9 Amendments of Miroslav MIKOLÁŠIK related to 2018/0018(COD)
Amendment 272 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Coordination Group shall act by consensus, or, where necessary, vote by simplequalified majority. There shall be one vote per Member State.
Amendment 312 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 315 #
Proposal for a regulation
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
Article 5 – paragraph 1 – point b – subparagraph 1 a (new)
The Commission shall, by means of Delegated Acts, include in Article 5 paragraph 1 of this Regulation a specific product category of medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of medical devices.
Amendment 317 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 320 #
Proposal for a regulation
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
Article 5 – paragraph 1 – point c – subparagraph 1 a (new)
The Commission shall, by means of Delegated acts, include in Article 5 paragraph 1 of this Regulation a specific product category of in vitro diagnostic medical devices if at least five Member States are systematically performing health technology assessments on the same specific product category of in vitro diagnostic medical devices.
Amendment 329 #
Proposal for a regulation
Article 6 – paragraph 1 – subparagraph 1
Article 6 – paragraph 1 – subparagraph 1
The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group. Member States may propose additional comparator, which from their point of view represents the relevant evidence-based standard of care in their Member State. In case this proposal has not been taken into account, the relevant Member State may use the mechanism referred to in Article 8 – paragraph 1 a (new).
Amendment 399 #
Proposal for a regulation
Article 6 – paragraph 12
Article 6 – paragraph 12
12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States.
Amendment 436 #
Proposal for a regulation
Article 8 – paragraph 1 a (new)
Article 8 – paragraph 1 a (new)
1a. This shall not prevent the Member States from complementing the joint clinical assessment with clinical assessments comparing the technology against a comparator which represents the best available evidence based standard of care in this Member State which, despite the Member States request during the scoping face, will not form part of the joint clinical assessment and which is necessary to complete the health technology assessment in that Member State. Any such measure should be justified, necessary and proportionate to achieving this aim. Any national assessment complementing the joint clinical assessment should follow the methodology established in accordance with Article 22. Member States shall notify the Commission and the Coordination Group of their intention to complement the joint clinical assessment together with a justification for doing so no later than 2 weeks after the Coordination Group has laid down the specific requirements for the joint assessment of the specific technology.
Amendment 486 #
Proposal for a regulation
Article 13 – paragraph 12
Article 13 – paragraph 12
12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simplequalified majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.