2 Amendments of Andreas SCHWAB related to 2018/0018(COD)
Amendment 80 #
Proposal for a regulation
Article 3 – paragraph 8 – point d
Article 3 – paragraph 8 – point d
(d) ensure appropriate and regular involvement of stakeholders in its work;
Amendment 107 #
Proposal for a regulation
Article 6 – paragraph 14 a (new)
Article 6 – paragraph 14 a (new)
14 a. When receiving the joint clinical assessment report and the summary report, the health technology developer may hand in a detailed objection in writing to the Coordination Group within seven working days. The Coordination Group shall evaluate the objections within 30 working days and may revise the report if necessary. It shall approve and submit the final joint clinical assessment report, the summary report and an explanatory document setting out how the objections were addressed.