Preclinical services

1MED provides support in defining the proper preclinical pathway.

We can provide support for preclinical testing assessing your medical device’ safety and performance thanks to our strategic partnership with 1LAB.

1LAB is a preclinical laboratory specialized in in vitro testing that can develop ad-hoc experimental protocols for your medical device, matching your specific needs.
1LAB is also specialized in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin and mucosa.

Do you have a medical device composed of substances or combination of substances?

When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21 and the requirement for new verification tests on medical devices composed of substances or combination of substances. If such devices are introduced in the human body, and are absorbed by or locally dispersed in it, these should be evaluated for absorption, distribution, metabolism and excretion (ADME), as required by the applicable conformity assessment procedure under MDR.

1MED can help you establish the need for such verification studies to be performed according to Directive 2001/83/EC.
Through 1MED’s partnership with 1LAB, we can also perform screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.), in order to investigate potential for local and systemic absorption, helping you saving time and budget.

Preclinical services

1MED provides support in defining the proper preclinical pathway.

We can provide support for preclinical testing assessing your medical device’ safety and performance thanks to our strategic partnership with 1LAB.

1LAB is a preclinical laboratory specialized in in vitro testing that can develop ad-hoc experimental protocols for your medical device, matching your specific needs.
1LAB is also specialized in advanced preclinical testing, using biomaterial scaffolding and tissue engineering technology to replicate human vessels, skin and mucosa.

Do you have a medical device composed of substances or combination of substances?

When it comes to MDR compliance, one of the major changes compared to previous legislation is the introduction of classification Rule 21 and the requirement for new verification tests on medical devices composed of substances or combination of substances. If such devices are introduced in the human body, and are absorbed by or locally dispersed in it, these should be evaluated for absorption, distribution, metabolism and excretion (ADME), as required by the applicable conformity assessment procedure under MDR.

1MED can help you establish the need for such verification studies to be performed according to Directive 2001/83/EC.
Through 1MED’s partnership with 1LAB, we can also perform screening in vitro permeation tests on several substrates (e.g. skin, cornea, vaginal mucosa, etc.), in order to investigate potential for local and systemic absorption, helping you saving time and budget.

REGULATION (EU) 2017/745

REGULATION (EU) 2017/745