Pathways’ Picks June 15: EU MDR Pressures, Senate Split Emerges, And More

article image

In this week’s roundup: EU policymakers build pressure on industry to comply with the Medical Device Regulation as soon as possible; senators advance FDA legislation but show a growing partisan split; some medtech amendments to the moving user fee legislation address device modifications, export certificates, and waived registration fees; new leadership at the Medical Device Innovation Consortium, CPT panel updates, and more.

Top Pick

EU escalates MDR rhetoric:

Don’t expect the EU government to bail your company out if it hasn’t transitioned all of its devices to the Medical Device Regulation by 2024, the European Commission’s Medical Device Coordination Group (MDCG) warns in a position paper. Soon after national European competent authorities expressed urgency about MDR challenges, MDCG says device firms need to take responsibility for getting quality, complete MDR applications in to notified bodies ASAP or risk noncompliance. Read more: “EU Commission Ratchets Up Pressure on Companies to Expedite MDR Compliance,” Market Pathways, June 14, 2022.)


This article is restricted to subscribers only.

To continue reading, select one of the options below:

Existing Subscriber?

Sign In to continue reading.

Need Multi-User Access?

Gain access for your entire organization.

Get Quote Check to see if your company already has access

Subscribe to Market Pathways:

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Subscribe to Market Pathways
Sign up for All-Access

Join our global community with a subscription to both MedTech Strategist and Market Pathways for one low price.



We're here to help! Please contact us at: