BETA

Activities of Jolanta Emilia HIBNER related to 2012/0266(COD)

Plenary speeches (1)

In vitro diagnostic medical devices - Medical devices (debate)
2016/11/22
Dossiers: 2012/0266(COD)

Amendments (5)

Amendment 286 #
Proposal for a regulation
Article 5 – paragraph 2 a (new)
2 a. Service providers providing means of distance communication shall be obliged, upon receiving a request from the competent authority, to disclose the details of entities engaging in distance selling.
2013/05/14
Committee: ENVI
Amendment 287 #
Proposal for a regulation
Article 5 – paragraph 2 b (new)
2 b. There shall be a prohibition on the marketing, placing in use, distribution, delivery and making available of products whose names, labelling or instructions for use may mislead with regard to the product’s characteristics and effects by: a) ascribing characteristics, functions and effects to the product which the product does not have; b) creating the false impression that treatment or diagnosis using the product is sure to be successful, or failing to inform of a likely risk associated with the use of the product in line with its intended use or for a longer-than-anticipated period; c) suggesting uses or characteristics of the product other than those declared when the conformity assessment was carried out. Promotional materials, presentations and information about the products may not mislead in the manner referred to in the first sentence.
2013/05/14
Committee: ENVI
Amendment 315 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
10 a. The manufacturer of the product is responsible for the product, for carrying out a conformity assessment procedure on the product prior to placing it on the market, and for placing the product on the market. If the manufacturer is not resident or established in a Member State, an authorised representative shall bear responsibility for the product. If the manufacturer has not designated an authorised representative, or if the manufacturer or authorised representative is not responsible for placing the product on the market, responsibility shall be borne by the entity that placed the product on the market.
2013/05/14
Committee: ENVI
Amendment 607 #
Proposal for a regulation
Article 47 – paragraph 3
3. Upon request by a Member State and where this is in the interest of public health or patient safety in more than one Member State, the Commission may, by means of implementing acts, extend for a determined period of time the validity of an authorisation granted by a Member State in accordance with paragraph 1 to the territory of the Union and set the conditions under which the device may be placed on the market or put into service. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). On duly justified imperative grounds of urgency relating to the health and safety of humans, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 88(4).deleted
2013/05/14
Committee: ENVI
Amendment 787 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point a a (new)
(a a) The name of the product may not allude to the name of a medicinal product, a biocidal product, a cosmetic product or a diet supplement.
2013/05/14
Committee: ENVI