23 May 2023 (*)

(Action for annulment – Medical devices – Directive 93/42/EEC – Expiry of the validity of certificates for medical devices issued under the mutual recognition agreement by bodies established in Switzerland – Amendment of the entry in the online database of the NANDO information system corresponding to the conformity assessment body for medical devices which had issued the certificates – Act not open to challenge – Manifest inadmissibility)

In Case T‑764/21,

Atesos medical AG,

established in Aarau (Switzerland), and the other applicants whose names are listed in the annex, (1) represented by M. Meulenbelt and S. De Knop, lawyers,

applicants,

European Commission,

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

defendant,

THE GENERAL COURT (Sixth Chamber),

composed of M.J. Costeira, President, M. Kancheva and P. Zilgalvis (Rapporteur), Judges,

Registrar: T. Henze, Acting Registrar,

having regard to the written part of the procedure,

having regard to the order of 23 February 2022, Atesos medical and Others v Commission, T‑764/21 R, not published, by which the President of the General Court rejected the applicants’ request to suspend the operation of the contested decision,

makes the following

By their action under Article 263 TFEU, the applicant, Atesos medical AG, and the other applicants whose names are listed in the annex, seek annulment of a European Commission decision 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 contested decision’).

Background to the dispute

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).

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.

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).

SQS was listed, on that basis, in the Commission’s NANDO (New Approach Notified and Designated Organisations) information system, which lists all the recognised conformity assessment bodies.

The applicants 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 these medical devices with quality and safety requirements was certified by SQS.

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 (OJ 2017 L 117, p. 1). According to recital 1 of Regulation 2017/745, that regulation is intended to carry out a fundamental revision of those directives in order to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.

Regulation 2017/745 entered 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).

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 entry into force 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.

In the documents in question, the Commission stated, inter alia, that existing certificates for medical devices issued under the MRA by conformity assessment bodies established in Switzerland would no longer be recognised as valid in the European Union as of 26 May 2021.

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 the notified body was allowed to continue its surveillance activities only in respect of beneficiary legacy medical devices pursuant to Article 120 of Regulation 2017/745.

By email of 20 September 2021, the Agence nationale de sécurité du médicament et des produits de santé (National Agency for the Safety of Medicinal Products and Health Products, France) indicated to the Commission that there was an inconsistency between the notice to stakeholders and the fact that SQS was still registered in the NANDO database as being allowed to carry out market surveillance activities.

On 28 September 2021, the Commission amended the entry for SQS in the NANDO database.

On 25 October 2021, SQS sent a letter to the Commission asking it, in essence, to reinstate its listing in the NANDO database as a conformity assessment body with a designation under Directive 93/42.

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.

Forms of order sought

The applicants claim that the Court should:

–annul the contested decision;

–order the Commission to pay the costs.

The Commission contends that the Court should:

–dismiss the action as manifestly inadmissible and, in the alternative, as unfounded;

–order the applicants to pay the costs.

Law

Under Article 126 of the Rules of Procedure of the General Court, where the action is manifestly inadmissible or manifestly lacking any foundation in law, the General Court may, on a proposal from the Judge-Rapporteur, at any time decide to give a decision by reasoned order without taking further steps in the proceedings.

In the present case, the Court considers that it has sufficient information from the documents before it and decides, pursuant to that article, to give its decision without taking further steps in the proceedings.

Without formally raising an objection of inadmissibility under Article 130 of the Rules of Procedure, the Commission submits that the action is manifestly inadmissible.

In the first place, according to the Commission, the contested decision is not a reviewable act for the purposes of Article 263 TFEU.

First of all, the Commission submits that the applicants have not established the existence of the contested decision and that they seek annulment of an act that does not exist since it did not issue a decision providing for the expiry of the designation of SQS as a conformity assessment body for medical devices under Directive 93/42 and amending its entry in the NANDO database.

Moreover, according to the Commission, since the applicants do not identify the contested decision properly in the application, they do not satisfy the admissibility requirements provided for in Article 76(d) of the Rules of Procedure.

Next, the Commission is of the view that the operational change made to the NANDO information system by its services to reflect the legal position of SQS following the entry into force of Regulation 2017/745 does not produce any legal effect and does not bring about a change in the applicants’ legal position.

Lastly, the Commission adds that the continued validity within the European Union of the certificates issued by SQS does not depend on the listing of SQS in the NANDO database, but flows from the application of the MRA and of Regulation 2017/745, with the result that the position of the applicants was not affected by the change made in the NANDO database.

In the second place, the Commission submits that, even if the contested decision were considered to be a reviewable act, it is not of direct concern to the applicants.

According to the applicants, in the first place, the contested decision is a binding act which has produced legal effects as from 28 September 2021 within the European Union. They argue that the change made to SQS’s entry in the NANDO database is the result of that decision, the effect of which was to amend the designation of SQS under Directive 93/42 and to ‘delist’ it from that database. They add, in essence, that that decision cannot be the notice to stakeholders.

In the second place, the applicants claim, in essence, that the contested decision is of direct and individual concern to them and, in the alternative, that it is a regulatory act which is of direct concern to them and does not entail implementing measures.

In the third place, the applicants assert that they have an interest in bringing proceedings.

In the fourth place, the applicants submit that the contested decision may not, and must not, produce any legal effects, inter alia because the designation of SQS made in 2018 under Directive 93/42, as updated on 2 February 2018 and accepted by the Commission on 11 February 2018, cannot be undone as the MRA remains in full force and that decision did not suspend, alter, or terminate that agreement.

It must be borne in mind that, according to settled case-law, only measures the legal effects of which are binding on, and capable of affecting the interests of, the applicant by bringing about a distinct change in the applicant’s legal position may be the subject of an action for annulment under Article 263 TFEU (see, to that effect, judgment of 26 January 2010, Internationaler Hilfsfonds v Commission, C‑362/08 P, EU:C:2010:40, paragraph 51 and the case-law cited).

In addition, the binding legal effects of a measure must be assessed in accordance with objective criteria, such as the contents of that measure, taking into account, as appropriate, the context in which it was adopted and the powers of the institution which adopted the measure (see judgment of 13 February 2014, Hungary v Commission, C‑31/13 P, EU:C:2014:70, paragraph 55 and the case-law cited).

In the present case, the applicants seek annulment of a Commission decision stating that the designation of SQS as a conformity assessment body for medical devices under Directive 93/42 had expired and amending its entry in the NANDO database.

In the first place, it must be borne in mind that under Article 1(1) thereof, Regulation 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the European Union.

According to Article 35(1) of Regulation 2017/745, any Member State that intends to designate a conformity assessment body as a notified body, or has designated a notified body, to carry out conformity assessment activities under that regulation is to appoint an authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for the monitoring of notified bodies, including subcontractors and subsidiaries of those bodies.

It follows that the Member States have competence to designate conformity assessment bodies for the purposes of applying Regulation 2017/745.

In the second place, regarding the MRA, Article 10(1) thereof establishes a ‘Committee’, composed of representatives of the parties to that agreement, which is responsible for the management and monitoring of the smooth functioning of the agreement (‘the Committee’).

Moreover, Section II, entitled ‘Conformity assessment bodies’, of Chapter 4 of Annex 1 to the MRA, regarding medical devices, provides, in essence, that the Committee is to draw up and keep up to date a list of the conformity assessment bodies on the basis of the designation of those bodies by the European Union or the Swiss Confederation.

It follows that the Committee has competence to draw up the list of the conformity assessment bodies recognised in the MRA on the basis of the designation of those bodies by the European Union or the Swiss Confederation. Moreover, Decision 1/2003 of the Committee of 28 January 2003 included SQS in the list of conformity assessment bodies recognised in the context of that agreement (see paragraph 4 above).

In the third place, it must be borne in mind that, first, Chapter 4 of Annex 1 to the MRA, entitled ‘Medical devices’, contains, in Section I, the list of legislative, regulatory and administrative provisions covered by Article 1(2) of the agreement, which includes, inter alia, Directive 93/42 and Chapter IV of, and Annex VII to, Regulation 2017/745.

Articles 35 to 50 of Regulation 2017/745 relating to notified bodies are therefore applicable to the applicants’ situation.

Second, it should be noted that Article 42(2) of Regulation 2017/745 provides that ‘Member States shall notify the Commission and the other Member States of the conformity assessment bodies they have designated, using the electronic notification tool within the database of notified bodies developed and managed by the Commission (NANDO)’.

Under Article 42(6) of Regulation 2017/745, following a notification, the Commission is required, where no objection is raised, to publish the Member States’ notifications in the NANDO database within 42 days.

In the event that an objection is raised, it is apparent, in essence, from Article 42(9) of Regulation 2017/745, that where a Member State decides, after responding to that objection in accordance with the conditions laid down in Article 42(8) of that regulation, to uphold its decision to designate a conformity assessment body, the Commission is required to publish the notification of that body in the NANDO database within 14 days.

Subsequently, under Article 42(11) of Regulation 2017/745, the designation is to become valid the day after the notification is published in the NANDO database and the published notification is to state the scope of lawful conformity assessment activity of the notified body.

It follows from Article 42(2), (6), (8), (9) and (11) of Regulation 2017/745 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.

Article 43(2) of Regulation 2017/745 provides as follows:

‘The Commission shall make the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the conformity assessment activities as defined in this Regulation and the types of devices for which they have been notified, accessible to the public in NANDO. It shall also make this list available on the electronic system referred to in Article 57. The Commission shall ensure that the list is kept up to date.’

In that connection, paragraph 1 of Article 57 of Regulation 2017/745, which is entitled ‘Electronic system on notified bodies and on certificates of conformity’, provides that the Commission is to set up and manage an electronic system to collate and process information such as, inter alia, the list of notified bodies referred to in Article 43(2) of that regulation.

Therefore, the sole purpose of a listing in the NANDO database is to collate, process and make available information relating to the notified bodies.

The listing in the NANDO database therefore has no effect on the validity of the designation of notified bodies under Regulation 2017/745 or Directive 93/42 or on the expiry date of the validity of the designation of those bodies by the Member States or, in the framework of the MRA, by the Committee.

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.

Moreover, the Commission does not have competence to designate the bodies in question or to issue decisions regarding the expiry of their designation.

In those circumstances, 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.

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 contested decision, which did not produce any legal effect distinct from the effects produced by the entry into force of Regulation 2017/745.

Consequently, as the Commission argues, the contested decision does not produce legal effects which are capable of bringing about a distinct change in the applicants’ legal position within the meaning of the case-law referred to in paragraph 31 above (see, to that effect and by analogy, judgment of 13 February 2014, Hungary v Commission, C‑31/13 P, EU:C:2014:70, paragraphs 56 to 65).

Moreover, 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 above. In those documents, the Commission merely set out its understanding of the interaction between the MRA and Regulation 2017/745 and of the legal consequences of the entry into force of that regulation on the application of that agreement (see paragraph 9 above).

In those circumstances, the applicants’ arguments relating to the interpretation of the MRA or the interpretation of the substantive provisions of Regulation 2017/745 must be rejected. Those arguments do not call into question the fact that the present action is not directed against a measure which can be the subject of an action for annulment under Article 263 TFEU.

Having regard to the foregoing, the action is manifestly inadmissible.

Costs

Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

Since the applicants have been unsuccessful, they must be ordered to pay the costs, including the costs relating to the proceedings for interim relief, in accordance with the form of order sought by Commission.

On those grounds,

hereby orders:

1.The action is dismissed as manifestly inadmissible.

2.Atesos medical AG, Bonebridge AG, Heico-Switzerland AG, Keri Medical SA, Medcem GmbH, MPS Precimed SA, PX Dental SA and Stemcup Medical Products AG shall bear their own costs and pay those incurred by the European Commission, including those relating to the proceedings for interim relief.

Luxembourg, 23 May 2023.

Acting Registrar

President

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Language of the case: English.

The list of the other applicants is annexed only to the version sent to the parties.