Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device, creating and maintaining a Clinical Evaluation Report (CER) can be a complex and resource intensive task.
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system that provides continuous feedback about a device on the market in order to maintain a high standard of product quality.
Are you thinking of marketing your medical device in Europe? If so, you must write and maintain a clinical evaluation report (CER) as part of your Technical File submission. The EU Directives emphasize the importance of the CER and include specific requirements for clinical evaluation review and documentation.
Interested in selling your medical device in Malaysia? General medical and IVD devices are regulated by the Medical Device Authority (MDA) of the Ministry of Health, and the regulatory process closely follows GHTF guidelines.
The FDA established a unique device identification system to identify medical devices through their distribution and use. It affects all medical device manufacturers and is being introduced in phases to allow time to change labeling, packaging, and internal documentation.