Eucomed laments EU decision
This article was originally published in The Gray Sheet
Executive Summary
Regulatory costs for combination products could "multiply drastically," Eucomed warns in reaction to a Dec. 17 vote by the European Parliament failing to "turn down an amendment suggesting the primacy of the revised Directive 2001/83/EC." Parliament's failure to vote on the issue will introduce "legal uncertainty and confusion" for devices that also contain a drug component, Eucomed says. The Parliament previously has voted to define drugs as products that have pharmacological action "as their primary mode of action" (1"The Gray Sheet" Oct. 28, 2002, p. 18)...
You may also be interested in...
EU Industry Still Wary Of Borderline Devices After Positive Parliament Vote
The European Parliament's device-supporting plenary session vote Oct. 23 in Strasbourg largely rejects the suggested primacy of the revised Directive 2001/83/EC on the Community Code relating to Medicinal Products for Human Use over the Medical Devices Directive
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.
Takeda, Astellas Found New JV To Support Japanese Bioventures
Major Japanese companies Takeda, Astellas and SMBC are joining hands to establish a new joint venture with $3.9m capital and based in Japan’s largest biocluster Shonan iPark to help incubate local biopharma start-ups.