# 62017CJ0346

JUDGMENT OF THE COURT (Third Chamber)

6 September 2018 (
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(Appeal — Second paragraph of Article 340 TFEU — Non-contractual liability of the European Union — Directive 93/42/EEC — Medical devices — Article 8(1) and (2) — Safeguard clause procedure — Notification by a Member State of a decision prohibiting the placing on the market of a medical device — Absence of a decision by the European Commission — Sufficiently serious breach of a rule of law intended to confer rights on individuals — Causal link between the conduct of the institution and the damage alleged — Evidence of the existence and extent of the damage)

In Case C‐346/17 P,

APPEAL under Article 56 of the Statute of the Court of Justice of the European Union, brought on 9 June 2017,

Christoph Klein, residing in Groβgmain (Austria), represented by H.-J. Ahlt, Rechtsanwalt,

Christoph Klein

appellant,

the other parties to the proceedings being:

European Commission, represented by G. von Rintelen, A. Sipos and A.C. Becker, acting as Agents,

European Commission

defendant at first instance,

Federal Republic of Germany,

Federal Republic of Germany,

intervener at first instance,

THE COURT (Third Chamber),

composed of L. Bay Larsen, President of the Chamber, J. Malenovský, M. Safjan (Rapporteur), D. Šváby and M. Vilaras, Judges,

Advocate General: M.Y. Bot,

Registrar: M. Aleksejev, Administrator,

having regard to the written procedure and further to the hearing on 8 February 2018,

after hearing the Opinion of the Advocate General at the sitting on 21 March 2018,

gives the following

Judgment

Judgment

| 1 | By his appeal, Mr Christoph Klein requests the Court of Justice to set aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‐309/10 RENV, not published, EU:T:2016:570; ‘the judgment under appeal’), by which that Court dismissed his action seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1). |
| --- | --- |

1

By his appeal, Mr Christoph Klein requests the Court of Justice to set aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‐309/10 RENV, not published, EU:T:2016:570; ‘the judgment under appeal’), by which that Court dismissed his action seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ 1993 L 169, p. 1).

Legal context

Legal context

| 2 | Paragraphs 1 and 2 of Article 1 of Directive 93/42, entitled ‘Definitions, scope’, provide:
  ‘1.   This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
  2.   For the purposes of this Directive, the following definitions shall apply:





  (a) | “medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:





  – | diagnosis, prevention, monitoring, treatment or alleviation of disease, |
| --- | --- | --- | --- |

2

Paragraphs 1 and 2 of Article 1 of Directive 93/42, entitled ‘Definitions, scope’, provide:

‘1.   This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.

2.   For the purposes of this Directive, the following definitions shall apply:

(a)

“medical device” means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

–

diagnosis, prevention, monitoring, treatment or alleviation of disease,

| – | diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, |
| --- | --- |

–

diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

| – | investigation, replacement or modification of the anatomy or of a physiological process, |
| --- | --- |

–

investigation, replacement or modification of the anatomy or of a physiological process,

| – | control of conception, |
| --- | --- |

–

control of conception,

and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

...

| (f) | “manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
  The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient; |
| --- | --- |

(f)

“manufacturer” means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;

...’

| 3 | Article 2 of that directive, entitled ‘Placing on the market and putting into service’, provides:
  ‘Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.’ |
| --- | --- |

3

Article 2 of that directive, entitled ‘Placing on the market and putting into service’, provides:

‘Member States shall take all necessary steps to ensure that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients, users and, where applicable, other persons when properly installed, maintained and used in accordance with their intended purpose.’

| 4 | Article 3 of that directive, entitled ‘Essential requirements’, is worded as follows:
  ‘The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.’ |
| --- | --- |

4

Article 3 of that directive, entitled ‘Essential requirements’, is worded as follows:

‘The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.’

| 5 | Article 8 of Directive 93/42, entitled ‘Safeguard clause’, states:
  ‘1.   Where a Member State ascertains that the devices referred to in Article 4(1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:





  (a) | failure to meet the essential requirements referred to in Article 3; |
| --- | --- | --- |

5

Article 8 of Directive 93/42, entitled ‘Safeguard clause’, states:

‘1.   Where a Member State ascertains that the devices referred to in Article 4(1) and (2) second indent, when correctly installed, maintained and used for their intended purpose, may compromise the health and/or safety of patients, users or, where applicable, other persons, it shall take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such measures, indicating the reasons for its decision and, in particular, whether non-compliance with this Directive is due to:

(a)

failure to meet the essential requirements referred to in Article 3;

| (b) | incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied; |
| --- | --- |

(b)

incorrect application of the standards referred to in Article 5, in so far as it is claimed that the standards have been applied;

| (c) | shortcomings in the standards themselves. |
| --- | --- |

(c)

shortcomings in the standards themselves.

2.   The Commission shall enter into consultation with the parties concerned as soon as possible. Where, after such consultation, the Commission finds that:

| – | the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6, |
| --- | --- |

–

the measures are justified, it shall immediately so inform the Member State which took the initiative and the other Member States; where the decision referred to in paragraph 1 is attributed to shortcomings in the standards, the Commission shall, after consulting the parties concerned, bring the matter before the Committee referred to in Article 6(1) within two months if the Member State which has taken the decision intends to maintain it and shall initiate the procedures referred to in Article 6,

| – | the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the [European Union]. |
| --- | --- |

–

the measures are unjustified, it shall immediately so inform the Member State which took the initiative and the manufacturer or his authorised representative established within the [European Union].

3.   Where a non-complying device bears the CE marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof.

4.   The Commission shall ensure that the Member States are kept informed of the progress and outcome of this procedure.’

| 6 | Article 18 of Directive 93/42, entitled ‘Wrongly affixed CE marking’, provides:
  ‘Without prejudice to Article 8:





  (a) | where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the [European Union] shall be obliged to end the infringement under conditions imposed by the Member State; |
| --- | --- | --- |

6

Article 18 of Directive 93/42, entitled ‘Wrongly affixed CE marking’, provides:

‘Without prejudice to Article 8:

(a)

where a Member State establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established within the [European Union] shall be obliged to end the infringement under conditions imposed by the Member State;

| (b) | where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.’ |
| --- | --- |

(b)

where non-compliance continues, the Member State must take all appropriate measures to restrict or prohibit the placing on the market of the product in question or to ensure that it is withdrawn from the market, in accordance with the procedure in Article 8.’

| 7 | Annex I to Directive 93/42, entitled ‘Essential requirements’, includes part I, headed ‘General requirements’, which is worded as follows:





  ‘1. | The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. |
| --- | --- | --- |

7

Annex I to Directive 93/42, entitled ‘Essential requirements’, includes part I, headed ‘General requirements’, which is worded as follows:

‘1.

The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.

...

| 3. | The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1(2)(a), as specified by the manufacturer. |
| --- | --- |

3.

The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1(2)(a), as specified by the manufacturer.

...’

Background to the dispute

Background to the dispute

| 8 | The background to the dispute, as set out in paragraphs 1 to 20 of the judgment under appeal, may be summarised as follows. |
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8

The background to the dispute, as set out in paragraphs 1 to 20 of the judgment under appeal, may be summarised as follows.

| 9 | Mr Klein, the appellant, is the director of atmed AG, a limited company incorporated under German law which is currently insolvent. He is also the inventor of an inhalation-assisting device for persons suffering from asthma, which he patented at the beginning of the 1990s. |
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9

Mr Klein, the appellant, is the director of atmed AG, a limited company incorporated under German law which is currently insolvent. He is also the inventor of an inhalation-assisting device for persons suffering from asthma, which he patented at the beginning of the 1990s.

Prohibition decision relating to the Inhaler device

Prohibition decision relating to the Inhaler device

| 10 | From 1996 to 2001, manufacture of the appellant’s inhalation-assisting device was entrusted to Primed Halberstadt GmbH on behalf of Broncho-Air Medizintechnik AG. The latter company also distributed the device, under the name Inhaler Broncho Air® (‘the Inhaler device’). When it was placed on the German market, the device bore the CE marking, indicating that it conformed to the essential requirements of Directive 93/42. |
| --- | --- |

10

From 1996 to 2001, manufacture of the appellant’s inhalation-assisting device was entrusted to Primed Halberstadt GmbH on behalf of Broncho-Air Medizintechnik AG. The latter company also distributed the device, under the name Inhaler Broncho Air® (‘the Inhaler device’). When it was placed on the German market, the device bore the CE marking, indicating that it conformed to the essential requirements of Directive 93/42.

| 11 | In 1996, the German authorities sent Broncho-Air Medizintechnik a draft decision intended to prohibit the distribution of the Inhaler device. In that draft decision, the authorities stated that, due to the lack of an exhaustive clinical evaluation, they had doubts as to whether the device conformed to the essential requirements of Directive 93/42. They also expressed their intention to recall all instances of the device already placed on the market. |
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11

In 1996, the German authorities sent Broncho-Air Medizintechnik a draft decision intended to prohibit the distribution of the Inhaler device. In that draft decision, the authorities stated that, due to the lack of an exhaustive clinical evaluation, they had doubts as to whether the device conformed to the essential requirements of Directive 93/42. They also expressed their intention to recall all instances of the device already placed on the market.

| 12 | On 22 May 1997, Broncho-Air Medizintechnik sent the German authorities a letter informing them that the Inhaler device had not been placed on the market since 1 January 1997 and that its distribution would remain suspended until further trials and studies on the conformity of the product with Directive 93/42 were available. It also informed the German authorities that the device in question had not been distributed abroad (‘the letter of 22 May 1997’). |
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12

On 22 May 1997, Broncho-Air Medizintechnik sent the German authorities a letter informing them that the Inhaler device had not been placed on the market since 1 January 1997 and that its distribution would remain suspended until further trials and studies on the conformity of the product with Directive 93/42 were available. It also informed the German authorities that the device in question had not been distributed abroad (‘the letter of 22 May 1997’).

| 13 | On 23 September 1997, the German authorities adopted a decision prohibiting Primed Halberstadt from placing the Inhaler device on the market (‘the prohibition decision of 23 September 1997’). In that decision, the German authorities essentially stated that, pursuant to the opinion of the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products and Medical Devices, Germany), the Inhaler device did not meet the essential requirements laid down in Annex I to Directive 93/42 in so far as its safety had not been sufficiently established in a scientific manner in the light of information supplied by the manufacturer. |
| --- | --- |

13

On 23 September 1997, the German authorities adopted a decision prohibiting Primed Halberstadt from placing the Inhaler device on the market (‘the prohibition decision of 23 September 1997’). In that decision, the German authorities essentially stated that, pursuant to the opinion of the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for Medicinal Products and Medical Devices, Germany), the Inhaler device did not meet the essential requirements laid down in Annex I to Directive 93/42 in so far as its safety had not been sufficiently established in a scientific manner in the light of information supplied by the manufacturer.

| 14 | On 7 January 1998, the German authorities sent the Commission a letter headed ‘Safeguard clause procedure under Article 8 of Directive 93/42 relating to [the Inhaler device]’, in which it informed the Commission of its prohibition decision of 23 September 1997 (‘the letter of 7 January 1998’). |
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14

On 7 January 1998, the German authorities sent the Commission a letter headed ‘Safeguard clause procedure under Article 8 of Directive 93/42 relating to [the Inhaler device]’, in which it informed the Commission of its prohibition decision of 23 September 1997 (‘the letter of 7 January 1998’).

| 15 | The Commission did not adopt any decision following that notification by the German authorities. |
| --- | --- |

15

The Commission did not adopt any decision following that notification by the German authorities.

Prohibition decision relating to the effecto device

Prohibition decision relating to the effecto device

| 16 | On 16 June 2000, the exclusive rights to the appellant’s medical device were transferred to atmed. Following that transfer, that device was, from 2002, exclusively distributed by atmed under the name ‘effecto®’ (‘the effecto device’). In 2003, atmed also assumed responsibility for its manufacture. When it was placed on the German market, that device bore the CE marking, indicating that it conformed to the essential requirements of Directive 93/42. |
| --- | --- |

16

On 16 June 2000, the exclusive rights to the appellant’s medical device were transferred to atmed. Following that transfer, that device was, from 2002, exclusively distributed by atmed under the name ‘effecto®’ (‘the effecto device’). In 2003, atmed also assumed responsibility for its manufacture. When it was placed on the German market, that device bore the CE marking, indicating that it conformed to the essential requirements of Directive 93/42.

| 17 | On 18 May 2005, the German authorities adopted a decision prohibiting atmed from placing the effecto device on the market (‘the prohibition decision of 18 May 2005’). In essence, they considered that the conformity assessment procedure, in particular the clinical evaluation, had not been carried out properly and, for that reason, the device could not be deemed to satisfy the essential requirements of Directive 93/42. That decision was not notified to the Commission by the German authorities pursuant to Article 8(1) of Directive 93/42. |
| --- | --- |

17

On 18 May 2005, the German authorities adopted a decision prohibiting atmed from placing the effecto device on the market (‘the prohibition decision of 18 May 2005’). In essence, they considered that the conformity assessment procedure, in particular the clinical evaluation, had not been carried out properly and, for that reason, the device could not be deemed to satisfy the essential requirements of Directive 93/42. That decision was not notified to the Commission by the German authorities pursuant to Article 8(1) of Directive 93/42.

| 18 | On 16 January and 17 August 2006, atmed contacted the Commission to complain that the German authorities had not informed the Commission of the prohibition decision of 18 May 2005. According to atmed, a safeguard clause procedure should have been initiated under Article 8 of Directive 93/42. |
| --- | --- |

18

On 16 January and 17 August 2006, atmed contacted the Commission to complain that the German authorities had not informed the Commission of the prohibition decision of 18 May 2005. According to atmed, a safeguard clause procedure should have been initiated under Article 8 of Directive 93/42.

| 19 | On 6 October 2006, in the light of the information received from atmed, the Commission asked the German authorities whether, in their view, the conditions for a safeguard clause procedure under Article 8(1) of Directive 93/42 were met. |
| --- | --- |

19

On 6 October 2006, in the light of the information received from atmed, the Commission asked the German authorities whether, in their view, the conditions for a safeguard clause procedure under Article 8(1) of Directive 93/42 were met.

| 20 | On 12 December 2006, the Federal Republic of Germany explained to the Commission that it believed the procedure initiated by the letter of 7 January 1998, in respect of the Inhaler device, constituted a safeguard clause procedure within the meaning of that provision (‘the safeguard clause procedure of 1998’) and that initiation of a new procedure, for the same device under another name, was not justified. Moreover, the German authorities informed the Commission of their continuing doubts regarding the conformity of the effecto device with the essential requirements of Directive 93/42 and, therefore, asked the Commission to confirm their prohibition decision of 18 May 2005. On 13 December 2006, the Commission informed atmed of the German authorities’ response. |
| --- | --- |

20

On 12 December 2006, the Federal Republic of Germany explained to the Commission that it believed the procedure initiated by the letter of 7 January 1998, in respect of the Inhaler device, constituted a safeguard clause procedure within the meaning of that provision (‘the safeguard clause procedure of 1998’) and that initiation of a new procedure, for the same device under another name, was not justified. Moreover, the German authorities informed the Commission of their continuing doubts regarding the conformity of the effecto device with the essential requirements of Directive 93/42 and, therefore, asked the Commission to confirm their prohibition decision of 18 May 2005. On 13 December 2006, the Commission informed atmed of the German authorities’ response.

| 21 | On 18 December 2006, atmed asked the Commission to take proceedings against the Federal Republic of Germany for failure to fulfil an obligation under Article 226 EC and to pursue the safeguard clause procedure which, it said, had been activated in 1998 (‘atmed’s email of 18 December 2006’). |
| --- | --- |

21

On 18 December 2006, atmed asked the Commission to take proceedings against the Federal Republic of Germany for failure to fulfil an obligation under Article 226 EC and to pursue the safeguard clause procedure which, it said, had been activated in 1998 (‘atmed’s email of 18 December 2006’).

| 22 | On 22 February 2007, the Commission proposed to the German authorities to assess the decision of 18 May 2005 in the context of the safeguard clause procedure of 1998 and handle it on the basis of the new information. According to the Commission, that would avoid the need for a new notification and improve efficiency. |
| --- | --- |

22

On 22 February 2007, the Commission proposed to the German authorities to assess the decision of 18 May 2005 in the context of the safeguard clause procedure of 1998 and handle it on the basis of the new information. According to the Commission, that would avoid the need for a new notification and improve efficiency.

| 23 | On 18 July 2007, the Commission informed the German authorities it had concluded that the situation they had brought before it was in fact a case of a wrongly affixed CE marking which therefore needed to be dealt with under Article 18 of Directive 93/42. In that regard, the Commission called into question the premiss that the effecto device was not capable of fulfilling the essential requirements laid down in that directive. On the other hand, it considered that further clinical data were necessary to prove that the effecto device complied with the said requirements and invited the German authorities to cooperate closely with atmed in order to establish what data were missing. The Commission provided the appellant with a copy of its letter to the German authorities in that regard. |
| --- | --- |

23

On 18 July 2007, the Commission informed the German authorities it had concluded that the situation they had brought before it was in fact a case of a wrongly affixed CE marking which therefore needed to be dealt with under Article 18 of Directive 93/42. In that regard, the Commission called into question the premiss that the effecto device was not capable of fulfilling the essential requirements laid down in that directive. On the other hand, it considered that further clinical data were necessary to prove that the effecto device complied with the said requirements and invited the German authorities to cooperate closely with atmed in order to establish what data were missing. The Commission provided the appellant with a copy of its letter to the German authorities in that regard.

| 24 | In 2008, the appellant presented a petition to the European Parliament concerning the failure of the Commission to take sufficient action in his case. On 19 January 2011, the Parliament adopted resolution P7_TA(2011) 0017. |
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24

In 2008, the appellant presented a petition to the European Parliament concerning the failure of the Commission to take sufficient action in his case. On 19 January 2011, the Parliament adopted resolution P7_TA(2011) 0017.

| 25 | On 9 March 2011, the appellant asked the Commission to pay compensation of EUR 170 million to atmed and EUR 130 million to him personally. On 11 March 2011, the Commission rejected that claim for compensation submitted by the appellant. |
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25

On 9 March 2011, the appellant asked the Commission to pay compensation of EUR 170 million to atmed and EUR 130 million to him personally. On 11 March 2011, the Commission rejected that claim for compensation submitted by the appellant.

Proceedings before the General Court and the Court of Justice

Proceedings before the General Court and the Court of Justice

| 26 | By application lodged at the Registry of the General Court on 15 September 2011, the appellant brought an action seeking compensation on the basis of the combined provisions of Article 268 TFEU and the second paragraph of Article 340 TFEU. |
| --- | --- |

26

By application lodged at the Registry of the General Court on 15 September 2011, the appellant brought an action seeking compensation on the basis of the combined provisions of Article 268 TFEU and the second paragraph of Article 340 TFEU.

| 27 | By judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), the General Court dismissed that action on the ground that the Commission had not acted unlawfully under the provisions of Directive 93/42. |
| --- | --- |

27

By judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), the General Court dismissed that action on the ground that the Commission had not acted unlawfully under the provisions of Directive 93/42.

| 28 | First of all, the General Court declared inadmissible, on the ground that it was time-barred, the appellant’s claim relating to the damage allegedly sustained before 15 September 2006. Next, as regards the prohibition in relation to the Inhaler device, the General Court considered that the Commission’s failure to act was not unlawful since, in spite of the title of the letter of 7 January 1998, that prohibition did not relate to a safeguard clause procedure within the meaning of Article 8(2) of Directive 93/42, but related rather to a wrongly affixed CE marking within the meaning of Article 18 of that directive. According to the General Court, pursuant to Article 8(3) of that directive, the Member State concerned was required to inform the Commission of such a situation but the latter was not required to adopt a decision. Lastly, as regards the prohibition in relation to the effecto device, the General Court rejected the appellant’s arguments to the effect that the Commission should have initiated a safeguard clause procedure under Article 8(2) of Directive 93/42 of its own motion or should have, at least, initiated infringement proceedings under Article 226 EC. |
| --- | --- |

28

First of all, the General Court declared inadmissible, on the ground that it was time-barred, the appellant’s claim relating to the damage allegedly sustained before 15 September 2006. Next, as regards the prohibition in relation to the Inhaler device, the General Court considered that the Commission’s failure to act was not unlawful since, in spite of the title of the letter of 7 January 1998, that prohibition did not relate to a safeguard clause procedure within the meaning of Article 8(2) of Directive 93/42, but related rather to a wrongly affixed CE marking within the meaning of Article 18 of that directive. According to the General Court, pursuant to Article 8(3) of that directive, the Member State concerned was required to inform the Commission of such a situation but the latter was not required to adopt a decision. Lastly, as regards the prohibition in relation to the effecto device, the General Court rejected the appellant’s arguments to the effect that the Commission should have initiated a safeguard clause procedure under Article 8(2) of Directive 93/42 of its own motion or should have, at least, initiated infringement proceedings under Article 226 EC.

| 29 | Following the appellant’s appeal, the Court of Justice, by judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), set aside in part the judgment of the General Court of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) and referred the case back to that Court. |
| --- | --- |

29

Following the appellant’s appeal, the Court of Justice, by judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), set aside in part the judgment of the General Court of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) and referred the case back to that Court.

| 30 | First, the Court of Justice dismissed the appellant’s appeal in so far as it sought damages for the period before 15 September 2006. Secondly, as regards the decision prohibiting the placing on the market of the Inhaler device, the Court of Justice held that the General Court had misconstrued Articles 8 and 18 of Directive 93/42 in finding that the Commission had not failed to fulfil its obligations under that directive. In particular, it considered that the General Court had erred in law in holding that the Commission had not been under an obligation to initiate a safeguard clause procedure, in accordance with Article 8 of Directive 93/42, following receipt of the letter of 7 January 1998. In addition, the Court of Justice considered that the possible application of Article 18 of Directive 93/42 to the Inhaler device did not release the Commission from the obligation to act pursuant to Article 8(2) of that directive. As regards the prohibition in relation to the effecto device, the Court of Justice rejected as inadmissible the appellant’s fourth ground of appeal which sought to establish that the General Court had erred in that part of the judgment. |
| --- | --- |

30

First, the Court of Justice dismissed the appellant’s appeal in so far as it sought damages for the period before 15 September 2006. Secondly, as regards the decision prohibiting the placing on the market of the Inhaler device, the Court of Justice held that the General Court had misconstrued Articles 8 and 18 of Directive 93/42 in finding that the Commission had not failed to fulfil its obligations under that directive. In particular, it considered that the General Court had erred in law in holding that the Commission had not been under an obligation to initiate a safeguard clause procedure, in accordance with Article 8 of Directive 93/42, following receipt of the letter of 7 January 1998. In addition, the Court of Justice considered that the possible application of Article 18 of Directive 93/42 to the Inhaler device did not release the Commission from the obligation to act pursuant to Article 8(2) of that directive. As regards the prohibition in relation to the effecto device, the Court of Justice rejected as inadmissible the appellant’s fourth ground of appeal which sought to establish that the General Court had erred in that part of the judgment.

The judgment under appeal

The judgment under appeal

| 31 | It is apparent from paragraphs 32 to 36 of the judgment under appeal that, by its second head of claim, the appellant had requested the General Court to declare that the Commission should pay him compensation, not only on account of its failure to act in the safeguard clause procedure of 1998, in relation to the Inhaler device, but also in relation to the effecto device. In paragraph 36 of the judgment under appeal, the General Court declared that head of claim to be inadmissible in so far as it alleged an unlawful failure to act on the part of the Commission in the procedure relating to the effecto device. |
| --- | --- |

31

It is apparent from paragraphs 32 to 36 of the judgment under appeal that, by its second head of claim, the appellant had requested the General Court to declare that the Commission should pay him compensation, not only on account of its failure to act in the safeguard clause procedure of 1998, in relation to the Inhaler device, but also in relation to the effecto device. In paragraph 36 of the judgment under appeal, the General Court declared that head of claim to be inadmissible in so far as it alleged an unlawful failure to act on the part of the Commission in the procedure relating to the effecto device.

| 32 | In relation to the conditions necessary for the Union to incur non-contractual liability, the General Court held, in paragraph 57 of the judgment under appeal, that since, first, the Commission had no discretion as to the adoption of a decision following the initiation, in accordance with Article 8(2) of Directive 93/42, of the safeguard clause procedure of 1998, and, secondly, an administrative authority exercising ordinary care and diligence, should not, in such circumstances, have committed the unlawful conduct established, the breach of EU law by the Commission had to be regarded as being ‘sufficiently serious’. |
| --- | --- |

32

In relation to the conditions necessary for the Union to incur non-contractual liability, the General Court held, in paragraph 57 of the judgment under appeal, that since, first, the Commission had no discretion as to the adoption of a decision following the initiation, in accordance with Article 8(2) of Directive 93/42, of the safeguard clause procedure of 1998, and, secondly, an administrative authority exercising ordinary care and diligence, should not, in such circumstances, have committed the unlawful conduct established, the breach of EU law by the Commission had to be regarded as being ‘sufficiently serious’.

| 33 | As regards the question whether Article 8 of Directive 93/42 confers on the appellant any rights, the General Court, in paragraph 67 of the judgment under appeal, held that the appellant could rely only on the rights to compensation that had been transferred to him by Broncho-Air Medizintechnik, and could not rely on rights to compensation associated with his personal situation or atmed, since the standard of protection referred to in Article 8(2) of Directive 93/42 does not cover those rights. |
| --- | --- |

33

As regards the question whether Article 8 of Directive 93/42 confers on the appellant any rights, the General Court, in paragraph 67 of the judgment under appeal, held that the appellant could rely only on the rights to compensation that had been transferred to him by Broncho-Air Medizintechnik, and could not rely on rights to compensation associated with his personal situation or atmed, since the standard of protection referred to in Article 8(2) of Directive 93/42 does not cover those rights.

| 34 | As concerns the causal link, the General Court found, in paragraph 73 of the judgment under appeal, that even if all the damage the appellant claimed to have suffered were proven, the existence of a direct causal link could not, in any event, be established between that damage and the Commission’s unlawful conduct. In that regard, the General Court, in the first place, considered:





  ‘74. | ... It should be noted that Broncho-Air Medizintechnik had informed the German authorities, by letter of 22 May 1997, of its intention to voluntarily cease the sale of the Inhaler device until further trials and studies on the conformity of that device with Directive 93/42 became available. Furthermore, according to that letter, the Inhaler device had not, by decision of the distributing company, been placed on the market since 1 January 1997 and had not been marketed in any Member State other than [the Federal Republic of Germany]. The letter stated in conclusion that the German authorities and the Federal Institute for Medicinal Products and Medical Devices would be contacted again as soon as new information concerning the safety of the device became available. |
| --- | --- | --- |

34

As concerns the causal link, the General Court found, in paragraph 73 of the judgment under appeal, that even if all the damage the appellant claimed to have suffered were proven, the existence of a direct causal link could not, in any event, be established between that damage and the Commission’s unlawful conduct. In that regard, the General Court, in the first place, considered:

‘74.

... It should be noted that Broncho-Air Medizintechnik had informed the German authorities, by letter of 22 May 1997, of its intention to voluntarily cease the sale of the Inhaler device until further trials and studies on the conformity of that device with Directive 93/42 became available. Furthermore, according to that letter, the Inhaler device had not, by decision of the distributing company, been placed on the market since 1 January 1997 and had not been marketed in any Member State other than [the Federal Republic of Germany]. The letter stated in conclusion that the German authorities and the Federal Institute for Medicinal Products and Medical Devices would be contacted again as soon as new information concerning the safety of the device became available.

| 75 | It follows that cessation of placing on the market and selling of the Inhaler device took place, as noted by the Commission and the Federal Republic of Germany, before adoption, on 23 September 1997, of the decision prohibiting marketing of that device and before the Commission was informed of that decision, in accordance with Article 8(1) of Directive 93/42, on 7 January 1998. The damage alleged by the applicant, which inter alia consists, according to him, in loss of sales of the Inhaler device and other claims arising from that loss of sales, therefore resulted from the decision taken, on its own initiative, by Broncho-Air Medizintechnik and not from the Commission’s alleged failure to act. Furthermore, it must be held, contrary to the submissions of the applicant, that it is irrelevant in that regard that the Commission only became aware of that cessation of sales at a later stage in the procedure. |
| --- | --- |

75

It follows that cessation of placing on the market and selling of the Inhaler device took place, as noted by the Commission and the Federal Republic of Germany, before adoption, on 23 September 1997, of the decision prohibiting marketing of that device and before the Commission was informed of that decision, in accordance with Article 8(1) of Directive 93/42, on 7 January 1998. The damage alleged by the applicant, which inter alia consists, according to him, in loss of sales of the Inhaler device and other claims arising from that loss of sales, therefore resulted from the decision taken, on its own initiative, by Broncho-Air Medizintechnik and not from the Commission’s alleged failure to act. Furthermore, it must be held, contrary to the submissions of the applicant, that it is irrelevant in that regard that the Commission only became aware of that cessation of sales at a later stage in the procedure.

| 76 | Moreover, although the applicant claims that the Inhaler device was not distributed from 1997 onwards due to the prohibition decision [of 23 September 1997] and to the Commission’s failure to act, it is clear that such an argument is contradicted by atmed’s statements in the email it sent to the Commission on 18 December 2006, which confirms cessation of distribution of the Inhaler device was voluntary. It should be noted that, in that email, atmed explained that “[the safeguard clause procedure of 1998] became devoid of purpose shortly after the letter of [7 January 1998] since the then manufacturer had stated that it would no longer market the device until additional studies had proved it was safe”. That email also noted that a statement to that effect had been made “orally before the German authorities in January 1997 and confirmed in writing on 22 May 1997”.’ |
| --- | --- |

76

Moreover, although the applicant claims that the Inhaler device was not distributed from 1997 onwards due to the prohibition decision [of 23 September 1997] and to the Commission’s failure to act, it is clear that such an argument is contradicted by atmed’s statements in the email it sent to the Commission on 18 December 2006, which confirms cessation of distribution of the Inhaler device was voluntary. It should be noted that, in that email, atmed explained that “[the safeguard clause procedure of 1998] became devoid of purpose shortly after the letter of [7 January 1998] since the then manufacturer had stated that it would no longer market the device until additional studies had proved it was safe”. That email also noted that a statement to that effect had been made “orally before the German authorities in January 1997 and confirmed in writing on 22 May 1997”.’

| 35 | In paragraph 78 of the judgment under appeal, the General Court, in its assessment of the causal link, considered in the second place that the argument that the Commission would, in any event, have adopted a decision contrary to the finding of the German authorities could not be upheld. |
| --- | --- |

35

In paragraph 78 of the judgment under appeal, the General Court, in its assessment of the causal link, considered in the second place that the argument that the Commission would, in any event, have adopted a decision contrary to the finding of the German authorities could not be upheld.

| 36 | In that regard, at the end of its analysis, the General Court found, in paragraph 81 of the judgment under appeal, that it was not certain that the Commission would have adopted a decision to the effect alleged by the appellant and that, moreover, given that the appellant’s argument relating to the outcome of the safeguard clause procedure of 1998 was based on purely hypothetical assertions, the existence of a causal link could not be established in that instance. |
| --- | --- |

36

In that regard, at the end of its analysis, the General Court found, in paragraph 81 of the judgment under appeal, that it was not certain that the Commission would have adopted a decision to the effect alleged by the appellant and that, moreover, given that the appellant’s argument relating to the outcome of the safeguard clause procedure of 1998 was based on purely hypothetical assertions, the existence of a causal link could not be established in that instance.

| 37 | The General Court added, in paragraph 82 of the judgment under appeal, that the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts, were incurred on his own initiative for the purpose of challenging the legality of the decisions of the German authorities and, accordingly, their reimbursement could not legitimately be claimed from the Commission. |
| --- | --- |

37

The General Court added, in paragraph 82 of the judgment under appeal, that the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts, were incurred on his own initiative for the purpose of challenging the legality of the decisions of the German authorities and, accordingly, their reimbursement could not legitimately be claimed from the Commission.

| 38 | In those circumstances, the General Court concluded, in paragraphs 83 and 84 of the judgment under appeal, that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability and that, since the absence of only one of the conditions necessary to give rise to such liability was sufficient to reject the claim for compensation, the action had to be dismissed in its entirety without it being necessary to examine the condition relating to the existence of damage. |
| --- | --- |

38

In those circumstances, the General Court concluded, in paragraphs 83 and 84 of the judgment under appeal, that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability and that, since the absence of only one of the conditions necessary to give rise to such liability was sufficient to reject the claim for compensation, the action had to be dismissed in its entirety without it being necessary to examine the condition relating to the existence of damage.

Forms of order sought by the parties before the Court of Justice

Forms of order sought by the parties before the Court of Justice

| 39 | By his appeal, the appellant claims that the Court of Justice should:





  – | set aside the judgment under appeal; |
| --- | --- | --- |

39

By his appeal, the appellant claims that the Court of Justice should:

–

set aside the judgment under appeal;

| – | order the Commission to pay him damages in the sum of EUR 1562 662.30, plus interest at 8 percentage points over the basic interest rate as from delivery of the judgment; |
| --- | --- |

–

order the Commission to pay him damages in the sum of EUR 1562 662.30, plus interest at 8 percentage points over the basic interest rate as from delivery of the judgment;

| – | declare that the Commission is under an obligation to compensate the appellant for the damage caused to him from 15 September 2006, which he continues to claim and which still remains to be quantified; |
| --- | --- |

–

declare that the Commission is under an obligation to compensate the appellant for the damage caused to him from 15 September 2006, which he continues to claim and which still remains to be quantified;

| – | order the Commission to pay the costs; and |
| --- | --- |

–

order the Commission to pay the costs; and

| – | in the alternative, set aside the judgment under appeal and refer the case back to the General Court. |
| --- | --- |

–

in the alternative, set aside the judgment under appeal and refer the case back to the General Court.

| 40 | The Commission requests the Court of Justice to dismiss the appeal as unfounded and to order the appellant to pay all the costs. |
| --- | --- |

40

The Commission requests the Court of Justice to dismiss the appeal as unfounded and to order the appellant to pay all the costs.

The appeal

The appeal

| 41 | In support of his appeal, the appellant raises, in essence, seven grounds of appeal, alleging, first, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court was wrong to rule that the appellant’s second head of claim was inadmissible, secondly, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court erred in its assessment of the conditions to be satisfied in an action for damages, thirdly, infringement of Article 84(1) of the Rules of Procedure of the General Court in so far as the General Court was wrong to reject, on the basis that it was a new submission, the plea alleging infringement of Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and of the principle of sound administration, fourthly, infringement of Article 8 of Directive 93/42 and Articles 28 et seq. TFEU in so far as those provisions confer rights on individuals, fifthly, an error committed by the General Court in its examination of a causal link between the Commission’s conduct and the alleged damage, sixthly, failure to take account of a draft Commission Decision, and seventhly, infringement of Article 6 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) and of Article 47 of the Charter in so far as the General Court was wrong to reject the request for further evidence submitted by the appellant. |
| --- | --- |

41

In support of his appeal, the appellant raises, in essence, seven grounds of appeal, alleging, first, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court was wrong to rule that the appellant’s second head of claim was inadmissible, secondly, infringement of the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union in so far as the General Court erred in its assessment of the conditions to be satisfied in an action for damages, thirdly, infringement of Article 84(1) of the Rules of Procedure of the General Court in so far as the General Court was wrong to reject, on the basis that it was a new submission, the plea alleging infringement of Article 41 of the Charter of Fundamental Rights of the European Union (‘the Charter’) and of the principle of sound administration, fourthly, infringement of Article 8 of Directive 93/42 and Articles 28 et seq. TFEU in so far as those provisions confer rights on individuals, fifthly, an error committed by the General Court in its examination of a causal link between the Commission’s conduct and the alleged damage, sixthly, failure to take account of a draft Commission Decision, and seventhly, infringement of Article 6 of the European Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950 (‘the ECHR’) and of Article 47 of the Charter in so far as the General Court was wrong to reject the request for further evidence submitted by the appellant.

| 42 | In addition, on the basis of Article 41 of the Charter, the appellant requests that the Court of Justice order the Commission to produce its entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42. |
| --- | --- |

42

In addition, on the basis of Article 41 of the Charter, the appellant requests that the Court of Justice order the Commission to produce its entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42.

The first ground of appeal

The first ground of appeal

Arguments of the parties

Arguments of the parties

| 43 | The appellant notes that he challenged, before the Court of Justice, the finding made by the General Court in the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) to the effect that, in the absence of a formal notification regarding the effecto device from the German authorities, the Commission was not under any obligation to adopt a decision under Article 8(2) of Directive 93/42. |
| --- | --- |

43

The appellant notes that he challenged, before the Court of Justice, the finding made by the General Court in the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) to the effect that, in the absence of a formal notification regarding the effecto device from the German authorities, the Commission was not under any obligation to adopt a decision under Article 8(2) of Directive 93/42.

| 44 | Given that the Court of Justice rejected that ground of appeal as inadmissible in its judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), it follows that that finding made by the General Court has become final, pursuant to the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union. |
| --- | --- |

44

Given that the Court of Justice rejected that ground of appeal as inadmissible in its judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), it follows that that finding made by the General Court has become final, pursuant to the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union.

| 45 | Nevertheless, the appellant argues that the fact that the Court of Justice rejected that ground of appeal does not mean that he cannot claim damages in relation to the effecto device. In his view, the absence of non-contractual liability on the part of the European Union in relation to that device does not constitute a point of law decided by the Court of Justice in that appeal judgment. The finding that the Commission should have adopted a decision under Article 8 of Directive 93/42 and that, in that respect, its conduct was unlawful, was made final by the Court of Justice, with the consequence that the effects of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252) also relate to the effecto device. |
| --- | --- |

45

Nevertheless, the appellant argues that the fact that the Court of Justice rejected that ground of appeal does not mean that he cannot claim damages in relation to the effecto device. In his view, the absence of non-contractual liability on the part of the European Union in relation to that device does not constitute a point of law decided by the Court of Justice in that appeal judgment. The finding that the Commission should have adopted a decision under Article 8 of Directive 93/42 and that, in that respect, its conduct was unlawful, was made final by the Court of Justice, with the consequence that the effects of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252) also relate to the effecto device.

| 46 | In paragraphs 32 to 36 of the judgment under appeal, the General Court inferred from that judgment of the Court of Justice that the second head of claim, by which the appellant requested the General Court to order the Commission to pay him compensation, not only on account of its failure to act in the safeguard clause procedure of 1998, in relation to the Inhaler device, but also on account of its failure to act in relation to the effecto device, had to be declared inadmissible. |
| --- | --- |

46

In paragraphs 32 to 36 of the judgment under appeal, the General Court inferred from that judgment of the Court of Justice that the second head of claim, by which the appellant requested the General Court to order the Commission to pay him compensation, not only on account of its failure to act in the safeguard clause procedure of 1998, in relation to the Inhaler device, but also on account of its failure to act in relation to the effecto device, had to be declared inadmissible.

| 47 | Furthermore, it is clear from the operative part of that judgment of the Court of Justice that that Court made no distinction between the Inhaler and effecto device. Thus, the appellant claims that, as regards the conditions required for a right to compensation, the operative part of that judgment covers all the damage the appellant has sustained on account of the infringement of his personal rights and of the rights transferred to him in connection with both the Inhaler and effecto device. |
| --- | --- |

47

Furthermore, it is clear from the operative part of that judgment of the Court of Justice that that Court made no distinction between the Inhaler and effecto device. Thus, the appellant claims that, as regards the conditions required for a right to compensation, the operative part of that judgment covers all the damage the appellant has sustained on account of the infringement of his personal rights and of the rights transferred to him in connection with both the Inhaler and effecto device.

| 48 | The Commission contends that that first ground of appeal is unfounded. |
| --- | --- |

48

The Commission contends that that first ground of appeal is unfounded.

Findings of the Court

Findings of the Court

| 49 | Pursuant to the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union, where a case is referred back to the General Court, that Court is to be bound by the decision of the Court of Justice on points of law. |
| --- | --- |

49

Pursuant to the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union, where a case is referred back to the General Court, that Court is to be bound by the decision of the Court of Justice on points of law.

| 50 | In that respect, it should be noted that, in its judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), the General Court rejected the appellant’s claim that, in relation to the effecto device, the Commission should have adopted a decision under Article 8(2) of Directive 93/42, despite the absence of a formal notification from the German authorities. |
| --- | --- |

50

In that respect, it should be noted that, in its judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), the General Court rejected the appellant’s claim that, in relation to the effecto device, the Commission should have adopted a decision under Article 8(2) of Directive 93/42, despite the absence of a formal notification from the German authorities.

| 51 | In his application in the case that gave rise to the judgment of 22 April 2015, Klein v Commission, C‐120/14 P, not published, EU:C:2015:252), the appellant raised a fourth ground of appeal, based on the absence of a Commission decision concerning the effecto device, in challenging the solution adopted by the General Court in that regard. |
| --- | --- |

51

In his application in the case that gave rise to the judgment of 22 April 2015, Klein v Commission, C‐120/14 P, not published, EU:C:2015:252), the appellant raised a fourth ground of appeal, based on the absence of a Commission decision concerning the effecto device, in challenging the solution adopted by the General Court in that regard.

| 52 | In paragraphs 87 and 88 of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the Court of Justice held that the appellant had not clearly identified the points in the grounds of the judgment under appeal that were contested in the context of the fourth ground of appeal nor, a fortiori, the error of law allegedly vitiating that part of the judgment under appeal. Accordingly, the Court of Justice held that the fourth ground of appeal had to be rejected as inadmissible. |
| --- | --- |

52

In paragraphs 87 and 88 of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the Court of Justice held that the appellant had not clearly identified the points in the grounds of the judgment under appeal that were contested in the context of the fourth ground of appeal nor, a fortiori, the error of law allegedly vitiating that part of the judgment under appeal. Accordingly, the Court of Justice held that the fourth ground of appeal had to be rejected as inadmissible.

| 53 | Consequently, by rejecting that ground of appeal as inadmissible on the basis that it lacked clarity, the Court of Justice made final the point of law decided in the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) relating to the Commission’s conduct in connection with the effecto device. |
| --- | --- |

53

Consequently, by rejecting that ground of appeal as inadmissible on the basis that it lacked clarity, the Court of Justice made final the point of law decided in the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) relating to the Commission’s conduct in connection with the effecto device.

| 54 | The mere fact that, in paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission, C‐120/14 P, not published, EU:C:2015:252), the Court of Justice did not distinguish between the Inhaler and effecto devices is not capable of altering that conclusion. |
| --- | --- |

54

The mere fact that, in paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission, C‐120/14 P, not published, EU:C:2015:252), the Court of Justice did not distinguish between the Inhaler and effecto devices is not capable of altering that conclusion.

| 55 | Consequently, in the judgment under appeal, the General Court rightly rejected as inadmissible the second head of claim by which the appellant requested the General Court to declare that the Commission should also pay him compensation on account of that institution’s failure to act in relation to the effecto device. |
| --- | --- |

55

Consequently, in the judgment under appeal, the General Court rightly rejected as inadmissible the second head of claim by which the appellant requested the General Court to declare that the Commission should also pay him compensation on account of that institution’s failure to act in relation to the effecto device.

| 56 | In those circumstances, the first ground of appeal must be rejected as unfounded. |
| --- | --- |

56

In those circumstances, the first ground of appeal must be rejected as unfounded.

The second ground of appeal

The second ground of appeal

Arguments of the parties

Arguments of the parties

| 57 | The appellant argues, on the basis of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), that the Court of Justice has already ruled that there was a sufficiently serious breach of Article 8 of Directive 93/42 and that that article confers rights on individuals. According to the appellant, the words ‘damage allegedly sustained’, as contained in paragraph 1 of the operative part, should be understood to mean that, in the judgment to be delivered after the case was referred back to the General Court, that Court was only to verify whether that damage had been established. |
| --- | --- |

57

The appellant argues, on the basis of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), that the Court of Justice has already ruled that there was a sufficiently serious breach of Article 8 of Directive 93/42 and that that article confers rights on individuals. According to the appellant, the words ‘damage allegedly sustained’, as contained in paragraph 1 of the operative part, should be understood to mean that, in the judgment to be delivered after the case was referred back to the General Court, that Court was only to verify whether that damage had been established.

| 58 | The fact that, in the judgment under appeal, the General Court conducted a new assessment of the non-contractual liability of the European Union and concluded that the appellant could not rely on rights to compensation associated with his personal situation or on the rights to compensation that had been transferred to him by atmed, amounts, in the view of the appellant, to depriving the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252) of its binding effect. Thus the appellant claims that, in its examination of the conditions to be satisfied in an action for damages, the General Court infringed the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union. |
| --- | --- |

58

The fact that, in the judgment under appeal, the General Court conducted a new assessment of the non-contractual liability of the European Union and concluded that the appellant could not rely on rights to compensation associated with his personal situation or on the rights to compensation that had been transferred to him by atmed, amounts, in the view of the appellant, to depriving the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252) of its binding effect. Thus the appellant claims that, in its examination of the conditions to be satisfied in an action for damages, the General Court infringed the second paragraph of Article 61 of the Statute of the Court of Justice of the European Union.

| 59 | The Commission contends that that second ground of appeal is unfounded. |
| --- | --- |

59

The Commission contends that that second ground of appeal is unfounded.

Findings of the Court

Findings of the Court

| 60 | According to the settled case-law of the Court of Justice, the European Union’s non-contractual liability under the second paragraph of Article 340 TFEU is subject to the satisfaction of a number of conditions, namely the unlawfulness of the conduct alleged against the EU institution, the establishment of actual damage and the existence of a causal link between the conduct of the institution and the damage complained of (judgment of 14 October 2014, Giordano v Commission, C‐611/12 P, EU:C:2014:2282, paragraph 35 and case-law cited). |
| --- | --- |

60

According to the settled case-law of the Court of Justice, the European Union’s non-contractual liability under the second paragraph of Article 340 TFEU is subject to the satisfaction of a number of conditions, namely the unlawfulness of the conduct alleged against the EU institution, the establishment of actual damage and the existence of a causal link between the conduct of the institution and the damage complained of (judgment of 14 October 2014, Giordano v Commission, C‐611/12 P, EU:C:2014:2282, paragraph 35 and case-law cited).

| 61 | As regards the first condition, the Court of Justice has already stated on many occasions that a sufficiently serious breach of a rule of law intended to confer rights on individuals must be established (see, to that effect, judgments of 4 July 2000, Bergaderm and Goupil v Commission, C‐352/98 P, EU:C:2000:361, paragraph 42, and of 10 July 2014, Nikolaou v Court of Auditors, C‐220/13 P, EU:C:2014:2057, paragraph 53). |
| --- | --- |

61

As regards the first condition, the Court of Justice has already stated on many occasions that a sufficiently serious breach of a rule of law intended to confer rights on individuals must be established (see, to that effect, judgments of 4 July 2000, Bergaderm and Goupil v Commission, C‐352/98 P, EU:C:2000:361, paragraph 42, and of 10 July 2014, Nikolaou v Court of Auditors, C‐220/13 P, EU:C:2014:2057, paragraph 53).

| 62 | The appellant argues, on the basis of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), that the Court of Justice has already ruled that there was a sufficiently serious breach of Article 8 of Directive 93/42 and that that article confers rights on individuals. Accordingly, in the judgment under appeal, the General Court was not entitled to reassess that condition which is required to establish the non-contractual liability of the European Union. |
| --- | --- |

62

The appellant argues, on the basis of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), that the Court of Justice has already ruled that there was a sufficiently serious breach of Article 8 of Directive 93/42 and that that article confers rights on individuals. Accordingly, in the judgment under appeal, the General Court was not entitled to reassess that condition which is required to establish the non-contractual liability of the European Union.

| 63 | In that respect, it should be recalled that, in the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the Court of Justice assessed, in the context of the second plea advanced by the appellant which alleged incorrect application of Articles 8 and 18 of Directive 93/42, whether the Commission was under an obligation to act following receipt of the letter of 7 January 1998. In conclusion to that assessment, the Court of Justice ruled that the General Court had misconstrued Articles 8 and 18 of Directive 93/42 in its judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19). |
| --- | --- |

63

In that respect, it should be recalled that, in the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the Court of Justice assessed, in the context of the second plea advanced by the appellant which alleged incorrect application of Articles 8 and 18 of Directive 93/42, whether the Commission was under an obligation to act following receipt of the letter of 7 January 1998. In conclusion to that assessment, the Court of Justice ruled that the General Court had misconstrued Articles 8 and 18 of Directive 93/42 in its judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19).

| 64 | Whilst the Court of Justice found that the General Court had misconstrued Articles 8 and 18 of Directive 93/42, it did not examine the conditions for establishing non-contractual liability on the part of the European Union, and in particular, it did not examine the first of those conditions which requires the existence of a sufficiently serious breach of a rule of law intended to confer rights on individuals. Indeed, no reference to that condition was made in that judgment. |
| --- | --- |

64

Whilst the Court of Justice found that the General Court had misconstrued Articles 8 and 18 of Directive 93/42, it did not examine the conditions for establishing non-contractual liability on the part of the European Union, and in particular, it did not examine the first of those conditions which requires the existence of a sufficiently serious breach of a rule of law intended to confer rights on individuals. Indeed, no reference to that condition was made in that judgment.

| 65 | Therefore, the wording of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), which set aside the judgment of the General Court of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), ‘in so far as, by that judgment, the General Court dismissed the action in that it sought that the European Commission be ordered to pay compensation for the damage allegedly suffered by Mr Christoph Klein from 15 September 2006’, cannot be interpreted as meaning that the Court of Justice, in the context of its examination, acknowledged that the first condition for the incurrence of non-contractual liability on the part of the European Union had been met in the present case. |
| --- | --- |

65

Therefore, the wording of paragraph 1 of the operative part of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), which set aside the judgment of the General Court of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), ‘in so far as, by that judgment, the General Court dismissed the action in that it sought that the European Commission be ordered to pay compensation for the damage allegedly suffered by Mr Christoph Klein from 15 September 2006’, cannot be interpreted as meaning that the Court of Justice, in the context of its examination, acknowledged that the first condition for the incurrence of non-contractual liability on the part of the European Union had been met in the present case.

| 66 | Consequently, in criticising the General Court for examining, in the judgment under appeal, whether the Commission had committed a sufficiently serious breach of Article 8 of Directive 93/42 and whether that article confers rights on individuals, the appellant has misinterpreted the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), and, in particular, the operative part of that judgment. |
| --- | --- |

66

Consequently, in criticising the General Court for examining, in the judgment under appeal, whether the Commission had committed a sufficiently serious breach of Article 8 of Directive 93/42 and whether that article confers rights on individuals, the appellant has misinterpreted the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), and, in particular, the operative part of that judgment.

| 67 | Accordingly, the second ground of appeal must be rejected as unfounded. |
| --- | --- |

67

Accordingly, the second ground of appeal must be rejected as unfounded.

The third, sixth and seventh grounds of appeal

The third, sixth and seventh grounds of appeal

Arguments of the parties

Arguments of the parties

| 68 | By the third ground of appeal, the appellant notes that, in paragraph 46 of the judgment under appeal, the General Court rejected, on the basis that it was an inadmissible new submission, his claim that the Commission’s failure to act constituted a breach of Article 41 of the Charter and of the principle of sound administration. |
| --- | --- |

68

By the third ground of appeal, the appellant notes that, in paragraph 46 of the judgment under appeal, the General Court rejected, on the basis that it was an inadmissible new submission, his claim that the Commission’s failure to act constituted a breach of Article 41 of the Charter and of the principle of sound administration.

| 69 | Yet the appellant had claimed, in his application initiating proceedings, that the obligation on the Commission to adopt a decision under Article 8(2) of Directive 93/42 arose from the principle of ‘good administration’. |
| --- | --- |

69

Yet the appellant had claimed, in his application initiating proceedings, that the obligation on the Commission to adopt a decision under Article 8(2) of Directive 93/42 arose from the principle of ‘good administration’.

| 70 | Thus, the appellant maintains that the plea alleging infringement of Article 41 of the Charter was not a new submission since the principles of ‘good administration’ and ‘sound administration’ overlap. |
| --- | --- |

70

Thus, the appellant maintains that the plea alleging infringement of Article 41 of the Charter was not a new submission since the principles of ‘good administration’ and ‘sound administration’ overlap.

| 71 | By the sixth ground of appeal, the appellant claims that, in the proceedings giving rise to the judgment under appeal, the Commission annexed to its defence submitted before the General Court, two draft decisions, one of which, entitled ‘Annex COM RENV 1’, was ready for signature and labelled ‘final’ (‘the draft decision at issue’). The appellant submits that that draft decision proves that the Commission considered the prohibition decision relating to the effecto device, adopted by the German authorities on 18 May 2005, to be unjustified. |
| --- | --- |

71

By the sixth ground of appeal, the appellant claims that, in the proceedings giving rise to the judgment under appeal, the Commission annexed to its defence submitted before the General Court, two draft decisions, one of which, entitled ‘Annex COM RENV 1’, was ready for signature and labelled ‘final’ (‘the draft decision at issue’). The appellant submits that that draft decision proves that the Commission considered the prohibition decision relating to the effecto device, adopted by the German authorities on 18 May 2005, to be unjustified.

| 72 | However, in the judgment under appeal, the General Court did not examine that piece of evidence. In order for the trial to comply with the principle of equality of arms, the General Court should have given the appellant the opportunity, at least by way of a measure of organisation of procedure, to set out his views on the draft decision at issue. Consequently, the appellant claims that the General Court infringed the right to a fair trial enshrined in Article 6 of the ECHR and Article 47 of the Charter. |
| --- | --- |

72

However, in the judgment under appeal, the General Court did not examine that piece of evidence. In order for the trial to comply with the principle of equality of arms, the General Court should have given the appellant the opportunity, at least by way of a measure of organisation of procedure, to set out his views on the draft decision at issue. Consequently, the appellant claims that the General Court infringed the right to a fair trial enshrined in Article 6 of the ECHR and Article 47 of the Charter.

| 73 | Furthermore, he submits that the fact that the General Court failed to take account of those two draft decisions produced by the Commission constitutes a distortion of the facts and evidence. He claims that those draft decisions prove that the Commission had concluded that the prohibition decision relating to the effecto device adopted by the German authorities was not proportionate. |
| --- | --- |

73

Furthermore, he submits that the fact that the General Court failed to take account of those two draft decisions produced by the Commission constitutes a distortion of the facts and evidence. He claims that those draft decisions prove that the Commission had concluded that the prohibition decision relating to the effecto device adopted by the German authorities was not proportionate.

| 74 | Lastly, by the seventh ground of appeal, the appellant claims that, in his written observations in the case giving rise to the judgment under appeal, he requested the General Court to order the Commission to produce its entire file relating to the safeguard clause procedure of 1998. |
| --- | --- |

74

Lastly, by the seventh ground of appeal, the appellant claims that, in his written observations in the case giving rise to the judgment under appeal, he requested the General Court to order the Commission to produce its entire file relating to the safeguard clause procedure of 1998.

| 75 | The appellant maintains that, by rejecting that request, the General Court infringed Article 6 of the ECHR and Article 47 of the Charter. |
| --- | --- |

75

The appellant maintains that, by rejecting that request, the General Court infringed Article 6 of the ECHR and Article 47 of the Charter.

| 76 | The Commission contends that the third, sixth and seventh grounds of appeal are unfounded. |
| --- | --- |

76

The Commission contends that the third, sixth and seventh grounds of appeal are unfounded.

Findings of the Court

Findings of the Court

| 77 | As regards the third ground of appeal, it is sufficient to note that the appellant has put forward the complaint alleging infringement of Article 41 of the Charter and of the principle of sound administration for the purposes of establishing that the conduct of the Commission was unlawful. Likewise, as regards the sixth and seventh grounds of appeal, the draft decisions produced by the Commission and ordering the Commission to produce its entire file relating to the safeguard clause procedure of 1998 would merely serve the same purpose. |
| --- | --- |

77

As regards the third ground of appeal, it is sufficient to note that the appellant has put forward the complaint alleging infringement of Article 41 of the Charter and of the principle of sound administration for the purposes of establishing that the conduct of the Commission was unlawful. Likewise, as regards the sixth and seventh grounds of appeal, the draft decisions produced by the Commission and ordering the Commission to produce its entire file relating to the safeguard clause procedure of 1998 would merely serve the same purpose.

| 78 | Yet, in paragraph 57 of the judgment under appeal, the General Court found that the Commission had committed a sufficiently serious breach of EU law. |
| --- | --- |

78

Yet, in paragraph 57 of the judgment under appeal, the General Court found that the Commission had committed a sufficiently serious breach of EU law.

| 79 | In those conditions, even if the illegalities alleged by the appellant in his third, sixth and seventh grounds of appeal were to be established, they would not justify the setting aside of the judgment under appeal since they have not produced any harmful consequences for the appellant. |
| --- | --- |

79

In those conditions, even if the illegalities alleged by the appellant in his third, sixth and seventh grounds of appeal were to be established, they would not justify the setting aside of the judgment under appeal since they have not produced any harmful consequences for the appellant.

| 80 | The third, sixth and seventh grounds of appeal must therefore be rejected as ineffective. |
| --- | --- |

80

The third, sixth and seventh grounds of appeal must therefore be rejected as ineffective.

The fourth ground of appeal

The fourth ground of appeal

Arguments of the parties

Arguments of the parties

| 81 | The appellant notes that Directive 93/42 refers not only to the ‘manufacturer’ but also to ‘the parties concerned’. Thus, he claims that that directive confers rights on the manufacturer of a medical device and on the parties concerned, such as the inventor of the device and other persons involved in its manufacture and distribution. |
| --- | --- |

81

The appellant notes that Directive 93/42 refers not only to the ‘manufacturer’ but also to ‘the parties concerned’. Thus, he claims that that directive confers rights on the manufacturer of a medical device and on the parties concerned, such as the inventor of the device and other persons involved in its manufacture and distribution.

| 82 | Consequently, given that he is the inventor of the medical device at issue, the main shareholder of atmed and the licensor in relation to Broncho-Air Medizintechnik, the appellant maintains that he has the right, on the basis of his personal situation, to rely on Article 8 of Directive 93/42 and Articles 28 et seq. TFEU. He also maintains that, compared to any other party concerned, he has been the person most affected economically by the Commission’s failure to act under Article 8 of Directive 93/42 in the context of the safeguard clause procedure of 1998. |
| --- | --- |

82

Consequently, given that he is the inventor of the medical device at issue, the main shareholder of atmed and the licensor in relation to Broncho-Air Medizintechnik, the appellant maintains that he has the right, on the basis of his personal situation, to rely on Article 8 of Directive 93/42 and Articles 28 et seq. TFEU. He also maintains that, compared to any other party concerned, he has been the person most affected economically by the Commission’s failure to act under Article 8 of Directive 93/42 in the context of the safeguard clause procedure of 1998.

| 83 | Likewise, he submits that that article confers rights on atmed, the manufacturer of the effecto device, which is also a concerned party in relation to the safeguard clause procedure of 1998. In addition, since the Inhaler and effecto devices are identical, they should comply with the same conditions as regards Directive 93/42. |
| --- | --- |

83

Likewise, he submits that that article confers rights on atmed, the manufacturer of the effecto device, which is also a concerned party in relation to the safeguard clause procedure of 1998. In addition, since the Inhaler and effecto devices are identical, they should comply with the same conditions as regards Directive 93/42.

| 84 | Furthermore, he asserts that an annex to the application initiating proceedings establishes that the Commission’s letter of 22 February 2007 was also addressed to atmed. In that letter the Commission proposed to the German authorities to assess the prohibition decision relating to the effecto device in the context of the safeguard clause procedure of 1998 concerning the Inhaler device. Thus, the General Court based its view on incorrect facts and committed a manifest error of assessment in assuming that atmed was not concerned by the safeguard clause procedure. |
| --- | --- |

84

Furthermore, he asserts that an annex to the application initiating proceedings establishes that the Commission’s letter of 22 February 2007 was also addressed to atmed. In that letter the Commission proposed to the German authorities to assess the prohibition decision relating to the effecto device in the context of the safeguard clause procedure of 1998 concerning the Inhaler device. Thus, the General Court based its view on incorrect facts and committed a manifest error of assessment in assuming that atmed was not concerned by the safeguard clause procedure.

| 85 | In the view of the appellant, it follows from those considerations that the General Court was wrong to hold that he does not have the right to claim compensation in relation to the effecto device, either in a personal capacity or on behalf of atmed. |
| --- | --- |

85

In the view of the appellant, it follows from those considerations that the General Court was wrong to hold that he does not have the right to claim compensation in relation to the effecto device, either in a personal capacity or on behalf of atmed.

| 86 | The Commission contends that the Court of Justice should reject the fourth ground of appeal as unfounded. |
| --- | --- |

86

The Commission contends that the Court of Justice should reject the fourth ground of appeal as unfounded.

Findings of the Court

Findings of the Court

| 87 | In the present case, the appellant has brought an action for a declaration of non-contractual liability seeking compensation for the infringement of his personal rights and of the rights of both Broncho-Air Medizintechnik and atmed, since those companies have transferred their rights to compensation to him. |
| --- | --- |

87

In the present case, the appellant has brought an action for a declaration of non-contractual liability seeking compensation for the infringement of his personal rights and of the rights of both Broncho-Air Medizintechnik and atmed, since those companies have transferred their rights to compensation to him.

| 88 | By the present ground of appeal, the appellant alleges that the General Court erred in holding, in paragraphs 63 to 67 of the judgment under appeal, that he could rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik by means of a transfer agreement concluded between that company and the appellant on 27 January 2007, and could not rely on rights to compensation associated with his personal situation or atmed, which had been the exclusive distributor of the effecto device and later also assumed responsibility for its manufacture. |
| --- | --- |

88

By the present ground of appeal, the appellant alleges that the General Court erred in holding, in paragraphs 63 to 67 of the judgment under appeal, that he could rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik by means of a transfer agreement concluded between that company and the appellant on 27 January 2007, and could not rely on rights to compensation associated with his personal situation or atmed, which had been the exclusive distributor of the effecto device and later also assumed responsibility for its manufacture.

| 89 | First, as is apparent from the examination of the first ground of appeal raised by the appellant in the present case, the General Court, in the judgment under appeal, was right to reject as inadmissible the second head of claim raised before it, requesting that the Commission also be ordered to pay the appellant compensation on account of that institution’s failure to act in relation to the effecto device. |
| --- | --- |

89

First, as is apparent from the examination of the first ground of appeal raised by the appellant in the present case, the General Court, in the judgment under appeal, was right to reject as inadmissible the second head of claim raised before it, requesting that the Commission also be ordered to pay the appellant compensation on account of that institution’s failure to act in relation to the effecto device.

| 90 | In those circumstances, given that atmed had only distributed and later manufactured the effecto device, the General Court was correct to hold that the appellant could not rely on the rights to compensation that had been transferred to him by that company. |
| --- | --- |

90

In those circumstances, given that atmed had only distributed and later manufactured the effecto device, the General Court was correct to hold that the appellant could not rely on the rights to compensation that had been transferred to him by that company.

| 91 | In that regard, the fact that the letter of 22 February 2007, in which the Commission proposed to the German authorities to assess the prohibition decision of 18 May 2005 in the context of the safeguard clause procedure of 1998 and handle it on the basis of the new information, was also addressed to atmed does not entitle the appellant to claim compensation in relation to the Inhaler device in the context of the application of Article 8 of Directive 93/42. |
| --- | --- |

91

In that regard, the fact that the letter of 22 February 2007, in which the Commission proposed to the German authorities to assess the prohibition decision of 18 May 2005 in the context of the safeguard clause procedure of 1998 and handle it on the basis of the new information, was also addressed to atmed does not entitle the appellant to claim compensation in relation to the Inhaler device in the context of the application of Article 8 of Directive 93/42.

| 92 | Secondly, as regards the rights to compensation claimed by the appellant on the basis of his personal situation, it is true that the introductory part of Article 8(2) of Directive 93/42 makes reference to the ‘parties concerned’. Nevertheless, the second indent of that provision specifies that where the measures are unjustified, the Commission is to immediately so inform the Member State which took the initiative and the ‘manufacturer’ or his authorised representative established within the European Union. No other concerned party is mentioned in that provision. |
| --- | --- |

92

Secondly, as regards the rights to compensation claimed by the appellant on the basis of his personal situation, it is true that the introductory part of Article 8(2) of Directive 93/42 makes reference to the ‘parties concerned’. Nevertheless, the second indent of that provision specifies that where the measures are unjustified, the Commission is to immediately so inform the Member State which took the initiative and the ‘manufacturer’ or his authorised representative established within the European Union. No other concerned party is mentioned in that provision.

| 93 | Thus, it is clear from the very wording of the second indent of Article 8(2) of Directive 93/42 that rights to compensation may be conferred only on the manufacturer of the medical device or his authorised representative. |
| --- | --- |

93

Thus, it is clear from the very wording of the second indent of Article 8(2) of Directive 93/42 that rights to compensation may be conferred only on the manufacturer of the medical device or his authorised representative.

| 94 | Consequently, the General Court rightly held that the appellant could not rely on rights to compensation associated with his personal situation. |
| --- | --- |

94

Consequently, the General Court rightly held that the appellant could not rely on rights to compensation associated with his personal situation.

| 95 | Furthermore, in relation to the appellant’s claim that Articles 28 et seq. TFEU conferred on him, in his personal capacity, and on atmed rights to compensation under Article 8 of Directive 93/42, it is sufficient to note that such an argument was not put forward in his application initiating proceedings. It therefore constitutes a new plea and is, accordingly, inadmissible. |
| --- | --- |

95

Furthermore, in relation to the appellant’s claim that Articles 28 et seq. TFEU conferred on him, in his personal capacity, and on atmed rights to compensation under Article 8 of Directive 93/42, it is sufficient to note that such an argument was not put forward in his application initiating proceedings. It therefore constitutes a new plea and is, accordingly, inadmissible.

| 96 | Consequently, the fourth ground of appeal must be rejected. |
| --- | --- |

96

Consequently, the fourth ground of appeal must be rejected.

The fifth ground of appeal

The fifth ground of appeal

Arguments of the parties

Arguments of the parties

| 97 | The appellant notes that the General Court, in paragraphs 74 and 75 of the judgment under appeal, found that Broncho-Air Medizintechnik and Primed Halberstadt had voluntarily ceased placing the Inhaler device on the market, on the ground that Broncho-Air Medizintechnik had stated in its letter of 22 May 1997 that it would no longer market the device for the time being. |
| --- | --- |

97

The appellant notes that the General Court, in paragraphs 74 and 75 of the judgment under appeal, found that Broncho-Air Medizintechnik and Primed Halberstadt had voluntarily ceased placing the Inhaler device on the market, on the ground that Broncho-Air Medizintechnik had stated in its letter of 22 May 1997 that it would no longer market the device for the time being.

| 98 | Nevertheless, the appellant claims that the cessation of the marketing of the Inhaler device was not a voluntary act on the part of Broncho-Air Medizintechnik, whose objective was to place the device on the market, but the German authorities left it no other choice since in practice no one would buy a product which, even if not objectively dangerous, was the subject of a pending prohibition procedure. In addition, in accordance with civil law, the appellant would have been under an obligation to disclose such information to potential purchasers, which would have dissuaded them from buying the Inhaler device. |
| --- | --- |

98

Nevertheless, the appellant claims that the cessation of the marketing of the Inhaler device was not a voluntary act on the part of Broncho-Air Medizintechnik, whose objective was to place the device on the market, but the German authorities left it no other choice since in practice no one would buy a product which, even if not objectively dangerous, was the subject of a pending prohibition procedure. In addition, in accordance with civil law, the appellant would have been under an obligation to disclose such information to potential purchasers, which would have dissuaded them from buying the Inhaler device.

| 99 | Thus, the appellant claims that the General Court distorted the facts in paragraphs 74 and 75 of the judgment under appeal since that Court’s own findings of fact indicated that Broncho-Air Medizintechnik had not voluntarily withdrawn its device from the market. |
| --- | --- |

99

Thus, the appellant claims that the General Court distorted the facts in paragraphs 74 and 75 of the judgment under appeal since that Court’s own findings of fact indicated that Broncho-Air Medizintechnik had not voluntarily withdrawn its device from the market.

| 100 | The fact that the German authorities decided, on 23 September 1997, to prohibit the placing on the market of the Inhaler device, also indicates that that withdrawal was not voluntary, since such a decision would not have been necessary if Broncho-Air Medizintechnik and Primed Halberstadt had voluntarily withdrawn the device from the market. |
| --- | --- |

100

The fact that the German authorities decided, on 23 September 1997, to prohibit the placing on the market of the Inhaler device, also indicates that that withdrawal was not voluntary, since such a decision would not have been necessary if Broncho-Air Medizintechnik and Primed Halberstadt had voluntarily withdrawn the device from the market.

| 101 | Furthermore, Primed Halberstadt, with the agreement of Broncho-Air Medizintechnik, brought an action against the prohibition decision of 23 September 1997, which it would not have done if the Inhaler device had been withdrawn from the market voluntarily. Thus, that prohibition decision and the action brought against it rendered redundant the statement made in the letter of 22 May 1997. |
| --- | --- |

101

Furthermore, Primed Halberstadt, with the agreement of Broncho-Air Medizintechnik, brought an action against the prohibition decision of 23 September 1997, which it would not have done if the Inhaler device had been withdrawn from the market voluntarily. Thus, that prohibition decision and the action brought against it rendered redundant the statement made in the letter of 22 May 1997.

| 102 | Moreover, the considerations set out in paragraphs 74 and 75 of the judgment under appeal are based on an incorrect legal characterisation of the facts since, if the Commission, following notification by means of the letter of 7 January 1998, had adopted without delay a decision under Article 8 of Directive 93/42, Broncho-Air Medizintechnik would immediately have been able to sell the Inhaler device again. Thus, the appellant claims that it was the Commission’s failure to act which gave rise to the damage subsequently sustained, in particular, the costs related to the formation of atmed and the conformity assessment of the effecto device, rather than the initial decision to suspend the placing on the market of the Inhaler device. |
| --- | --- |

102

Moreover, the considerations set out in paragraphs 74 and 75 of the judgment under appeal are based on an incorrect legal characterisation of the facts since, if the Commission, following notification by means of the letter of 7 January 1998, had adopted without delay a decision under Article 8 of Directive 93/42, Broncho-Air Medizintechnik would immediately have been able to sell the Inhaler device again. Thus, the appellant claims that it was the Commission’s failure to act which gave rise to the damage subsequently sustained, in particular, the costs related to the formation of atmed and the conformity assessment of the effecto device, rather than the initial decision to suspend the placing on the market of the Inhaler device.

| 103 | The appellant also submits that the General Court, in paragraph 76 of the judgment under appeal, erred in its legal characterisation of atmed’s email of 18 December 2006. That company could not make a declaration on behalf of Broncho-Air Medizintechnik and that document is not capable of contradicting the fact that, from the date on which the Commission should have adopted a decision, its failure to act was the determinant cause of the device not being distributed. |
| --- | --- |

103

The appellant also submits that the General Court, in paragraph 76 of the judgment under appeal, erred in its legal characterisation of atmed’s email of 18 December 2006. That company could not make a declaration on behalf of Broncho-Air Medizintechnik and that document is not capable of contradicting the fact that, from the date on which the Commission should have adopted a decision, its failure to act was the determinant cause of the device not being distributed.

| 104 | The appellant notes that, in paragraphs 79 and 80 of the judgment under appeal, the General Court concluded that there was no causal link between the Commission’s conduct and the alleged damage since it was not certain that the Commission would have adopted a decision favourable to the appellant. However, the General Court referred only to the information provided by the German authorities, without carrying out its own examination, which constitutes a failure to state reasons. As part of that examination, the General Court ought to have concluded that the Commission was required to take account, inter alia, of the fact that the Inhaler device bore the CE marking, of the principle of proportionality in the light of the fact that the device in question was a Class I medical device presenting, in principle, a very low risk to human health, and of the case-law of the Court of Justice relating to the provisions of Directive 93/42. On that basis, the General Court ought to have found that the prohibition decision of 23 September 1997, adopted by the German authorities in relation to the Inhaler device, was not justified. |
| --- | --- |

104

The appellant notes that, in paragraphs 79 and 80 of the judgment under appeal, the General Court concluded that there was no causal link between the Commission’s conduct and the alleged damage since it was not certain that the Commission would have adopted a decision favourable to the appellant. However, the General Court referred only to the information provided by the German authorities, without carrying out its own examination, which constitutes a failure to state reasons. As part of that examination, the General Court ought to have concluded that the Commission was required to take account, inter alia, of the fact that the Inhaler device bore the CE marking, of the principle of proportionality in the light of the fact that the device in question was a Class I medical device presenting, in principle, a very low risk to human health, and of the case-law of the Court of Justice relating to the provisions of Directive 93/42. On that basis, the General Court ought to have found that the prohibition decision of 23 September 1997, adopted by the German authorities in relation to the Inhaler device, was not justified.

| 105 | The appellant disputes that his assertions in relation to the outcome of the safeguard clause procedure are ‘hypothetical’, as found in paragraph 81 of the judgment under appeal. His arguments are based on a legal and factual examination such as should have been carried out by the Commission. Furthermore, the General Court should have taken account of the draft decision at issue according to which the prohibition decision relating to the effecto device adopted by the German authorities was not justified. |
| --- | --- |

105

The appellant disputes that his assertions in relation to the outcome of the safeguard clause procedure are ‘hypothetical’, as found in paragraph 81 of the judgment under appeal. His arguments are based on a legal and factual examination such as should have been carried out by the Commission. Furthermore, the General Court should have taken account of the draft decision at issue according to which the prohibition decision relating to the effecto device adopted by the German authorities was not justified.

| 106 | The appellant maintains that the General Court, following its rejection of his second head of claim, relating to the effecto device, failed to take that device into consideration any further, which amounts to an incorrect legal characterisation of the facts. If, after initiation of the safeguard clause procedure of 1998, the Commission had adopted a decision, Broncho-Air Medizintechnik would, following that decision, have been able to market and sell the Inhaler device to this day. In any event, the consequences resulting from the absence of a Commission decision were sufficiently direct, since that absence was the principal, decisive and objectively foreseeable cause of the costs incurred in connection with the formation, and later the dissolution, of atmed. |
| --- | --- |

106

The appellant maintains that the General Court, following its rejection of his second head of claim, relating to the effecto device, failed to take that device into consideration any further, which amounts to an incorrect legal characterisation of the facts. If, after initiation of the safeguard clause procedure of 1998, the Commission had adopted a decision, Broncho-Air Medizintechnik would, following that decision, have been able to market and sell the Inhaler device to this day. In any event, the consequences resulting from the absence of a Commission decision were sufficiently direct, since that absence was the principal, decisive and objectively foreseeable cause of the costs incurred in connection with the formation, and later the dissolution, of atmed.

| 107 | Lastly, the appellant claims that it would not have been necessary to incur the costs and lawyers’ fees or the loans and interest payments undertaken to finance the proceedings brought before the national courts, if the Commission had adopted, within a reasonable period of time, a decision in the context of the safeguard clause procedure of 1998 under Article 8 of Directive 93/42. |
| --- | --- |

107

Lastly, the appellant claims that it would not have been necessary to incur the costs and lawyers’ fees or the loans and interest payments undertaken to finance the proceedings brought before the national courts, if the Commission had adopted, within a reasonable period of time, a decision in the context of the safeguard clause procedure of 1998 under Article 8 of Directive 93/42.

| 108 | The Commission contends that there is no ground for the assertion that its failure to act forced Broncho-Air Medizintechnik to cease distribution of the Inhaler device in 1997. It is inconceivable, not least from a chronological perspective, that Broncho-Air Medizintechnik’s decision to cease the placing on the market of that device from 1 January 1997 was an inevitable consequence of the fact that the Commission did not react following notification by means of the letter of 7 January 1998. |
| --- | --- |

108

The Commission contends that there is no ground for the assertion that its failure to act forced Broncho-Air Medizintechnik to cease distribution of the Inhaler device in 1997. It is inconceivable, not least from a chronological perspective, that Broncho-Air Medizintechnik’s decision to cease the placing on the market of that device from 1 January 1997 was an inevitable consequence of the fact that the Commission did not react following notification by means of the letter of 7 January 1998.

| 109 | If Broncho-Air Medizintechnik considered that the placing on the market of the Inhaler device was lawful, it could have continued to distribute that device and brought an action against a future prohibition decision, as provided for in the German Code of Administrative Procedure, which, in principle, would have had a suspensory effect. Primed Halberstadt Medizintechnik initiated such an action against the prohibition decision of 23 September 1997, adopted by the German authorities in relation to the Inhaler device, and that decision never became final on account of the suspensory effect of that action. Thus, in the Commission’s view, and contrary to the claims of the appellant, the formation of atmed was not indispensable. |
| --- | --- |

109

If Broncho-Air Medizintechnik considered that the placing on the market of the Inhaler device was lawful, it could have continued to distribute that device and brought an action against a future prohibition decision, as provided for in the German Code of Administrative Procedure, which, in principle, would have had a suspensory effect. Primed Halberstadt Medizintechnik initiated such an action against the prohibition decision of 23 September 1997, adopted by the German authorities in relation to the Inhaler device, and that decision never became final on account of the suspensory effect of that action. Thus, in the Commission’s view, and contrary to the claims of the appellant, the formation of atmed was not indispensable.

| 110 | The fact that the Inhaler device could still have been marketed is confirmed by the fact that, according to the assertions of the appellant himself in the case which gave rise to the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), that device was manufactured by Primed Halberstadt Medizintechnik between 1996 and 2001 and continued to be marketed by Broncho-Air Medizintechnik between 1996 and 2002. |
| --- | --- |

110

The fact that the Inhaler device could still have been marketed is confirmed by the fact that, according to the assertions of the appellant himself in the case which gave rise to the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19), that device was manufactured by Primed Halberstadt Medizintechnik between 1996 and 2001 and continued to be marketed by Broncho-Air Medizintechnik between 1996 and 2002.

| 111 | The Commission contends that the ground of appeal alleging distortion of the facts has not been sufficiently substantiated and that the General Court did not hold, in paragraph 75 of the judgment under appeal, that the safeguard clause procedure of 1998 had become devoid of purpose. Furthermore, atmed’s email of 18 December 2006 corroborates the finding that Broncho-Air Medizintechnik decided on its own initiative to cease the placing on the market of the Inhaler device. |
| --- | --- |

111

The Commission contends that the ground of appeal alleging distortion of the facts has not been sufficiently substantiated and that the General Court did not hold, in paragraph 75 of the judgment under appeal, that the safeguard clause procedure of 1998 had become devoid of purpose. Furthermore, atmed’s email of 18 December 2006 corroborates the finding that Broncho-Air Medizintechnik decided on its own initiative to cease the placing on the market of the Inhaler device.

| 112 | As regards the presumed outcome of the Commission decision following notification by means of the letter of 7 January 1998, the Commission contends that the damage allegedly sustained by the appellant would be imputable to unlawful conduct on its part only if it could be established that that damage would not have arisen if the Commission’s conduct had not been unlawful. Yet, in paragraph 79 of the judgment under appeal, the General Court noted that Broncho-Air Medizintechnik itself had acknowledged that additional scientific studies and trials were needed in order to assess the safety of the Inhaler device. |
| --- | --- |

112

As regards the presumed outcome of the Commission decision following notification by means of the letter of 7 January 1998, the Commission contends that the damage allegedly sustained by the appellant would be imputable to unlawful conduct on its part only if it could be established that that damage would not have arisen if the Commission’s conduct had not been unlawful. Yet, in paragraph 79 of the judgment under appeal, the General Court noted that Broncho-Air Medizintechnik itself had acknowledged that additional scientific studies and trials were needed in order to assess the safety of the Inhaler device.

| 113 | As regards the argument alleging breach of the obligation to state reasons, the General Court, in paragraph 72 of the judgment under appeal, correctly relied on the content of the prohibition decision of 23 September 1997 and of the letter of 7 January 1998 in concluding that it was not certain that the Commission would have adopted a decision to the effect alleged by the appellant. |
| --- | --- |

113

As regards the argument alleging breach of the obligation to state reasons, the General Court, in paragraph 72 of the judgment under appeal, correctly relied on the content of the prohibition decision of 23 September 1997 and of the letter of 7 January 1998 in concluding that it was not certain that the Commission would have adopted a decision to the effect alleged by the appellant.

| 114 | In addition, the Federal Republic of Germany produced the evidence required under Article 8 of Directive 93/42 in the event of risks linked to medical devices and the decision of the German authorities decision ought, in any event, to have been upheld on account of the uncertainties concerning the effectiveness of the Inhaler device and the lack of clinical data. |
| --- | --- |

114

In addition, the Federal Republic of Germany produced the evidence required under Article 8 of Directive 93/42 in the event of risks linked to medical devices and the decision of the German authorities decision ought, in any event, to have been upheld on account of the uncertainties concerning the effectiveness of the Inhaler device and the lack of clinical data.

| 115 | The Commission submits that the appellant’s arguments in connection with the outcome of the safeguard clause procedure of 1998 are not substantiated. For the sake of completeness, it states that, before the General Court, the appellant relied on the draft decision at issue in the context of establishing that the Commission had committed a sufficiently serious breach of a rule of law, not in the context of the assessment of the existence of a causal link between the Commission’s conduct and the alleged damage. Moreover, that draft decision is not capable of establishing the existence of such a causal link. |
| --- | --- |

115

The Commission submits that the appellant’s arguments in connection with the outcome of the safeguard clause procedure of 1998 are not substantiated. For the sake of completeness, it states that, before the General Court, the appellant relied on the draft decision at issue in the context of establishing that the Commission had committed a sufficiently serious breach of a rule of law, not in the context of the assessment of the existence of a causal link between the Commission’s conduct and the alleged damage. Moreover, that draft decision is not capable of establishing the existence of such a causal link.

| 116 | As regards the argument concerning the causal link in relation to the effecto device, the Commission contends, first, that the General Court was not bound to respond to it since neither the appellant, in his personal capacity, nor atmed come within the scope of Article 8 of Directive 93/42. Secondly, the appellant was not obliged to bear the costs arising from the formation of atmed. |
| --- | --- |

116

As regards the argument concerning the causal link in relation to the effecto device, the Commission contends, first, that the General Court was not bound to respond to it since neither the appellant, in his personal capacity, nor atmed come within the scope of Article 8 of Directive 93/42. Secondly, the appellant was not obliged to bear the costs arising from the formation of atmed.

| 117 | As regards the legal costs incurred by the appellant in connection with the proceedings before the national courts, the Commission maintains that they are not attributable in a sufficiently direct manner to the conduct of the Commission. Moreover, they are in no way linked to the Commission’s failure to act following receipt of the letter of 7 January 1998. |
| --- | --- |

117

As regards the legal costs incurred by the appellant in connection with the proceedings before the national courts, the Commission maintains that they are not attributable in a sufficiently direct manner to the conduct of the Commission. Moreover, they are in no way linked to the Commission’s failure to act following receipt of the letter of 7 January 1998.

| 118 | In conclusion, the Commission contends that the fifth ground of appeal is entirely unfounded. |
| --- | --- |

118

In conclusion, the Commission contends that the fifth ground of appeal is entirely unfounded.

Findings of the Court

Findings of the Court

| 119 | In the present case, after finding that the Commission had committed a sufficiently serious breach of EU law and that the appellant could rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik, the General Court found, in paragraph 73 of the judgment under appeal, that there was no causal link between the Commission’s unlawful conduct and the damage alleged by the appellant. |
| --- | --- |

119

In the present case, after finding that the Commission had committed a sufficiently serious breach of EU law and that the appellant could rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik, the General Court found, in paragraph 73 of the judgment under appeal, that there was no causal link between the Commission’s unlawful conduct and the damage alleged by the appellant.

| 120 | In that regard, in the first place, the General Court pointed out, in paragraph 74 of the judgment under appeal, that Broncho-Air Medizintechnik had informed the German authorities, in the letter of 22 May 1997, of its intention to voluntarily cease the sale of the Inhaler device until further trials and studies on the conformity of that device with Directive 93/42 became available. |
| --- | --- |

120

In that regard, in the first place, the General Court pointed out, in paragraph 74 of the judgment under appeal, that Broncho-Air Medizintechnik had informed the German authorities, in the letter of 22 May 1997, of its intention to voluntarily cease the sale of the Inhaler device until further trials and studies on the conformity of that device with Directive 93/42 became available.

| 121 | In paragraph 75 of the judgment under appeal, the General Court concluded that cessation of placing on the market and selling of the Inhaler device took place before the adoption, on 23 September 1997, of the decision prohibiting marketing of that device and before the Commission was informed of that decision in accordance with Article 8(1) of Directive 93/42, on 7 January 1998. Furthermore, the damage alleged by the appellant, which inter alia consisted, according to him, in loss of sales of the Inhaler device and other claims arising from that loss of sales, therefore resulted from the decision taken by Broncho-Air Medizintechnik on its own initiative, and not from the Commission’s alleged failure to act. |
| --- | --- |

121

In paragraph 75 of the judgment under appeal, the General Court concluded that cessation of placing on the market and selling of the Inhaler device took place before the adoption, on 23 September 1997, of the decision prohibiting marketing of that device and before the Commission was informed of that decision in accordance with Article 8(1) of Directive 93/42, on 7 January 1998. Furthermore, the damage alleged by the appellant, which inter alia consisted, according to him, in loss of sales of the Inhaler device and other claims arising from that loss of sales, therefore resulted from the decision taken by Broncho-Air Medizintechnik on its own initiative, and not from the Commission’s alleged failure to act.

| 122 | The General Court added, in paragraph 76 of the judgment under appeal, that, even though the appellant claimed that the Inhaler device had not been distributed from 1997 onwards on account of the prohibition decision of 23 September 1997 and the Commission’s failure to act, it was clear that such an argument was contradicted by atmed’s statements in the email it sent to the Commission on 18 December 2006, which confirmed that cessation of distribution of the Inhaler device was voluntary. |
| --- | --- |

122

The General Court added, in paragraph 76 of the judgment under appeal, that, even though the appellant claimed that the Inhaler device had not been distributed from 1997 onwards on account of the prohibition decision of 23 September 1997 and the Commission’s failure to act, it was clear that such an argument was contradicted by atmed’s statements in the email it sent to the Commission on 18 December 2006, which confirmed that cessation of distribution of the Inhaler device was voluntary.

| 123 | The appellant claims that the General Court distorted the facts in coming to such conclusions since it is apparent from the documents in the file that there is a causal link between the Commission’s unlawful conduct and the damage he claims to have suffered as a result. |
| --- | --- |

123

The appellant claims that the General Court distorted the facts in coming to such conclusions since it is apparent from the documents in the file that there is a causal link between the Commission’s unlawful conduct and the damage he claims to have suffered as a result.

| 124 | It follows from the second subparagraph of Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that the General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy of its findings is apparent from the documents submitted to it, and, second, to assess those facts (judgments of 6 April 2006, General Motors v Commission, C‐551/03 P, EU:C:2006:229, paragraph 51, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 30). |
| --- | --- |

124

It follows from the second subparagraph of Article 256(1) TFEU and the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union that the General Court has exclusive jurisdiction, first, to find the facts, except where the substantive inaccuracy of its findings is apparent from the documents submitted to it, and, second, to assess those facts (judgments of 6 April 2006, General Motors v Commission, C‐551/03 P, EU:C:2006:229, paragraph 51, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 30).

| 125 | Therefore, the appraisal of the facts by the General Court does not constitute, save where the clear sense of the evidence produced before it is distorted, a question of law which is subject, as such, to review by the Court of Justice (judgments of 18 May 2006, Archer Daniels Midland and Archer Daniels Midland Ingredients v Commission, C‐397/03 P, EU:C:2006:328, paragraph 85, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 31). |
| --- | --- |

125

Therefore, the appraisal of the facts by the General Court does not constitute, save where the clear sense of the evidence produced before it is distorted, a question of law which is subject, as such, to review by the Court of Justice (judgments of 18 May 2006, Archer Daniels Midland and Archer Daniels Midland Ingredients v Commission, C‐397/03 P, EU:C:2006:328, paragraph 85, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 31).

| 126 | Where an appellant alleges distortion of the evidence by the General Court, he must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of the Rules of Procedure of the Court of Justice, indicate precisely the evidence alleged to have been distorted by the General Court and show the errors of appraisal which, in its view, led to such distortion. In addition, the Court of Justice has consistently held that that distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence (judgments of 17 June 2010, Lafarge v Commission, C‐413/08 P, EU:C:2010:346, paragraph 16, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 32). |
| --- | --- |

126

Where an appellant alleges distortion of the evidence by the General Court, he must, under Article 256 TFEU, the first paragraph of Article 58 of the Statute of the Court of Justice of the European Union and Article 168(1)(d) of the Rules of Procedure of the Court of Justice, indicate precisely the evidence alleged to have been distorted by the General Court and show the errors of appraisal which, in its view, led to such distortion. In addition, the Court of Justice has consistently held that that distortion must be obvious from the documents in the Court’s file, without there being any need to carry out a new assessment of the facts and the evidence (judgments of 17 June 2010, Lafarge v Commission, C‐413/08 P, EU:C:2010:346, paragraph 16, and of 8 March 2016, Greece v Commission, C‐431/14 P, EU:C:2016:145, paragraph 32).

| 127 | It is apparent from the file submitted to the Court of Justice that, in 1996, the German authorities sent Broncho-Air Medizintechnik a draft decision to prohibit the distribution of the Inhaler device. In the letter of 22 May 1997, Broncho-Air Medizintechnik informed the German authorities that that device had not been placed on the market since 1 January 1997 and that its distribution would remain suspended until further trials and studies on the conformity of the product with Directive 93/42 were available. On 23 September 1997, the German authorities adopted a decision prohibiting Primed Halberstadt Medizintechnik, which produced the Inhaler device on behalf of Broncho-Air Medizintechnik, from placing the device on the market. |
| --- | --- |

127

It is apparent from the file submitted to the Court of Justice that, in 1996, the German authorities sent Broncho-Air Medizintechnik a draft decision to prohibit the distribution of the Inhaler device. In the letter of 22 May 1997, Broncho-Air Medizintechnik informed the German authorities that that device had not been placed on the market since 1 January 1997 and that its distribution would remain suspended until further trials and studies on the conformity of the product with Directive 93/42 were available. On 23 September 1997, the German authorities adopted a decision prohibiting Primed Halberstadt Medizintechnik, which produced the Inhaler device on behalf of Broncho-Air Medizintechnik, from placing the device on the market.

| 128 | In that regard, it must, in any event, be observed that that prohibition decision brought to an end the voluntary nature of the cessation of marketing of the Inhaler device on the part of Broncho-Air Medizintechnik. |
| --- | --- |

128

In that regard, it must, in any event, be observed that that prohibition decision brought to an end the voluntary nature of the cessation of marketing of the Inhaler device on the part of Broncho-Air Medizintechnik.

| 129 | In addition, as stated by the appellant in his application initiating proceedings, without being challenged in that respect by the Commission, Primed Halberstadt Medizintechnik brought an action against the prohibition decision of 23 September 1997 before the German courts, pursuant to the German Code of Administrative Procedure. |
| --- | --- |

129

In addition, as stated by the appellant in his application initiating proceedings, without being challenged in that respect by the Commission, Primed Halberstadt Medizintechnik brought an action against the prohibition decision of 23 September 1997 before the German courts, pursuant to the German Code of Administrative Procedure.

| 130 | Thus, that action, even if it had suspensory effect, confirms that cessation of marketing of the Inhaler device on the part of Broncho-Air Medizintechnik was not, in the present case, voluntary. |
| --- | --- |

130

Thus, that action, even if it had suspensory effect, confirms that cessation of marketing of the Inhaler device on the part of Broncho-Air Medizintechnik was not, in the present case, voluntary.

| 131 | Moreover, contrary to the findings of the General Court in paragraph 76 of the judgment under appeal, the content of atmed’s email of 18 December 2006 is not capable of confirming the voluntary nature of the cessation of marketing of the Inhaler device by Broncho-Air Medizintechnik. First, that mere statement made by atmed a number of years after the facts at issue and which was not made on behalf of Broncho-Air Medizintechnik, cannot be binding on the latter. Secondly, as has already been observed, the action brought against the prohibition decision of 23 September 1997 confirms, in itself, that the cessation of marketing of the Inhaler device was not voluntary. |
| --- | --- |

131

Moreover, contrary to the findings of the General Court in paragraph 76 of the judgment under appeal, the content of atmed’s email of 18 December 2006 is not capable of confirming the voluntary nature of the cessation of marketing of the Inhaler device by Broncho-Air Medizintechnik. First, that mere statement made by atmed a number of years after the facts at issue and which was not made on behalf of Broncho-Air Medizintechnik, cannot be binding on the latter. Secondly, as has already been observed, the action brought against the prohibition decision of 23 September 1997 confirms, in itself, that the cessation of marketing of the Inhaler device was not voluntary.

| 132 | Consequently, in so far as it found that, in the present case, Broncho-Air Medizintechnik had voluntarily ceased marketing the Inhaler device, the General Court distorted the facts submitted for its assessment and thus vitiated the judgment under appeal. |
| --- | --- |

132

Consequently, in so far as it found that, in the present case, Broncho-Air Medizintechnik had voluntarily ceased marketing the Inhaler device, the General Court distorted the facts submitted for its assessment and thus vitiated the judgment under appeal.

| 133 | It follows that the General Court could not reasonably conclude, on the basis of that finding, that there was no causal link between the Commission’s conduct and the damage alleged by the appellant. |
| --- | --- |

133

It follows that the General Court could not reasonably conclude, on the basis of that finding, that there was no causal link between the Commission’s conduct and the damage alleged by the appellant.

| 134 | Having found that the appellant had not established the existence of such a causal link, the General Court, found, in the second place, in paragraphs 77 to 81 of the judgment under appeal, that the argument to the effect that the Commission would, in any event, have adopted a decision contrary to the finding of the German authorities could not be upheld. |
| --- | --- |

134

Having found that the appellant had not established the existence of such a causal link, the General Court, found, in the second place, in paragraphs 77 to 81 of the judgment under appeal, that the argument to the effect that the Commission would, in any event, have adopted a decision contrary to the finding of the German authorities could not be upheld.

| 135 | As the Advocate General observed in point 72 of his Opinion, the question regarding the alleged definiteness of the Commission decision should, in the present instance, have been examined by the General Court as part of its assessment as to whether actual damage had been established and the extent of that damage, in connection to the Inhaler device, not as part of its assessment as to whether there was a causal link between the Commission’s conduct and the alleged damage. |
| --- | --- |

135

As the Advocate General observed in point 72 of his Opinion, the question regarding the alleged definiteness of the Commission decision should, in the present instance, have been examined by the General Court as part of its assessment as to whether actual damage had been established and the extent of that damage, in connection to the Inhaler device, not as part of its assessment as to whether there was a causal link between the Commission’s conduct and the alleged damage.

| 136 | Accordingly, the General Court committed an error of law in finding that no such link had been established on the ground that it was not certain that the Commission would have adopted a decision favourable to the appellant following the notification of the German authorities in the letter of 7 January 1998. |
| --- | --- |

136

Accordingly, the General Court committed an error of law in finding that no such link had been established on the ground that it was not certain that the Commission would have adopted a decision favourable to the appellant following the notification of the German authorities in the letter of 7 January 1998.

| 137 | Lastly, the General Court held, in the third place, in paragraph 82 of the judgment under appeal, that the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts were incurred on his own initiative for the purpose of challenging the legality of the decisions of the German authorities and thus not imputable to the Commission. |
| --- | --- |

137

Lastly, the General Court held, in the third place, in paragraph 82 of the judgment under appeal, that the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts were incurred on his own initiative for the purpose of challenging the legality of the decisions of the German authorities and thus not imputable to the Commission.

| 138 | However, as argued by the appellant, the General Court erred in rejecting the existence of a link between those expenses, in particular as regards the costs incurred in connection with the action against the prohibition decision of 23 September 1997 and the fact that the Commission did not adopt a decision on the basis of Article 8(2) of Directive 93/42 in relation to the Inhaler device. Those expenses were incurred and, at the very least, have continued to be incurred due to the fact that the Commission did not adopt a decision. |
| --- | --- |

138

However, as argued by the appellant, the General Court erred in rejecting the existence of a link between those expenses, in particular as regards the costs incurred in connection with the action against the prohibition decision of 23 September 1997 and the fact that the Commission did not adopt a decision on the basis of Article 8(2) of Directive 93/42 in relation to the Inhaler device. Those expenses were incurred and, at the very least, have continued to be incurred due to the fact that the Commission did not adopt a decision.

| 139 | Consequently, it must be held that the General Court erred in law in rejecting the existence of a causal link between the Commission’s unlawful conduct and the damage alleged by the appellant, as regards the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts. |
| --- | --- |

139

Consequently, it must be held that the General Court erred in law in rejecting the existence of a causal link between the Commission’s unlawful conduct and the damage alleged by the appellant, as regards the costs and lawyers’ fees as well as the loans and interest payments undertaken by the appellant in order to finance the proceedings brought before the national courts.

| 140 | In the light of the foregoing considerations, the fifth ground of appeal must be upheld and, accordingly, the judgment under appeal must be set aside in so far as the General Court dismissed the action on the ground that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability. |
| --- | --- |

140

In the light of the foregoing considerations, the fifth ground of appeal must be upheld and, accordingly, the judgment under appeal must be set aside in so far as the General Court dismissed the action on the ground that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability.

The request that the Court of Justice order the Commission to produce its entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42

The request that the Court of Justice order the Commission to produce its entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42

| 141 | In his appeal, the appellant requests, on the basis of Article 41 of the Charter, that the Court of Justice order the Commission to produce the entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42. |
| --- | --- |

141

In his appeal, the appellant requests, on the basis of Article 41 of the Charter, that the Court of Justice order the Commission to produce the entire file relating to the safeguard clause procedure under Article 8 of Directive 93/42.

| 142 | In that regard, it should be noted that the production of those documents would be of no use to the appellant since it has been found that the Commission’s unlawful conduct constituted a sufficiently serious breach of EU law and it has not been alleged that such documents would be useful in any further aspect in the context of the present appeal. |
| --- | --- |

142

In that regard, it should be noted that the production of those documents would be of no use to the appellant since it has been found that the Commission’s unlawful conduct constituted a sufficiently serious breach of EU law and it has not been alleged that such documents would be useful in any further aspect in the context of the present appeal.

| 143 | Therefore, there is no need to grant the request for further evidence submitted by the appellant. |
| --- | --- |

143

Therefore, there is no need to grant the request for further evidence submitted by the appellant.

| 144 | It follows from all of the foregoing considerations that the judgment under appeal must be set aside in so far as it concluded that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability. The remainder of the appeal must be dismissed. |
| --- | --- |

144

It follows from all of the foregoing considerations that the judgment under appeal must be set aside in so far as it concluded that the appellant had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability. The remainder of the appeal must be dismissed.

The action before the General Court

The action before the General Court

| 145 | In accordance with the second sentence of the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, in the event that the Court of Justice sets aside the decision of the General Court, it may itself give final judgment in the matter, where the state of the proceedings so permits. |
| --- | --- |

145

In accordance with the second sentence of the first paragraph of Article 61 of the Statute of the Court of Justice of the European Union, in the event that the Court of Justice sets aside the decision of the General Court, it may itself give final judgment in the matter, where the state of the proceedings so permits.

| 146 | That is the situation in the present case. In the light of the conditions for establishing non-contractual liability on the part of the European Union, as set out in paragraph 60 above, it is therefore necessary to examine whether the condition requiring establishment of the damage alleged and the condition requiring the existence of a causal link between the unlawful conduct — which has been found to constitute a sufficiently serious breach of EU law — and that damage, are satisfied. |
| --- | --- |

146

That is the situation in the present case. In the light of the conditions for establishing non-contractual liability on the part of the European Union, as set out in paragraph 60 above, it is therefore necessary to examine whether the condition requiring establishment of the damage alleged and the condition requiring the existence of a causal link between the unlawful conduct — which has been found to constitute a sufficiently serious breach of EU law — and that damage, are satisfied.

| 147 | As regards the damage alleged, it should be recalled that the damage for which compensation is sought in an action to establish non-contractual liability on the part of the European Union, under the second paragraph of Article 340 TFEU, must be actual and certain, which it is for the appellant to prove. It is for the latter to adduce conclusive proof as to both the existence and the extent of the damage he alleges (see, to that effect, judgment of 16 July 2009, SELEX Sistemi Integrati v Commission, C‐481/07 P, not published, EU:C:2009:461, paragraph 36 and the case-law cited). |
| --- | --- |

147

As regards the damage alleged, it should be recalled that the damage for which compensation is sought in an action to establish non-contractual liability on the part of the European Union, under the second paragraph of Article 340 TFEU, must be actual and certain, which it is for the appellant to prove. It is for the latter to adduce conclusive proof as to both the existence and the extent of the damage he alleges (see, to that effect, judgment of 16 July 2009, SELEX Sistemi Integrati v Commission, C‐481/07 P, not published, EU:C:2009:461, paragraph 36 and the case-law cited).

| 148 | In the present case, it is apparent from the conclusion in relation to the fourth ground of appeal raised by the appellant in support of the present appeal that he is entitled to rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik, and is not entitled to rely on rights to compensation associated with his personal situation or atmed. |
| --- | --- |

148

In the present case, it is apparent from the conclusion in relation to the fourth ground of appeal raised by the appellant in support of the present appeal that he is entitled to rely only on the rights to compensation transferred to him by Broncho-Air Medizintechnik, and is not entitled to rely on rights to compensation associated with his personal situation or atmed.

| 149 | Moreover, it follows from paragraph 54 of the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) that the appellant’s claim for compensation must in any event be rejected as inadmissible in so far as it relates to damage allegedly suffered before 15 September 2006. |
| --- | --- |

149

Moreover, it follows from paragraph 54 of the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) that the appellant’s claim for compensation must in any event be rejected as inadmissible in so far as it relates to damage allegedly suffered before 15 September 2006.

| 150 | Consequently, as noted by the Advocate General in point 45 of his Opinion, in application of the combined effect of the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) and the rejection of the first ground of appeal on that point, in paragraph 58 of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the appellant is entitled to claim compensation only for the damage allegedly suffered from 15 September 2006 in relation to Broncho-Air Medizintechnik. |
| --- | --- |

150

Consequently, as noted by the Advocate General in point 45 of his Opinion, in application of the combined effect of the judgment of 21 January 2014, Klein v Commission (T‐309/10, EU:T:2014:19) and the rejection of the first ground of appeal on that point, in paragraph 58 of the judgment of 22 April 2015, Klein v Commission (C‐120/14 P, not published, EU:C:2015:252), the appellant is entitled to claim compensation only for the damage allegedly suffered from 15 September 2006 in relation to Broncho-Air Medizintechnik.

| 151 | It must be pointed out that the determination of the extent of the rights to compensation with regard to Broncho-Air Medizintechnik for the period after 15 September 2006 may involve some specificities relating, in particular, to the fact that, as noted by the appellant, the action against the prohibition decision of 23 September 1997 adopted by the German authorities in relation to the Inhaler device had not been concluded at the time the application initiating proceedings was lodged. |
| --- | --- |

151

It must be pointed out that the determination of the extent of the rights to compensation with regard to Broncho-Air Medizintechnik for the period after 15 September 2006 may involve some specificities relating, in particular, to the fact that, as noted by the appellant, the action against the prohibition decision of 23 September 1997 adopted by the German authorities in relation to the Inhaler device had not been concluded at the time the application initiating proceedings was lodged.

| 152 | Nevertheless, the appellant cannot be entirely excused from the obligation to adduce proof of the damage he claims to have suffered. It falls to him, in relation to that type of material damage, to adduce evidence both of the existence of the damage and of the data on which he has based his assessment of that damage, given that such an assessment may not be performed merely on an equitable basis (see, to that effect, judgment of 16 July 2009, SELEX Sistemi Integrati v Commission, C‐481/07 P, not published, EU:C:2009:461, paragraph 37). |
| --- | --- |

152

Nevertheless, the appellant cannot be entirely excused from the obligation to adduce proof of the damage he claims to have suffered. It falls to him, in relation to that type of material damage, to adduce evidence both of the existence of the damage and of the data on which he has based his assessment of that damage, given that such an assessment may not be performed merely on an equitable basis (see, to that effect, judgment of 16 July 2009, SELEX Sistemi Integrati v Commission, C‐481/07 P, not published, EU:C:2009:461, paragraph 37).

| 153 | In that regard, the appellant, in his application initiating proceedings, has referred only to procedural costs and lawyers’ fees paid in connection with the action initiated in 1997 against the prohibition decision adopted by the German authorities in relation to the Inhaler device, without in any way quantifying the extent of such expenses, either by calculation or estimation. |
| --- | --- |

153

In that regard, the appellant, in his application initiating proceedings, has referred only to procedural costs and lawyers’ fees paid in connection with the action initiated in 1997 against the prohibition decision adopted by the German authorities in relation to the Inhaler device, without in any way quantifying the extent of such expenses, either by calculation or estimation.

| 154 | In those circumstances, the claim for compensation brought by the appellant must be rejected, as must the request for the appointment of an expert. |
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154

In those circumstances, the claim for compensation brought by the appellant must be rejected, as must the request for the appointment of an expert.

Costs

Costs

| 155 | Under Article 184(2) of the Rules of Procedure of the Court of Justice, where an appeal is well founded and the Court of Justice itself gives final judgment in the case, it is to make a decision as to costs. |
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155

Under Article 184(2) of the Rules of Procedure of the Court of Justice, where an appeal is well founded and the Court of Justice itself gives final judgment in the case, it is to make a decision as to costs.

| 156 | Under Article 138(3) of the Rules of Procedure, which is also applicable to appeal proceedings by virtue of Article 184(1) thereof, where each party succeeds on some and fails on other heads, the parties are to bear their own costs. However, if it appears justified in the circumstances of the case, the Court of Justice may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party. |
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156

Under Article 138(3) of the Rules of Procedure, which is also applicable to appeal proceedings by virtue of Article 184(1) thereof, where each party succeeds on some and fails on other heads, the parties are to bear their own costs. However, if it appears justified in the circumstances of the case, the Court of Justice may order that one party, in addition to bearing its own costs, pay a proportion of the costs of the other party.

| 157 | In the present instance, given that the judgment under appeal has been set aside in part but that the claim for compensation has been rejected, the appellant and the Commission are to be ordered to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings. |
| --- | --- |

157

In the present instance, given that the judgment under appeal has been set aside in part but that the claim for compensation has been rejected, the appellant and the Commission are to be ordered to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings.

| 158 | Article 140(1) of the Rules of Procedure, which is also applicable to appeal proceedings by virtue of Article 184(1) thereof, provides that the Member States and institutions which intervene in the proceedings are to bear their own costs. |
| --- | --- |

158

Article 140(1) of the Rules of Procedure, which is also applicable to appeal proceedings by virtue of Article 184(1) thereof, provides that the Member States and institutions which intervene in the proceedings are to bear their own costs.

| 159 | Therefore, as an intervener in the proceedings at first instance, the Federal Republic of Germany must bear its own costs in relation to those proceedings. |
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159

Therefore, as an intervener in the proceedings at first instance, the Federal Republic of Germany must bear its own costs in relation to those proceedings.

| | On those grounds, the Court (Third Chamber) hereby: |
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On those grounds, the Court (Third Chamber) hereby:

| | 1. | Sets aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‐309/10 RENV, not published, EU:T:2016:570), in so far as it held that Mr Christoph Klein had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability; |
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1.

1.

Sets aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‐309/10 RENV, not published, EU:T:2016:570), in so far as it held that Mr Christoph Klein had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability;

Sets aside the judgment of the General Court of the European Union of 28 September 2016, Klein v Commission (T‐309/10 RENV, not published, EU:T:2016:570), in so far as it held that Mr Christoph Klein had not established the existence of a direct and sufficient causal link capable of engaging the European Union’s liability;

| | 2. | Dismisses the appeal as to the remainder; |
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2.

2.

Dismisses the appeal as to the remainder;

Dismisses the appeal as to the remainder;

| | 3. | Dismisses the action brought by Mr Christoph Klein seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; |
| --- | --- | --- |

3.

3.

Dismisses the action brought by Mr Christoph Klein seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices;

Dismisses the action brought by Mr Christoph Klein seeking compensation for the damage allegedly sustained following a breach by the European Commission of its obligations under Article 8 of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices;

| | 4. | Orders Mr Christoph Klein and the European Commission to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings; |
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4.

4.

Orders Mr Christoph Klein and the European Commission to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings;

Orders Mr Christoph Klein and the European Commission to bear their own costs in relation to both the proceedings at first instance and the appeal proceedings;

| | 5. | Orders the Federal Republic of Germany to bear its own costs in relation to the proceedings at first instance. |
| --- | --- | --- |

5.

5.

Orders the Federal Republic of Germany to bear its own costs in relation to the proceedings at first instance.

Orders the Federal Republic of Germany to bear its own costs in relation to the proceedings at first instance.

| | [Signatures] |
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[Signatures]

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(
  *1
  )	Language of the case: German.

*1