MEDDEV/MDR

Clinical Evaluation Report creation at its best to meet newest regulations from former Medical Device Directive to the newly introduced Medical Device Regulation and In Vitro Diagnostics Regulation. We will guide you through everything just like that!

Introducing medical devices in the European market requires the production and maintenance of a Clinical Evaluation Report (CER) that complies with MEDDEV 2.7.1 revision 4 and the newly introduced medical device regulation MDR substituting 93/42/EWG Medical Device Directive (MDD) and 90/385/EWG Active Implantable Medical Devices (AIMD). Your Clinical Evaluation Report documents the assessment and analysis of clinical data pertaining to your medical device to verify the clinical safety and efficacy of the device.

Clinical evaluation reports are an important step to CE Branding. Many manufacturers struggle to comply with European CER requirements –  DEMEDs has profound experience with Europe’s regulatory actions and the expertise in clinical literature reviews to help you prepare a CER that meets the regulations.

Clinical Evaluation Report (CER) for medical devices

A fully compliant Clinical Evaluation Report should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to known and unknown risk. The Clinical Evaluation Report must be based on clinical data, which may include data from literature, common expertise , trials, or their combination.

Requirement is to submit a Clinical Evaluation Report along with a technical fact sheet as part of the CE conformity assessment process. Never the less approach to the CER is as a solemn document.

We are CER

DEMEDs consists of specialists in the field providing the knowledge to ensure your CER meets all European requirements.

Consulting is our expertise

Future strategy, post marketing surveillance and studies, risk evaluation and final distribution, we are the solution to your specified needs.

Partnership is our success

We have successfully collaborated with notified bodies with notable scope according to NANDO database, which makes us the perfect partner for your future MDR/IVDR certification.