A clinical evaluation is an integral part of the registration of medical devices. The clinical evaluation report ensures that Medical Devices perform as intended within their clinical use and are as safe as practically possible before and after they are placed on the market.
In the EU (European Union) for the purposes of CE marking and UK (United Kingdom) for the purposes of UKCA marking all medical devices irrespective of type are required to have a Clinical Evaluation. The data generated from the Clinical Evaluation are evidenced in a Clinical Evaluation Plan (CEP) and a Clinical Evaluation Report (CER).
In the UK the Clinical Evaluation needs to cover the requirements of Annex X of the Medical Device Directive 93/42/EEC (MDD clinical evaluation) under the UK Medical Device Regulations 2002 (as amended).
Within the EU the Clinical Evaluation needs to cover the requirements of Article 61 and Annex XIV of Medical Device Regulation EU 2017/745.
The difference between Clinical Investigation & Clinical Evaluation
There is often confusion between Clinical Evaluation and Clinical Investigations (Clinical Trials). Medical Devices that are established on the marketplace or have an established clinical use often do not require a clinical investigation. This is because there is already clinical data to support the safety of the medical device being placed on the market. An example would be wheelchairs, infusion administration sets or infusion pumps.
Clinical Investigations would normally be carried out on medical devices where there is a new clinical intended use that is novel, and there is no clinical history to support its safe use, or the device is being used for a clinical purpose that is not within its normal intended use.
What is needed in a Clinical Evaluation?
A Clinical Evaluation is a review of all of the data that has been generated in terms of;
- Product verification and validation activities (proving the design of the device works and performs as intended).
- Biological Evaluation (if a patient contacting device).
- Risk Management activities (ISO 14971).
- Any preclinical studies.
- Clinical literature review looking at the relevance of any clinical studies that can verify that clinical use of the device is proven based on similar devices placed on the market and/or inclusion of any clinical investigation carried out on the device.
- Post Market Surveillance relevant to the device and any Post Market Clinical Follow up data to support the devices on going history of clinical safety.
A medical device clinical evaluation report needs to be updated on a regular basis, for example, every 2 years or sooner for more complex devices that may be of higher risk.
We can support you with technical files for CE marking, which are required for medical devices on the EU market. Alternatively, we can provide help with UKCA markings for devices being sold on the UK market.
How can we help?
Clinical Evaluation needs to be carried out by professionals who are qualified to perform clinical reviews in a medical discipline relevant to the clinical use of the device.
Patient Guard can support you with creating an MDR Clinical Evaluation Plan and MDR Clinical Evaluation Reports. We can also provide assistance with updating your Clinical Evaluation Plans and Reports. Please contact us if you would like to discuss your Clinical Evaluation needs.