Browse by topic
Subscribe to our news

MDR

Using Chemical Characterization to Achieve Biological Equivalence

In the EU, a device is considered to be equivalent if and only if it fulfills all the requirements of technical, clinical, and biological equivalence. Of these, biological equivalence tends to be the most nuanced and can be a confusing topic for medical device manufacturers—especially since regulators in different global regions don’t always take the same approach. Chemical characterization, which tends to get ignored—but is now a requirement per MDR, Annex II, section 6.1(b)—can help make claiming biological equivalence more feasible when “similarities/differences” exist.
Read Now
1

We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!