Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who market products in the European Union and seek to obtain or maintain a CE mark. It is needed for compliance with essential requirements in both the MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive) and is an important part in transitioning to the new MDR (Medical Device Regulations). The European Commission provides a guidance document, MEDDEV 2.7/1, that discusses the clinical evaluation process and was recently updated from version 3 to 4 in June 2016. The MEDDEV guidance is written for the industry as a whole, but remember, it is not legally binding, and the application of its recommendations can vary depending on the specific device and company. Every company and every device is different. Devices can span the range from low risk to high risk, from clear benefit to less clear benefit, and can be manufactured and sold by companies of all different sizes. Globiox consultants can leverage their experience from working with a variety of companies and devices in order to properly apply the guidance and to scale our clinical evaluation support for clients appropriately. Some factors we consider include:
- Client In House Expertise: a smaller company may need more outside expertise for the evaluation, while a larger company may only need a technical writer to compile information.
- Risk Level of the Device: A lower risk device with a clear benefit may require a different set of data as compared to a high-risk device, or a device with less clear benefits.
- Suitability of Existing Data: some companies may already have all the data they need, while others may need assistance in generating and locating more data.
Keeping these and other aspects in mind allows Globiox to control costs while supporting a client’s clinical evaluation so that the project outcome is a clinical evaluation suitable for their device, at a reasonable cost.
We work with clients before starting the clinical evaluation to understand where they specifically need help, and how best to apply the MEDDEV guidance to their device. Then, we will continue to collaborate with clients throughout the clinical evaluation process. This will ensure that they pay only for the specific support they need for their device and situation and have a thorough understanding of the end result.