Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms
This article was originally published in The Gray Sheet
Executive Summary
The Committee held a workshop Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight. Some members of Parliament and others in Europe believe the proposal may not go far enough when it comes to pre-market oversight.
You may also be interested in...
EU Parliament Panel OKs Pre-Market Review Process Derided By Industry
The compromise pre-market provisions merge components of a pre-market “scrutiny” procedure proposed last year by the European Commission and proposals from legislators seeking even stricter pre-market oversight. The CEO of the industry trade group Eucomed calls it a “PMA in disguise carried out on a case-by-case basis” and says it will harm innovation and patient access to new technologies if adopted.
EU Parliament Considers More Stringent Medical Device Regulations
EU Parliament committee continues debate on medical device regulations, focusing on pre-market approval, scrutiny of notified bodies and post-market surveillance.
European Regulation Looms Over Mobile Health
The mHealth Regulatory Coalition, an industry group that has been focused on the U.S., is expanding its advocacy efforts to Europe, where a “regulatory revolution” is brewing that has the potential to upend mHealth and digital health business models.