Clinical Evaluation

With us for clinical evaluation of medical devices under the Medical Device Regulation (MDR)

For all medical devices under the European Medical Device Regulation (MDR), evidence of safety, performance, and clinical benefit must be provided. The clinical evaluation of medical devices serves this purpose. If there is no existing robust literature data, a clinical trial must be conducted.

If robust literature data (compliant with Medical Device Regulation Group [MDCG] Guideline 2020-16) does not exist, data from market surveillance or new in vitro/in vivo data must be collected. If this is still not sufficient, a clinical trial for the medical device must be conducted. For this purpose, the qualified head of the clinical trial (investigator) prepares a dedicated protocol according to DIN EN ISO 14155:2011. According to Section 22a of the German Medical Devices Act (MPG), approval must be obtained from the competent higher federal authority (in Germany, the Federal Institute for Drugs and Medical Devices [BfArM]), and the consenting assessment of the competent ethics committee according to Section 20 (1) MPG. Likewise, the Ordinance on Clinical Trials of Medical Devices (MPKPV) and the Medical Devices Safety Plan Ordinance (MPSV) must be observed.

Requirements for a clinical trial of medical devices and implementation

The quality requirements for clinical trials of medical devices according to the EN ISO 14155 standard are quite comparable to those that apply to drug studies (International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use [ICH-GCP]). The steps of the clinical trial (according to Medial Devices Documents (MEDDEV) 2.7-1 Revision 4) include the preparation of the clinical evaluation plan (CEP; MDR, Annex XIV, Part A) and the clinical evaluation report (CER; MDR, Article 61). The conduct of the clinical study includes study design, study submission and registration, study conduct, safety reporting, audits, supplier qualification, clinical data management, and data analysis.

The study design must specify the type of clinical trial (e.g., superiority, non-inferiority, or equivalence), sample size, and statistical analysis plan (SAP). Also, the clinical investigation plan(CIP), Investigator’s Brochure (IB),clinical trial site selection, and electronic Case Report Form (eCRF) architecture and Trial Master File (TMF) structure must be determined. Submission of theclinical trial application (CTA)and its registrationis then made to the relevant national authorities, ethics committees and Notified Bodies.

Key steps in the clinical evaluation of medical devices are safety reporting (Serious Adverse Event, Reporting and Periodic Safety Reporting), audits, e.g., audits of the trial site, clinical procedures, contracted contract research organization / Clinical Research Organization, and supplier qualifications.

Clinical Data Management / Analysis (DCM Plan Compliation, Database Set-up, Clinical Set-up, Clinical Data Analysis, Clinical Investigation Report [CIR] Compilation and eCRF Solution) must also be implemented according to guidelines. The clinical evaluation for medical devices also requires cytotoxicity testing (evaluation of biocompatibility) according to DIN EN ISO 10933-3. Here, too, we support you with our network of testing laboratories.

We are happy to support you from the literature evaluation to the implementation of a comprehensive clinical study. Just contact us!