Strasbourg, 17 December 2004

Dear Mr F.,

On 18 December 2003, you made a complaint to the European Ombudsman on behalf of PORTELA, Comércio de Artigos Ortopédicos e Hospitalares Lda, against the European Commission. It was your second complaint to the European Ombudsman against the Commission. The first was submitted on 11 February 2003 and concerned the lack of reply to your letter of 23 January 2003 (the case was closed as settled by the institution).

Your present complaint to the Ombudsman concerned a complaint submitted by you, on behalf of PORTELA, to the Commission's Enterprise Directorate-General on 27 November 2002.

On 15 January 2004, I forwarded the complaint to the President of the European Commission.

On 7 February 2004, you sent me a further document concerning your complaint.

On 5 May 2004, the Commission sent an opinion, which I forwarded to you with an invitation to make observations.

On 11 June 2004, I received your observations.

I am writing to let you know the results of the inquiries that have been made.

THE COMPLAINT

On the basis of the complaint and its annexes, the facts according to the complainant are summarised, in the following chronological order:

At the beginning of 2002, the complainant imported to Portugal digital thermometers manufactured by a Taiwanese company, the Geon Corporation (hereafter "the manufacturer").

The thermometers had EC certificates of conformity (certificate of Quality Management System and Approval of Quality Assurance System Production) dated 4 September 2001. The certificates were issued by a German institution, TUV-Rheinland, as Notified Body recognised by the Commission, according to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (hereinafter the Directive)(1), acting under the supervision of the German Competent Authority. The imported goods appeared to be defective and a threat to the health/life of users. The complainant received numerous claim letters and its commercial reputation was compromised.

On 7 August 2002, the complainant informed the German Notified Body about the defects and asked for compensation. The Notified Body registered the letter as a complaint report on 12 August 2002. On 15 October 2002, it replied to the complainant refusing to accept liability.

On 27 November 2002, the complainant lodged a complaint with the Commission's Enterprise DG against both the manufacturer of the defective products and the Notified Body. As regards the latter, the complaint concerned the failure of its quality management system and, as a result, a breach of the Directive. The complainant took the view that the Notified Body, according to the Directive (Article 5.3 and 5.4 of the Annex II) was obliged to conduct the post-marketing surveillance of the product: i.e. to check the quality system periodically also after the CE mark had been granted and not only at the time of certification. The complainant claimed that the CE certificate for the concerned product should be withdrawn. He also claimed that the Commission and the accrediting Member State should re-assess the competence of the Notified Body and consider withdrawal of its notification in terms of paragraph 6.2.2 of the Commission's Guide for the Implementation of Directives Based on New Approach and Global Approach(2).

On 20 March 2003, after the intervention of the European Ombudsman, the Commission replied to the complainant that it had requested explanations from the competent German and Portuguese institutions. The Commission also informed the complainant that the case was being analysed by the Notified Bodies Operations Group (NBOG) and Market Surveillance Operations Group (MSOG). The Commission's answer was headed: "Alleged breach of the Directive".

On 8 April 2003, the complainant formally notified the competent Portuguese authority responsible for the surveillance of the medical devices marketed in Portugal (Institute of Pharmaceutics and Medicines, hereafter "INFRAMED") about the defect in the product. Afterwards INFRAMED contacted the manufacturer for an explanation. It discovered that the manufacturer had no legal representative within the European Market as required by Article 14.2 of the Directive.

As a result, on 1 July 2003, INFRAMED decided to take regulatory action in accordance with the Directive and to suspend the sale of the product on the Portuguese market.

On 3 July 2003, the complainant sent a letter to INFRAMED expressing his concerns that his complaint to the Commission had not yet been resolved and that INFRAMED was not putting pressure on the German Competent Authority. He also informed INFRAMED that he had referred the case to SOLVIT(3) network Portugal which accepted it and forwarded it to SOLVIT Germany.

In its reply dated 21 August 2003, INFRAMED informed the complainant of its decision to suspend the sale of the product in accordance with Article 14b of the Directive and that, since the national procedures have been concluded, it expected an examination of the case by the Commission. It added that the suspension remained in force until the Commission would take a stance.

Concurrently, the complainant maintained a further exchange of correspondence with the Commission.

On 27 November 2003, the Commission informed the complainant, in laconic terms and without the above mentioned reference "alleged breach of the Directive ", that its intervention following the complainant's claim had been concluded and that a letter sent to the complainant by INFRAMED constitutes an answer to the complainant's questions. The Commission did not give more details concerning INFRAMED's letter except that the Commission has received its copy.

On 10 December 2003, the complainant asked the Commission to provide information on its position concerning PORTELA's case.

On 18 December 2003, the complainant lodged a complaint with the European Ombudsman.

The complainant alleged that the Commission failed to give reasons for its decision to close the file on the complaint submitted by PORTELA and failed to inform PORTELA of any possible further actions available to it.

The complainant claimed that the Commission should inform PORTELA about the measures (if any) that the Commission has taken in relation to the Notified Body.

The complainant also claimed that the Commission should clarify its position towards PORTELA's case and, in this indirect way, help it to receive compensation for its losses.

The complainant also stated that if the Portuguese Competent Authority (INFRAMED) had withdrawn the product from the market under the particular Health Monitoring measures, as introduced by the Directive, and if the Commission had agreed with that decision, it would have been obliged to adopt measures leading to the uniform application of the Directive throughout the Community, after consultation of the Regulatory Committee.

On 7 February 2004, the complainant forwarded to the Ombudsman a copy of a reply dated 12 January 2004, that he had received from the Commission to his letter dated 10 December 2003. The Commission stated that the complainant had not added anything to his earlier letters and should be satisfied (and happy) with the replies he had already received from the Commission. In a telephone conversation with the Ombudsman's services on 19 February 2004, the complainant explained that by sending the document, he did not intend to submit a new allegation but only asked that it be attached to his file.

THE INQUIRY

The Commission's opinion

The Commission's opinion included a large number of annexes reflecting its correspondence with the complainant and with national Portuguese and German competent authorities and also the correspondence of these authorities with the complainant and the manufacturer.

The Commission's opinion is summarised below under two headings (a-b):

a) Handling of the complaint

On 27 November 2002, the complainant sent a letter in Portuguese to the Commission referring to a batch of alleged defective thermometers imported by the complainant to Portugal from Geon Corporation of the Republic of China. The complainant took the view that the German Notified Body responsible for assessment of Geon Co.'s quality system did not carry out its assessment task properly.

A reply to the complainant was sent on 28 November 2002 announcing that the complaint was being translated into English so that it could be examined by the Sector of Medical Devices of Directorate General Enterprise.

On 18 December 2002, the Commission informed the complainant that the complaint was being considered by its legal services and that the matter would be referred to the Portuguese and German Competent Authorities as well as to the relevant Member States’working groups (respectively the Market Surveillance Operations Group, MSOG, and Notified Bodies Operations Group, NBOG). The Commission also stated that a substantive answer would be possible only after the Competent National Authorities informed the Commission on their opinion.

The German Competent Authority sent its comments to the Commission on 17 July 2003. The Portuguese Competent Authority sent its comments on 15 September 2003, after a series of reminders from the Commission.

The Portuguese Competent Authority, INFRAMED, took action within the framework of the vigilance procedure under Article 10 of the Directive. It issued a Vigilance Report referring to the defective nature of the product and the lack of information concerning an authorised representative and informed all Members States and third countries of the problem, thereby allowing them to take measures in case similar problems existed in their markets. (The Commission attached to its opinion INFRAMED's reply to the Commission dated 15 September 2003 with all the case documents, including INFRAMED's correspondence with the complainant and the manufacturer). In its letter dated 15 September 2003, INFRAMED informed the Commission that it had initiated a surveillance procedure, which culminated in the suspension in Portugal of the thermometers concerned under Article 14b of the Directive. Enclosed in the correspondence were letters from the manufacturer dated 9 July 2002 and 22 July 2002, addressed to the complainant, in which the manufacturer asked for the defective products to be returned for a refund and accepting responsibility. The Vigilance Report and the Global Medical Devices Competent Authority Report made by INFRAMED were also included.

The German Competent Authority's investigation of the Notified Body consisted in reviewing documents and making an on-site assessment. The German Competent Authority concluded that there was no failure in the assessment carried out by the Notified Body and that there were no reasons to take action against it. The reply dated 17 July 2003 of the German Competent Authority responsible for the accreditation of Notified Body (which was also sent in copy to the complainant on 3 September 2003) was annexed to the Commission's opinion. In this reply, the German Competent Authority informed the Commission that, according to the rules of the Directive, there was no indication that the accusations of PORTELA concerning the responsible Notified Body were justified. The German Competent Authority stated that the conformity assessment tasks of the Notified Body were limited to the manufacturing and final testing of the devices covered by the quality system and that it was the responsibility of the manufacturer to ensure and declare that the products comply with the provisions of the Directive. The German Competent Authority also stated that, due to the unclear reasons for the defect in the product and because the manufacturer had taken the appropriate steps, there were no grounds to withdraw the CE certificate up to that date.

Finally, the Commission pointed out that the complainant did not react to the proposal made by the manufacturer, which consisted of sending back the defective thermometers, nor did he claim a refund. Therefore, in spite of the complainant's request to be compensated for the losses that he had incurred, the Commission could take no action.

In summary, the Commission stated that it kept the complainant informed constantly and on an ongoing basis of the Commission’s position and did its best to support the complainant and to solve his problem. The Commission pointed out that in the light of German and Portuguese Competent Authorities' conclusions, which were communicated to the complainant, and following the acceptance of responsibility by the manufacturer, there was no further action the Commission could have taken. Therefore, the Commission services closed the case and informed the complainant accordingly in a letter dated 27 November 2003. The Commission also stated that in its reply to the complainant dated 12 January 2004, it referred to the closure of the case as well.

b) the Commission's action according to Article 14b of the Directive

The Commission identified the complainant's statement concerning measures leading to the uniform application of the Directive(4) as a separate allegation that the Commission had failed to adopt measures leading to the uniform application of the Directive, although it was obliged to do so. The Commission responded to the allegation as follows:

In his complaint to the Ombudsman, the complainant raised for the first time the question whether the Commission considers it necessary to adopt Community measures under Article 14b of the Directive.

The Commission took the view that the conditions for applying article 14b of the Directive were not met. When a product, although CE marked, does not meet the requirements of the Directive, action to remedy the situation should be taken by national authorities at the level of implementation: monitoring of Notified Bodies, Notified Bodies' action, vigilance or market surveillance (invoking a safeguard clause or undue CE marking). Given that the Competent Authorities of Portugal and Germany took all the appropriate measures (investigation of the alleged problem, inquiries to the Notified Body, the issuance of a Vigilance Report) and that they did not consider it necessary or justifiable to adopt extra safeguard measures (possible under Article 8 and 14b of the Directive), the Commission was not called upon to act.

The complainant's observations

The complainant sent his observations with a number of annexes. Among them there were two letters sent by the Commission to the complainant after the Ombudsman had opened his inquiry on the complaint (dated 17 February 2004 and 26 February 2004). In both letters, the Commission's arguments concerning handling of the complainant`s case and the Commission's action according to Article 14b of the Directive repeat, in summary, those included in its opinion sent to the Ombudsman.

The complainant's observations can be summarised as follows.

The complainant disagrees with the Commission’s statement in its opinion that the Competent Authorities of Portugal and Germany did not consider it necessary or justifiable to adopt extra safeguard measures (possible under Article 8 and 14b of the Directive) and that the Commission was not called upon to act. In particular, he did not agree with the Commission’s statement in its letter dated 17 February 2004, that the Portuguese Competent Authority did not notify the Commission of any measure under the Particular Health Monitoring Measures as specified by Article 14b of the Directive.

In this context, the complainant recalls INFRAMED's letter sent to him on 21 August 2003 and INFRAMED'S letter sent to the Commission on 15 September 2003. In both letters, according to the complainant, the Portuguese authority invoked Article 14b of the Directive as a legal basis for its action. The complainant also pointed out that in paragraph 22 of the Global Medical Devices Competent Authority Report INFRAMED stated that the product has been suspended under Article 14b of the Directive.

The complainant takes the view that the Commission assumes the position taken by the German Competent Authority that the responsibilities of the Notified Body were limited to the assessment procedure at the time of certification. The complainant quoted paragraph 8.2.3 of the Guide to the implementation of directives based on the new approach and the global approach: "actions must also be considered against the Notified Body if it was involved in the assessment procedure that had as a result, non-compliant product" and "in such cases, the competence of the notified body may need to be assessed as well".

According to the complainant, neither the Commission, nor the German Competent Authority made any reference to the surveillance responsibilities of the Notified Body under Annex V.4 of the Directive, nor to Annex II, Module D (12), 4.3 of Council Decision 93/465/EC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives: "the notified body must periodically carry out audits to make sure that the manufacturer maintains and applies the quality system".

The complainant takes the view that the Commission wrongly accepted the justification of the Competent German Authority concerning the reason for which the Notified Body did not have to withdraw the CE certificate (unclear reasons for the defect and the adequate steps undertaken by the manufacturer). The complainant points out in this context, that when the German Competent Authority adopted this position in its letter to the Commission, the product had been already withdrawn from the Portuguese market by the Portuguese Competent Authority and the manufacturer had acknowledged its responsibility in the production of the defective product (the manufacturer's letter dated 26 June 2003 was attached to the complainant's observations).

The complainant points out that the Commission does not allude to the fact that all manufacturers of Medical Devices must have an authorised representative for the Community market and that without an authorised representative an assessment procedure could have never taken place by the Notified Body.

The complainant notes that the Commission did not refer to the fact that the complainant's business was adversely affected due to the defective products (he had to close an entire department, dismiss employees, his sales were reduced) and argues instead that the complainant did not react to the manufacturer's proposals. Contrary to the Commission's statement, PORTELA did claim the first refund from the manufacturer but to date had not received payment.

The complainant also notes that neither the Commission nor the German Competent Authority refer to the fact that a Notified Body "must take out civil liability insurance" (paragraph 6, Annex XI of the Directive ) and "provide claims and litigation in the event of misadventure (…) that should in particular cover cases where the Notified Body may be obliged to withdraw or suspend certificates" (7.1 and 2, MEDDEV 2.10-2 Rev.1, April 2001, Designation and Monitoring of Notified Bodies within the framework of EC Directives on Medical Devices). The complainant considers that he is entitled to be compensated by the Notified Body and by anyone that might be considered responsible for the damage he suffered. Furthermore, he considers that the German Competent Authority has clearly failed to comply with its duties of the supervision of the assessment procedure by the Notified Body and it failed to demand the use of the compulsory civil liability insurance.

According to the complainant, the Commission’s abrupt closure of his case is unacceptable and a serious case of maladministration. Specifically, he takes the view that the Commission distorted in its comments the real content of the official documents issued by the Portuguese Competent Authority and that the CE mark system can only work if the Directives are fully respected.

Finally, the complainant also submits a new allegation that the Commission refused to act according to Article 226 of the EC Treaty, even though the actions of the Notified Body and German competent authority were incoherent and against Community law.

THE DECISION

1 Introductory remarks

1.1 The complainant, a Portuguese company (“PORTELA”) imported to Portugal digital thermometers with EC certificates of conformity issued by a German institution, TUV-Rheinland, as a Notified Body recognised by the Commission according to Directive. Since the digital thermometers appeared to be defective and unsafe, the complainant lodged a complaint with the Commission's DG Enterprise in November 2002, against both the manufacturer of the defective products and the Notified Body.

In the complaint to the Ombudsman, the complainant alleged that the Commission failed to give reasons for its decision to close the file on the complaint. He also alleged that the Commission failed to inform PORTELA of any possible further actions available to it.

The complainant claimed that the Commission should inform PORTELA about the measures (if any) that the Commission has taken in relation to the Notified Body. The complainant also claimed that the Commission should clarify its position towards PORTELA's case and, in this indirect way, help it to receive compensation for its losses.

The complainant also stated that if the Portuguese Competent Authority (INFRAMED) had withdrawn the product from the market under the particular Health Monitoring measures, as introduced by the Directive, and if the Commission had agreed with that decision, it would have been obliged to adopt measures leading to the uniform application of the Directive throughout the Community, after consultation of the Regulatory Committee. The complainant referred to Article 14b of the Directive. In its opinion, the Commission identified and replied to the complainant's statement as a separate allegation that the Commission had failed to adopt measures leading to the uniform application of the Directive although it was obliged to do so.

1.2 The Ombudsman will deal with the complainant's allegations and claims in the following order:

- First, the alleged failure to adopt measures leading to the uniform application of the Directive;

- Second, the alleged failures to give reasons and to provide information, and the related claims that the Commission should inform PORTELA about the measures, if any, that the Commission has taken in relation to the Notified Body and that the Commission should clarify its position towards PORTELA's case and, in this indirect way, help it to receive compensation for its losses.

1.3 In his observations, the complainant also submitted a new allegation that the Commission refused to act according to Article 226 of the EC Treaty even though the actions of the Notified Body and German Competent Authority were incoherent and against Community law.

The Ombudsman considers that the new allegation raises substantially different issues from the original complaint and that it is therefore not appropriate to delay a decision on the original complaint in order to make further inquiries. The Ombudsman points out, however, that the complainant has the possibility to make a new complaint on this matter, if he considers it useful to do so.

2 The alleged failure to adopt measures leading to the uniform application of the Directive

2.1 In his original complaint, the complainant stated that if the Portuguese Competent Authority (INFRAMED) had withdrawn the product from the market under the particular Health Monitoring measures, as introduced by the Directive, and if the Commission had agreed with that decision, it would have been obliged to adopt measures leading to the uniform application of the Directive throughout the Community, after consultation of the Regulatory Committee. The complainant referred to Article 14b of the Directive.

2.2 The Commission identified and replied to the complainant's statement as a separate allegation that the Commission had failed to adopt measures leading to the uniform application of the Directive, although it was obliged to do so. The Commission responded to the allegation as follows:

The Commission took the view that the conditions for applying Article 14b were not met. Where a product, although CE marked, does not meet the requirements of the Directive, action to remedy the situation should be taken at the level of implementation: monitoring of Notified Bodies, Notified Bodies' action, vigilance or market surveillance (invoking a safeguard clause or undue CE marking).

In the Commission's view, the Competent National Authorities in Portugal and Germany took all the appropriate measures (investigation of the alleged problem, inquiries to the Notified Body by the German competent authority, the issuance of a vigilance report in terms of Art. 10 of the Directive by INFRAMED) and did not consider it necessary or justifiable to adopt extra safeguard measures (possible under Article 8 and 14b of the Directive). For that reason, according to the Commission, it was not called upon to act.

2.3 The Ombudsman first observes that Art. 14b of the Directive provides as follows: "Where a Member State considers in relation to a given product or group of products, that, in order to ensure protection of health of safety and/or to ensure that public health requirements are observed pursuant to Article 36 of the EC Treaty, the availability of such products should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures. It shall then inform the Commission and all the other Member States giving the reasons for its decision. The Commission shall, whenever possible, consult the interested parties and the Member States and, where the national measures are justified, adopt necessary Community measures in accordance with the procedure referred to in Article 7(2)." Art. 7 (2) of the Directive provides: "The representative of the Commission shall submit to the Committee a draft of the measures to be taken(...)."

2.4 As regards the facts of the present case, the Ombudsman finds the following on the basis of the documentary evidence supplied by the complainant and the Commission:

INFRAMED issued vigilance report PT-2003-07-01-001, under Article 10 of the Directive which was sent to its counterparts in all Member States on 1 July 2003 (reference Number DGREE/VPS/137/03).

INFRAMED also issued the Global Medical Devices Competent Authority Report with the same reference PT-2003-07-01-001. Paragraph 22 of the Report stated that the suspension of sale of the product concerned occurred under article 14b of the Directive. This report was attached to the letter of INFRAMED to DG Enterprise of the European Commission, dated 15 September 2003 (Ref. DGREE/VPS/290/03). In that letter, which was an official answer to the Commission concerning the complainant's case, INFRAMED stated that "it initiated a vigilance procedure which culminated in the suspension of the sale in Portugal of thermometers concerned under Art.14b of the Directive."(5)

In its letter to the complainant dated 21 August 2003 (Ref. DGREE/VPS/262/03), INFRAMED mentioned the legal ground for a safeguard clause, i.e. Article 14b of the Directive when deciding on the suspension of the product and stated that after the national procedure had been concluded, it awaited the examination of the case by the Commission and that in the meantime the suspension of the sale of the product remained in force.

2.5 The Ombudsman notes that according to paragraph 8.3.2 of the Commission's Guide for the Implementation of Directives Based on New Approach and Global Approach(6), as soon as a competent national authority restricts (…) the free movement of a product in such a way that the safeguard clause is invoked, the Member State must immediately notify the Commission indicating the reasons and justification for the decision. (…) and that the official notification usually takes place via the Permanent Representation with a copy sent to the Commission department responsible for managing the Directive in question.

2.6 In view of the above provision, the Ombudsman takes the view that, despite the terms of INFRAMED’s letter of 21 August 2003 to the complainant, it is doubtful whether INFRAMED’s subsequent letter of 15 September 2003 to the Commission could be considered as an official notification by which the safeguard clause is invoked, in terms of the Guide provisions. Furthermore, no such notification appears elsewhere among the documents sent to the Ombudsman.

2.7 Moreover, the Ombudsman takes the view that any further inquiries into the question of whether the Commission was obliged to act according to Article 14b of the Directive would necessarily involve an examination of the adequacy and appropriateness of the measures taken by the Portuguese Competent Authority INFRAMED. The Ombudsman points out in this regard that his powers are limited by the Treaty to inquiring into possible instances of maladministration in the activities of the Community institution or bodies.

2.8 In the light of the above, the Ombudsman considers that no further inquiries into this aspect of the complaint are justified.

3 Alleged failure to state reasons for the decision and to provide information and related claims

3.1 The complainant alleges that the Commission failed to give reasons for its decision to close the file on the complaint submitted by PORTELA.

He also alleges that the Commission failed to inform PORTELA of any possible further actions available to it.

He claims that the Commission should inform PORTELA about the measures, if any, that the Commission has taken in relation to the Notified Body.

The complainant also claims that the Commission should clarify its position towards PORTELA's case and, in this indirect way, help it to receive compensation for its losses.

3.2 In its opinion, the Commission considered that it informed the complainant in a letter dated 26 November 2003 that it had closed the case. The Commission also stated that its reply to the complainant dated 12 January 2004 (attached to its opinion) referred to the closure of the case as well.

The Commission also provided thorough information on the investigation of the Notified Body by the German Competent Authority, which was carried out at the Commission's request and on the action undertaken by the Portuguese Competent Authority. The Commission pointed out that, in the light of the German and Portuguese Competent Authorities' conclusions, it closed the case.

3.3 The Ombudsman notes that, in its letter to the complainant dated 27 November 2003, the Commission communicated only the following information: (1) that it had decided to close the complainant’s case, and (2) that a letter addressed to him by the Portuguese Competent Authority constitutes an answer to his questions. The Commission did not identify the letter to which it referred.

3.4 Furthermore, the Ombudsman notes with surprise that in its letter to the complainant dated 12 January 2004 (mentioned by the Commission in its opinion), the Commission did not provide any new information and said instead that the complainant should be satisfied (and happy) with the replies he had already received(7).

3.5 The Ombudsman notes, however, that in its letters sent to the complainant after the Ombudsman had opened his inquiry (dated 17 and 24 February 2004) and forwarded to the Ombudsman by the complainant, the Commission appears to provide more information concerning the closure of the complainant's case.

3.6 The Ombudsman recalls that according to the established case-law(8), the reasons for a decision must disclose in a clear and unequivocal fashion the reasoning followed by the institution which adopted the decision in such a way as to enable the persons concerned to ascertain the reasons for the measure.

3.7 The Ombudsman also points out that principles of good administration require the Community institutions to state the grounds on which the decision is based by indicating clearly the relevant facts and the legal basis of the decision(9). These principles also require the institutions to indicate the appeal possibilities available for challenging the decision(10).

Furthermore, the Ombudsman points out that according to the Commission's own Code of Good Administrative Behaviour, a decision by the Commission should clearly state the reasons on which it is based(11).

In the present case, the Commission referred in its decision closing the complainant’s case to an unidentified letter of the Portuguese Competent Authority to the complainant. The Ombudsman considers, however, that the complainant was not capable on the basis of such reference to ascertain the Commission’s reasons for adopting the decision and, if necessary, to challenge it.

3.8 In view of the above, the Ombudsman considers that by referring the complainant only to an unidentified letter of the Portuguese competent authority, the Commission failed to give reasons for its decision and to provide information on possible avenues of redress available to the complainant. This was an instance of maladministration. The Ombudsman will therefore make a critical remark with regard to this aspect of the complaint.

3.9 However, the Ombudsman notes that the Commission has already taken appropriate action in response to this aspect of the complaint, by providing more information concerning the closure of the complainant's case in its letters to the complainant dated 17 and 24 February 2004.

Conclusion

On the basis of the Ombudsman's inquiries into the complaint, it is necessary to make the following critical remark:

Principles of good administration require the Community institutions to state the grounds on which the decision is based by indicating clearly the relevant facts and the legal basis of the decision(12). These principles also require the institutions to indicate the appeal possibilities available for challenging the decision(13). In the present case, the Ombudsman considers that by referring the complainant only to an unidentified letter of the Portuguese competent authority, the Commission failed to state reasons for its decision and to provide information on possible avenues of redress available to the complainant. This was an instance of maladministration.

Given that the Commission has already taken appropriate action in response to this aspect of the complaint, it is unnecessary to pursue a friendly settlement of the matter. The Ombudsman therefore closes the case.

The President of the European Commission will be informed of this decision.

Yours sincerely,

 

P. Nikiforos DIAMANDOUROS

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(1) Directive 93/42/EEC was amended by Article 21 of Directive 98/79/EC (OJ L 331/13): Articles 1 (2), 2 and 22(4) were replaced by new provisions, new Articles 14 a and 14 b, one sentence to Annex XI, section 3 and new paragraphs to Articles 16 and 18 were inserted, and sections of several Annexes were deleted (Annex II, section 6.2, Annex III, section 7.1, Annex V, section 5.2 and Annex VI, section 5.2).

(2) The Guide can be consulted at: http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

(3) In its reply dated 21 August 2003, INFRAMED informed the complainant of its decision to suspend the sale of the product in accordance with Article 14b of the Directive and that, since the national procedures have been concluded, it expected an examination of the case by the Commission. It added that the suspension remained in force until the Commission would take a stance.

(4) In his original complaint, the complainant stated that if the Portuguese Competent Authority (INFRAMED) had withdrawn the product from the market under the particular Health Monitoring measures, as introduced by the Directive, and if the Commission agreed with that decision, it would have been obliged to adopt measures leading to the uniform application of the Directive throughout the Community, after consultation of the Regulatory Committee (the complainant referred thus to Article 14 b of the Directive).

(5) In original in Portuguese: "Face ao assunto exposto pela referida empresa, encetou o INFRAMED um procedimento de vigilância que culminou na suspensão da comercialização em Portugal dos referidos termómetros, com base no art. 14ºb)da Directiva 93/42/CEE:".

(6) The Guide can be consulted at: http://ec.europa.eu/enterprise/newapproach/legislation/guide/index.htm

(7) In Portuguese: "(...) terá pois de se contentar, e conformar, com as respostas que já obteve".

(8) See case T-290/02, Ascontex v. Commission, judgement of the Court of First Instance of 14 September 2004, paragraph 73 and case C-367/95 P, Commission v Sytraval and Brink’s France [1998] ECR I-1719, paragraph 63, and the case-law cited there.

(9) Article 18 of the European Code of Good Administrative Behaviour available on the Ombudsman's website: http://www.ombudsman.europa.eu

(10) Article 19 of the European Code of Good Administrative Behaviour available on the Ombudsman's website: http://www.ombudsman.europa.eu

(11) Article 3 of the Code of Good Administrative Behaviour for Staff of the European Commission in their Relations with the Public available on the Commission's website: http://www.europa.eu/comm/secretariat_general/code/index_en.htm

(12) Article 18 of the European Code of Good Administrative Behaviour available on the Ombudsman's website: http://www.ombudsman.europa.eu

(13) Article 19 of the European Code of Good Administrative Behaviour available on the Ombudsman's website: http://www.ombudsman.europa.eu