Shortage of MDR Notified Bodies: Crisis Averted or Crisis Delayed?

article image

The decision to push back MDR’s implementation date by one year ostensibly bought companies and regulators time to prepare for the new system. But there remains a continuing scarcity of new notified bodies. Is that an indication that European officials are just kicking the can down the road so that industry can still expect a bottleneck, just one year later?

At the risk of dating myself, watching what is going on with the impending European Medical Device Regulation (MDR) reminds me of the Monty Python TV sketch that opens with the line, “No one expects the Spanish Inquisition!”

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
Subscribe to ELITE Strategist

Become an ELITE Strategist and unlock access to both MedTech Strategist and MTS Market Pathways.

Subscribe to Elite


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