Clinical Evaluation Reports (CER) under the EU MDR

MDS Finland is committed to ensuring the highest standards in clinical evaluation reports (CER) for medical devices. In response to the more stringent requirements of the Medical Device Regulation (MDR) 2017/745, our approach to clinical evaluations has evolved to meet these new challenges.

Our Comprehensive CER Services

In-Depth Clinical Evaluations

We conduct thorough clinical evaluations of medical devices. This includes a comprehensive review of clinical data, whether from clinical investigations of your device or studies on substantially equivalent devices.

Adherence to MDR Standards

We ensure that our CERs are fully compliant with the MDR requirements. The MDR mandates a detailed approach to clinical evaluations, focusing on specific General Safety and Performance Requirements (GSPRs).

Continuous Updating

Recognizing the dynamic nature of medical device regulation, we continuously update the CERs. This includes integrating new clinical data, post-market surveillance outcomes, and any modifications to the device.

Gap Analysis

We perform gap analyses on existing CERs to identify potential deficiencies and ensure that your documentation aligns with the current regulatory expectations.

Risk-Benefit Analysis

Our evaluations include a detailed risk-benefit analysis, assessing the medical device’s safety and efficacy in the context of its intended patient population and clinical setting.

Detailed Clinical Evidence Compilation

Our team compiles and critically analyzes clinical evidence, ensuring a comprehensive understanding of the device’s performance and safety profile.

Expert Team Involvement

Our experts are equipped with knowledge in medical device evaluation, clinical research, and regulatory affairs, ensuring the accuracy and validation of the CER.

Why Choose MDS Finland for Your CER Needs?

Expertise in MDR Compliance

Our team is well-versed in the new MDR guidelines, providing you with CERs that not only meet regulatory requirements but also contribute to patient safety and medical innovation.

Tailored Evaluations

We understand that each medical device is unique. Our evaluations are tailored to the specific characteristics and intended use of your device.

Proactive Approach

We anticipate the evolving nature of medical device regulations and keep our clients ahead in compliance. 

At MDS Finland, our mission is to support the development and maintenance of safe and effective medical devices. Through our detailed and compliant CERs, we contribute to the successful market entry of medical devices and uphold the highest standards of patient safety and care.