Answer given by Mr Verheugen on behalf of the Commission
The Commission was recently informed of the case reported by the Honourable Member and has contacted the Romanian authorities requiring communication of the measures adopted to ensure the withdrawal of the concerned product from the market. Following the information received, the concerned product was withdrawn from the market.
The general legal situation is the following:
Surgical threads are considered medical devices according to Directive 93/42/EEC(1). In accordance with Article 2 of the directive, the Member States have the responsibility to ensure that medical devices are placed on the market and/or put into service only if they comply with the requirements laid down in the directive.
The concerned devices must meet the essential requirements laid down in Annex I of the directive which apply to them, taking into account the intended purpose of the devices. When considered to meet the essential requirements, they must bear the CE marking of conformity pursuant to Article 3 and Article 17, paragraph 1 respectively.
Where a Member State establishes that the CE marking is missing in violation of the directive, the manufacturer or his authorised representative shall be obliged to end the infringement under the conditions imposed by that Member State. Where non‑compliance continues, the Member State must take all appropriate measures to ensure that the concerned devices are withdrawn from the market, in accordance with Article 18 of the directive.
The Commission has the duty to ensure Member States comply with the requirements of the directive and fulfil their obligations accordingly. Since the surgical thread imported from China was not CE marked, the Romanian Competent Authority had the obligation to act according to Article 18. Articles 18 and 19 of Regulation (EC) No 765/2008 of the Parliament and of the Council(2) are setting out the requirements for accreditation and market surveillance relating to the marketing of products. These articles list the requirements for the effective organisation of national market surveillance. Market surveillance by Member States will be enhanced with the entry into force of the abovementioned regulation, as of 1 January 2010.