What is MEDDEV 2.7/1 Rev. 4?

MEDDEV 2.7/1 Rev. 4 Definition

MEDDEV 2.7/1 Rev. 4 is a document published by the European Commission which provides guidance to manufacturers on how often they should update the clinical evaluation of their medical devices and introduce new methodologies. The document also specifies the roles and actions required by notified bodies.

What is MEDDEV 2.7/1 Rev. 4

The Cost

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.