the Commission removed SQS from the NANDO database, it stated that it no longer recognised the validity of that body’s designation, despite the existence of a certificate of designation which remained valid. That, they claim, undermines the effet utile of that designation. If SQS continues to exert its functions as a notified body, it could be subject to penalties imposed by national authorities under Article 113 of Regulation 2017/745. At the same time, if SQS suspends its post-market surveillance functions, it could be subject to legal proceedings by manufacturers or end users seeking damages on the basis of contractual or non-contractual liability for failure to meet its duty to be alert, as follows from the judgment of 16 February 2017, Schmitt (C‑219/15, EU:C:2017:128, paragraph 60). In those circumstances, the removal of SQS from the NANDO database did produce legal effects. 50 It is their submission that, consequently, the General Court erred in law in finding, in paragraph 54 of the order under appeal, that the decision at issue had not produced legal effects. 51 The appellants add that the General Court did not examine any of their arguments raised in order to demonstrate that the decision at issue did produce legal effects and did not compare those effects with those of the entry into force of Regulation 2017/745. 52 Contrary to what the General Court found in paragraph 55 of the order under appeal, the situation in the present case is, they allege, not comparable to the situation which gave rise to the judgment of 13 February 2014, Hungary v Commission (C‑31/13 P, EU:C:2014:70). 53 They argue that, in paragraph 56 of that judgment, the General Court held that the automatic protection granted to designations of origin under EU law is a mere extension of the protection of wine names as recognised by national legislation. 54 However, they claim that, in the present case, the legal effects of the decision at issue should be assessed in relation to the interaction between secondary EU law and the MRA. 55 They submit that, since only the Court of Justice has jurisdiction to give binding interpretations of EU law, it is not for the General Court to address the question of maintaining the validity of SQS’s designation. 56 In the appellants’ view, it is necessary to take as a basis, by analogy, the judgment of 9 October 1990, France v Commission (C‑366/88, EU:C:1990:348, paragraph 11), and to examine the content of the decision at issue in order to ascertain whether it produced legal effects. 57 In the second part of the second ground of appeal, the appellants submit that the Commission falsified the date of expiry of SQS’s designation by setting it at 28 September 2021, with no foundation in law, whereas the validity of SQS’s status as a notified body was extended until 29 July 2022 as a result of the issuance, on 30 January 2018, of a designation certificate by the Swiss designating authority Swissmedic. 58 They maintain that the General Court should have declared the appellants’ action admissible in order to enable them to challenge the decision at issue, in accordance with Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’). Findings of the Court 59 As regards the first part of the second ground of appeal, it should be borne in mind that, as the appellants observe, the General Court found, in paragraph 45 of the order under appeal, that, under Article 42(11) of Regulation 2017/745, the designation of a conformity assessment body is to become valid the day after the notification is published in the NANDO database, whereas the published notification is to state the scope of lawful conformity assessment activity of the notified body. 60 However, after examining, in paragraphs 42 and 43 of the order under appeal, the scope of Article 42(2) and (6) of that regulation, the General Court concluded, in paragraph 46 of that order, that, as follows from Article 42(2), (6), (8), (9) and (11), the Commission does not have any discretion when publishing the notification of a conformity assessment body designated by a Member State in the NANDO database. 61 The appellants’ argument, which is based solely on the wording of Article 42(11) of Regulation 2017/745, is clearly not capable of calling into question the interpretation of that regulation adopted by the General Court in the order under appeal, which relates, as is apparent from paragraph 53 of the order under appeal, to a particular case, namely the consequences, first, of the entry into force of Regulation 2017/745 and, second, of the failure to amend Chapter 4 of Annex 1 to the MRA. 62 As regards the reference to the judgment of 13 February 2014, Hungary v Commission (C‑31/13 P, EU:C:2014:70), in paragraph 55 of the order under appeal, it is sufficient to note that that reference was made in the context of the conclusion, set out in the same paragraph, reached on the basis of a series of grounds developed by the General Court in paragraphs 31 to 54 of that order. 63 That conclusion, according to which the decision at issue does not produce legal effects vis-à-vis the appellants, itself refers to the criteria set out in that regard in the case-law of the Court of Justice cited in paragraph 31 of the order under appeal, namely the judgment of 26 January 2010, Internationaler Hilfsfonds v Commission (C‑362/08 P, EU:C:2010:40, paragraph 51 and the case-law cited), criteria which the appellants do not call into question in the context of the second ground of appeal. 64 As regards the second part of the second ground of appeal and the appellants’ argument that the General Court should have found their action admissible in order to allow them to challenge the decision at issue and to rely on a falsification of records, it is sufficient to conclude that that argument is based on reasoning that is circular in nature. In order to find that an action is admissible, it is necessary, first of all, to examine whether the measure which is the subject of that action produces binding legal effects on the person concerned (see, to that effect, judgments of 26 January 2010, Internationaler Hilfsfonds v Commission, C‑362/08 P, EU:C:2010:40, paragraph 55 and the case-law cited, and of 14 October 2021, KF v SatCen, C‑464/20 P, EU:C:2021:848, paragraph 26 and the case-law cited). 65 Since the General Court did so in the order under appeal and having regard to paragraphs 59 to 63 of the present order, the General Court did not err in law in that regard. In those circumstances, the second ground of appeal must be rejected as manifestly unfounded. The third ground of appeal Arguments of the appellants 66 By the third ground of appeal, the appellants submit that the General Court erred in law in so far as, after finding that the Commission lacked competence to issue the decision at issue, it declared the action inadmissible, whereas it should instead have annulled that decision on grounds of lack of competence. In addition, the decision at issue fails to state the reasons on which it is based. 67 They argue that, in paragraph 52 of the order under appeal, the General Court held that the Commission does not have competence to declare that the designation of SQS had expired and that, consequently, the decision at issue had not produced legal effects. 68 It is their submission that, in paragraph 54 of that order, the General Court held that, in those circumstances, the expiry and invalidity of the designation of SQS and of the certificates issued by that authority did not result from the decision at issue. 69 In the appellants’ view, that reasoning of the General Court is flawed and circular. 70 They claim that the Commission was obliged to ensure that the NANDO database correctly reflects the list of valid designation certificates notified to it by the Swiss Confederation. However, the Commission decided to call into question the effet utile of SQS’s designation certificate which was still valid, and thereby went beyond the scope of its mandate in that respect. 71 They maintain that the fact that the Commission went beyond the scope of its mandate should have been taken into consideration by the General Court and should have led to the annulment of the decision at issue. Findings of the Court 72 Contrary to what the appellants claim, the fact, noted in paragraph 52 of the order under appeal, that the Commission does not have competence to designate the bodies in question or to issue decisions regarding the expiry of their designation cannot automatically mean that an amendment made by that institution in the NANDO database must be subject to judicial review by the General Court. 73 As the General Court correctly held in the order under appeal, that review concerns only measures which produce binding legal effects with regard to the person concerned. 74 Furthermore, contrary to what the appellants claim in the third ground of appeal, the order under appeal is not vitiated by a failure to state reasons, since the General Court sufficiently set out the grounds for its reasoning, as is apparent from the examination of the first ground of appeal. 75 Accordingly, the third ground must be rejected as being manifestly unfounded. The fourth ground of appeal Arguments of the appellants 76 By the fourth ground of appeal, the appellants complain that the General Court distorted the facts by incorrectly asserting that the action for annulment was directed against a Commission notice of 26 May 2021, whereas, in reality, it was directed against the Commission’s decision of 28 September 2021, by which the Commission amended the entry for SQS in the NANDO database. 77 In that regard, the appellants state that, in paragraphs 85 and 88 of their application before the General Court, they clearly distinguished the Commission’s decision of 28 September 2021 from the Commission’s notice of 26 May 2021. 78 However, it is their submission that, in paragraph 56 of the order under appeal, the General Court held that the Commission’s notice of 26 May 2021 was not binding. 79 The appellants argue that a notice to stakeholders is a press release which, as the General Court held, is not binding and does not produce legal effects. 80 They claim that, by incorrectly holding that, in their application, the appellants sought the annulment of the Commission’s notice of 26 May 2021, the General Court made an error that adversely affected the reasoning in the order under appeal. 81 In so doing, the General Court allegedly failed to observe the appellants’ rights to good administration and to an effective remedy within the meaning of Article 41(2) and Article 47 of the Charter. Findings of the Court 82 The Court of Justice notes that, in paragraph 1.1 of the application at first instance, the appellants asked the General Court to annul ‘the unpublished decision of an unknown date of the European Commission … that (1) falsely asserts the expiry, as of 28 September 2021, of the designation of [SQS] as a conformity assessment body for medical devices under [Directive 93/42]; and (2) “delists” SQS from [the NANDO database] as of 28 September 2021’. 83 Therefore, in finding, in paragraph 1 of the order under appeal, that the action brought before it was directed against the Commission’s decision stating that the designation of SQS as a conformity assessment body had expired and amending its entry in the database of notified and designated bodies, with effect from 28 September 2021, the General Court did not distort the facts. 84 That conclusion is, moreover, supported by the reasoning adopted by the General Court in the order under appeal. 85 In paragraphs 42 to 51 of that order, the General Court examined the scope of the listing made by the Commission in the NANDO database and concluded that the validity of the designation of the bodies in question did not depend on whether they were listed. 86 It follows from the above that the General Court examined the scope of the amendment made by the Commission on 28 September 2021 to SQS’s entry in the NANDO database. 87 It is true, as the appellants submit in the fourth ground of appeal, that the General Court referred, in paragraph 56 of the order under appeal, to the Commission’s notice of 26 May 2021. 88 However, as is apparent from the use of the word ‘moreover’, the finding in that paragraph to the effect that the notice and press release issued by the Commission on 26 May 2021 do not result in an act within the meaning of the case-law referred to in paragraph 31 of the order under appeal was provided for the sake of completeness. Such a finding is not capable of calling into question the fact that it was the decision at issue which was examined by the General Court, as is apparent from paragraphs 82 to 86 of the present order. 89 In those circumstances, the fourth ground of appeal must be rejected as manifestly unfounded. The fifth ground of appeal Arguments of the appellants 90 By the fifth ground of appeal, the appellants submit that the General Court erred in law and failed to meet its obligation to state reasons ‘by declaring the action inadmissible on the grounds that the … substantive arguments “must be rejected”, whilst failing to engage with those substantive arguments’. 91 The appellants submit that, in the order under appeal, the question of the examination of the substance of the case overlaps with the examination of the admissibility of the application at first instance. The General Court therefore erred, in paragraph 57 of the order under appeal, when it rejected summarily and without explanation the arguments put forward by the appellants. 92 It is their submission that, consequently, by holding that the application was manifestly inadmissible, the General Court infringed Article 126 of its Rules of Procedure and deprived the appellants of their right to judicial review, contrary to Article 47 of the Charter. Findings of the Court 93 Contrary to what the appellants claim, the General Court did not err in law and did not fail to meet its obligation to state reasons ‘by declaring the action inadmissible on the grounds that the … substantive arguments “must be rejected”, whilst failing to engage with those substantive arguments’. 94 As is apparent from the examination of the other grounds of appeal, the General Court assessed the legal nature of the decision at issue and gave sufficient reasons in support of its conclusion that that decision had no binding effects. 95 The fifth ground of appeal must therefore be rejected as manifestly unfounded. 96 In the light of the reasons set out above, the appeal must be dismissed in its entirety as manifestly unfounded. Costs 97 Under Article 137 of the Rules of Procedure of the Court of Justice, applicable to proceedings on appeal pursuant to Article 184(1) of those rules, a decision as to costs is to be given in the order which closes the proceedings. In this instance, since the present order has been adopted before the appeal was served on the other parties to the proceedings and, therefore, before they could have incurred costs, it is appropriate to decide that the appellants are to bear their own costs. On those grounds, the Court (Seventh Chamber) hereby orders: 1. The appeal is dismissed as manifestly unfounded. 2. Atesos medical AG, Bonebridge AG, Heico-Switzerland AG, Keri Medical SA, Medcem GmbH and Stemcup Medical Products AG shall bear their own costs. Luxembourg, 11 April 2024. A. Calot Escobar F. Biltgen Registrar President of the Chamber * Language of the case: English.