Class 1 Device Requires Clinical Evaluation Report (CER) too!
Article explains how to write a clinical evaluation report (CER) for CE Marking Class 1 medical devices when there is little or no clinical study literature available. The history behind this European CE Marking regulatory requirement is explained as well.
In 2010 the European Medical Device Directive was updated to include many tougher regulatory requirements for medical devices of all types. One of this changes is criticized frequently by industry–the change to make essential requirement 14 to a general requirement for all devices. That requirement is now essential requirement 6a in Annex I of the current MDD (93/42/EEC as modified by 2007/47/EC). The general requirements are required for all devices–event products that do not require a Notified Body’s involvement.
Typical Search Strategy for a Class 1 Device
Class 1 devices do not typically have clinical studies performed for three reasons:
- the products are low in risk and therefore do not require clinical studies for regulatory approval
- the products have been on the market for a long time and therefore there is little innovation in these products
- clinical investigators are not interested in researching devices that have been used for a long time
Since there is typically no requirement for a clinical study for a Class 1 device, companies will perform a literature search in order to meet the requirements of Essential Requirement 6a. That search will typically result in articles that mention the device or a competitor device, but the device is typically just part of a clinical study that was performed for another device (i.e., the device of interest is merely an accessory). If there are clinical studies, the studies may be quite old and it may be more helpful to search for review articles first. In the end, you may end up finding no clinical studies for the type of device you are designing, but a clinical evaluation report is still required for CE Marking for Class 1 devices.
It may be painful for you and your company to conduct a clinical evaluation, even using the literature route, when there are no new clinical studies to find. However, the CE Marking regulations are written to address all devices and material innovations alone are driving the need for companies to reconsider the “state of the art” for even Class 1 devices. It is also important to consider emerging issues such as infection control with antibiotic resistant strains and the trend toward using disposable instruments such as drill bits.
Reference Articles for Clinical Evaluation Reports and PMS
I have published 3 previous blogs specifically on the topic of clinical studies and post-market surveillance over the past couple of years. Please click here if you are looking for more information on this topic.
Procedure/Template for Class 1 Device Clinical Evaluation Report (CER)
If you are looking for a procedure (SOP) and associated literature search protocol template for a clinical evaluation report (CER) please click here. The purpose of this 6-page procedure is to define the process for performing a clinical evaluation of literature in accordance with MEDDEV 2.7/1. There is also template provided for performing a literature search (i.e., TMP-004).