Has the CE mark lost its appeal for novel medical device developers?

Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report.

“Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the study, published by Boston Consulting Group and the UCLA Biodesign innovation hub.

They surveyed and interviewed leaders and executives at 102 companies that have achieved registration or approval of a combined 105 novel technologies. A little more than half of the respondents said they are deprioritizing the CE mark relative to FDA approval.

Of the companies surveyed, 90 are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.

Industry executives described product registration and approval as “cumbersome and uncertain” under…

Read more
  • 0

Here’s how the UK will regulate medical devices after Brexit

Image from Jonathan Chng on Unsplash

The United Kingdom issued an outline of how it intends to regulate medical devices beginning in 2021 after Brexit.

From Jan. 1, 2021, the responsibilities for the UK medical devices market that are currently governed by the European Union (EU) will be taken over by the Medicines and Healthcare products Regulatory Agency (MHRA), the guidance said.

Changes to how medical devices reach the market in the UK will be implemented over time, although CE Mark approval will continue to be used and recognized until June 30, 2023, as will certificates issued by European Economic Area (EEA)-based notified bodies.

After Jan. 1, 2021, all medical devices and in vitro diagnostic medical devices placed on the UK market must be registered with the MHRA, although a grace period for registering includes:

Four months for Class IIIs and Class IIb implantables, and all activ…
Read more
  • 0