10 Amendments of Mairead McGUINNESS related to 2018/0018(COD)
Amendment 203 #
Proposal for a regulation
Recital 12
Recital 12
(12) In order to ensure a wide application of harmonised rules on clinical aspects of HTA and enable pooling of expertise and resources across HTA bodies, it is appropriate to require joint clinical assessments to be carried out for all medicinal products undergoing the central marketing authorisation procedure provided for under Regulation (EC) No 726/2004 of the European Parliament and of the Council,11 which incorporate a new active substance, and where those medicinal products are subsequently authorised for a new therapeutic indication. Joint clinical assessments should also be carried out on certain medical devices within the meaning of Regulation (EU) 2017/745 of the European Parliament and of the Council12 which are in the highest risk classes and for which the relevant expert panels have provided their opinions or views. A selection of medical devices for joint clinical assessment should be made based on specific criteria. __________________ 11 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 12Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 220 #
Proposal for a regulation
Recital 18
Recital 18
(18) The establishment of a time-frame for the joint clinical assessments for medical devices should take into account the highly decentralised market access pathway for medical devices and the availability of appropriate evidence data required to carry out a joint clinical assessment. As the required evidence may only become available after a medical device has been placedRegulations (EU) 2017/745 and (EU) 2017/746 set new requirements for high-quality data on the safety and efficacy of medical devices and in-vitro medical devices, which include clinical investigations and evidence on the clinical benefit onf the market and in order to allow for the selection of medical devices for joint clinical assessment at an appropriate time, it should be possible for assessments of such devices to take place following market launch of medical devicesdevices. Therefore medical devices and in-vitro medical devices shall not be part of the EU joint assessment.
Amendment 223 #
Proposal for a regulation
Recital 19
Recital 19
(19) In all cases the joint work carried out under this Regulation, in particular the joint clinical assessments, should produce high quality and timely results, and not delay or interfere with the CE marking of medical devices or market accesset access of health technologies. This work focusses solely on the efficacy of health technologies. This work and should be separate and distinct from regulatory assessments of the safety, quality, efficacy or performance of health technologies carried out pursuant to other Union legislation and have no bearing on decisions taken in accordance with other Union legislation.
Amendment 313 #
Proposal for a regulation
Article 5 – paragraph 1 – point b
Article 5 – paragraph 1 – point b
Amendment 319 #
Proposal for a regulation
Article 5 – paragraph 1 – point c
Article 5 – paragraph 1 – point c
Amendment 321 #
Proposal for a regulation
Article 5 – paragraph 2
Article 5 – paragraph 2
Amendment 451 #
Proposal for a regulation
Article 11 – paragraph 1 – point f
Article 11 – paragraph 1 – point f
Amendment 498 #
Proposal for a regulation
Article 16 – paragraph 1 – point f
Article 16 – paragraph 1 – point f
Amendment 507 #
Proposal for a regulation
Article 18 – paragraph 2 – point e
Article 18 – paragraph 2 – point e
Amendment 598 #
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 1 (new)
Article 36 – paragraph 2 – subparagraph 1 (new)
5 years after the date of application, the Commission shall review the scope of the Regulation to include high-risk medical devices classified as class IIb and III pursuant to Article 51 of regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation or in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation, where appropriate. The Commission shall take into account the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.