12 Amendments of Christofer FJELLNER related to 2012/0266(COD)
Amendment 181 #
Proposal for a regulation
Recital 35
Recital 35
(35) Transparency and better information that is understandable, reliable, objective, easily accessible and non-promotional are essential to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.
Amendment 198 #
Proposal for a regulation
Recital 48
Recital 48
(48) An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database. To protect the right to the protection of personal data, recognised by Article 8 of the Charter of Fundamental Rights of the European Union, no personal data of subjects participating in a clinical investigation should be recorded in the electronic system. To ensure synergies with the area of clinical trials on medicinal products, the electronic system on clinical investigations on medical devices should be interoperable with the EU database, as well as the www.clinicaltrials.gov database of the USA FDA to be set up for clinical trials on medicinal products for human use.
Amendment 236 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Amendment 258 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 24
Article 2 – paragraph 1 – subparagraph 1 – point 24
(24) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health;
Amendment 282 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Devices that are manufactured and used within a single health institution shall be considered as being put into service. The provisions regarding CE marking referred to in Article 18 and the obligations laid down in Articles 23 to, 26 and 27 shall not apply to those devices, provided that manufacture and use of those devices occur under the health institution's single quality management system.
Amendment 385 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person, including health institutions as specified at Art. 4.4, who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 481 #
Proposal for a regulation
Article 28 – paragraph 1 – point 1 (new)
Article 28 – paragraph 1 – point 1 (new)
(1) Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.
Amendment 492 #
Proposal for a regulation
Article 31 – paragraph 2 – subparagraph 1
Article 31 – paragraph 2 – subparagraph 1
The application shall specifybe accompanied by a description of the conformity assessment activities, the conformity assessment procedures and the devices for which the body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Annex VI or supported by documentation proving compliance with all the requirements set out in Annex VI.
Amendment 493 #
Proposal for a regulation
Article 31 – paragraph 2 – subparagraph 2
Article 31 – paragraph 2 – subparagraph 2
Amendment 562 #
Proposal for a regulation
Article 44
Article 44
Amendment 717 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 904 #
Proposal for a regulation
Annex 15
Annex 15