Clinical testing

Do you need clinical data for your medical device before marketing?

Did the PMCF- report reveal that some indications are not sufficiently substantiated?

Then contact us.

We work as a CRO and/or perform various clinical trial functions. Our core competence is in the field of wound care and material medical devices. Other studies are possible by arrangement.

In the context of digitalization, we work with a cloud-based database from the company Climedo https://climedo.de

Depending on the product class, clinical trials have always been part of the conformity assessment process for medical devices.

Before the medical device is placed on the EU market, a clinical evaluation (CER) must be performed by the manufacturer. Clinical data are required for this. They must prove that the medical device is safe and capable of performing as claimed. If no data are available, clinical trials must be performed with the medical device. This is also called a clinical trial.

Types of clinical trials

The type of clinical trial that the manufacturer must select depends largely on whether the medical device is CE-marked, used within its intended purpose, or whether additional invasive or patient-impacting procedures are used.

There are three types of clinical trials to which the MDR requirements apply:

• Clinical trials for conformity assessment (type A) according to Art. 62 are subject to approval. Articles 62 to 81 and the requirements of Annex XV apply.
• Clinical trials in the context of Post-Market Clinical Follow-Up (PMCF, Type C) are not subject to approval, but are subject to notification. The requirements of Art. 74 (1) apply.
• Other clinical trials (type B) according to Art. 82 are neither subject to approval nor notification. There may be further requirements in the respective EU member state. The requirements of Art. 62 (2, 3, 4b/c/d/f/h/l and 6) apply.

All PMCF studies, with and without additional invasive or stressful procedures, conducted as part of the intended use of the device shall be reported in the PMCF Plan (Annex XIV, Part B, MDCG 2020-7).