1. Why did the NBs accept subpar CER submissions in the past?
Simply put, and for reasons not completely known, NBs were not enforcing the content and format of lower risk product CERs. The authorities overseeing the NBs are now requiring that their NBs ensure all medical devices in the European market wanting to receive or retain a CE mark have a compliant CER.
2. Why is the push for stricter compliance occurring now?
ISO 14971 (Medical devices—Application of risk management to medical devices) underwent a major revision in 2012 and became a European Norm (EN). An EN is a law in Europe, which means it must be followed. An EN ISO is more enforceable than an ISO. The risk management changes in EN ISO 14971:2012, based on the Medical Device Directive (MDD), are also reflective on the clinical risk evaluations required in the CER. EN ISO 14971:2012 has given CERs more visibility. The EN ISO 14971:2012 standard may be purchased at www.iso.org
, or from any organization licensed to sell the standard.
Companies might have two different challenges:
A risk management process that, according to EN ISO 14971:2012, is not meeting the standard
A CER that is not meeting the directive, which is evaluated by the MEDDEV document
3. Why the urgency around CER submissions?
Many companies that received their CE mark certification before 2012 have begun submitting revised CERs as part of the five-year review cycle for their products. They have been surprised to find their NBs are rejecting their submissions due to noncompliance with MEDDEV guidance, even though past submissions had been accepted. Without a compliant CER, the CE mark for a product can be delayed and even withdrawn, resulting in a company no longer being able to sell that product in Europe (or any member states of the European Union).
4. What can my company do now?
A. Obtain and review the relevant CER guidance, and make sure it is completely understood. If there are any questions, seek assistance from an expert.
B. Conduct a gap analysis to determine whether or not your CER meets the requirements of the MEDDEV.
C. Identify any noncompliant issues.
D. Fix those issues to bring the CER into compliance with the MEDDEV. If an existing CER is highly noncompliant, writing a new CER may be preferable to amending the existing CER.
E. Create a standard operating procedure on how to write CERs, or update the existing one, and include a template in the appendices.