Update Factory

Stay up to date from a clinical and regulatory perspective in the Medtech sector

Our Update Factories provide compact learnings on current regulatory developments. They help understand changes and their impact on your organization early, and enable you to develop appropriate next steps.

Article 61 (10) Team NB - Positioning Paper

What we’ll be covering:

What a well-founded justification under Article 61(10) must include—and what the Notified Body typically looks for
Common deficiencies seen in submissions, and practical ways to avoid them (before they become findings)

already over

MDR Delegated Act WET List

With the updated delegated act on the MDR, the WET list for Class III and implantable devices has been expanded—but not every addition has led to greater clarity.

What we’ll be covering:

Manufacturers are now faced with key questions:

Which products have actually been newly added?
To what extent should key terms be interpreted in practice?
Where does a reasonable interpretation end—and where does regulatory risk begin?