A clinical evaluation provides clinical evidence that the medical device performs as claimed by the manufacturer and that it is safe to be used in clinical setting. Sometimes, especially when clinical investigation is needed, the clinical evaluation requires collaboration with healthcare institutions.
What does clinical evaluation entail?
What a clinical evaluation entails is recorded in Article 61 of the MDR. Three components are required in the evaluation:
- assessment of clinical performance and safety of the device using relevant scientific literature;
- available data from clinical studies already conducted; and
- available alternative treatment options for the intended purpose.
Clinical investigations are required only for Class IIB and Class III; for the other classes, they are not required by law, if the manufacturer provided sufficient evidence based on other sources. For more novel techniques, however, clinical trials may be necessary because there is less chance of existing clinical trials. For clinical investigations with a medical devices the MDR directly refers to Good Clinical Practice (GCP) according to ISO. So, it is highly recommendable to use this standard to comply with the MDR’s requirements for clinical investigations.
Any investigation of a medical device according to an article under the MDR must be authorized by the government (State Members). In the Netherlands, supervision is carried out by the Centrale Commissie Mensgebonden Onderzoek (CCMO) and permission must be obtained from medical ethics review committees (METc’s). What the requirements are for submission to a METc (standard research file) depends on the MDR article that’s applicable[1].
Note that hospitals may have their own requirements for the trial separate from the METc. With in-house development, this approval is usually obtained before the METc review; with an external manufacturer for clinical trials, it is the other way around.
Good to realize is that an investigation with a medical device can have two different goals: to be part of a Clinical Evaluation Plan (CEP) according to the MDR or to add scientific value by publishing in journals. A study can have both goals, but it does not have to. To gather evidence under the MDR, you don’t necessarily have to publish, but you do have to comply with the MDR.
How do I contact a healthcare institution?
Even if a new medical device is fantastic, this does not mean that all hospitals will want to collaborate with the manufacturer immediately. More is needed for a good collaboration, such as: the research must fit within the hospital’s vision and mission, future plans and availability of a relevant research group.
Through a central coordinating point within healthcare institutions, manufacturers have the greatest chance of finding a collaboration that bears fruit. Conferences offer opportunities to engage directly with healthcare organizations. If you already have a contact lead, it is still recommended to contact a central point for efficient affiliation with the organization. UMCs (and possibly top clinical hospitals) may additionally be able to help with drafting research contracts, referral to technical entry approvals and other internal approvals, joint finding of grants and other resources needed to realize development/innovation.
Here are some hints stated for central coordinating points for innovation within hospitals:
- UMC Groningen: Innovation Center (umcgresearch.org).
- Martiniziekenhuis Groningen: MartiniLab (martiniziekenhuis.nl)
- ISALA Zwolle: ISALA Innovatieloket
- Medisch Centrum Leeuwarden: MCL Academie
- Other UMCs and (top clinical) healthcare institutions can usually also be contacted at a central point: search the internet for “the name of the healthcare institution” and “innovation”.
[1] For information Standard research file medical devices | Investigators | The Central Committee on Research Involving Human Subjects (ccmo.nl)
