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Parliamentary questions
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21 May 2019
Answer given by Ms Bieńkowska on behalf of the European Commission
Question reference: E-001151/2019

Article 2 of Regulation (EU) 2017/745(1) provides a definition of a medical device which is based on a medical intended purpose of the product, for example treatment or alleviation of disease or injury. As personal hygiene products such as tampons typically do not have any of the medical intended purposes listed in Article 2, they would usually not be qualified as medical devices.

The regulatory status of products with respect to Regulation (EU) 2017/745 is determined by manufacturers, notified bodies and national competent authorities case-by-case based on the above definition. Thus there is no list of medical devices.

Directive 2001/95/EC(2) on general product safety indeed obliges producers to place only safe products on the market (Article 3(1)). Producers are responsible for the safety of products they place on the market, while Member States authorities are responsible for the enforcement, and shall take actions if unsafe products are found on the market.

In addition, risks related to chemicals are covered by the EU chemicals legislation, in particular REACH(3). If the presence of hazardous substance in such articles poses a risk to health or to the environment which is not adequately controlled, Member States or the European Chemicals Agency (ECHA) may prepare a restriction proposal.

The Commission is committed to ensuring a high level of safety of consumers. In this specific case, the Commission considers that the existing regulatory framework, when properly enforced by the Member States, provides the adequate level of safety for consumers.

(1)OJ L 117, 5.5.2017, p. 1‐175
(2)OJ L 11, 15.1.2002, p. 4
(3)OJ L 396, 30.12.2006, p.1.

Last updated: 23 May 2019Legal notice