CE marking Operating tables

Operating tables are tables on which patients lie during surgeries. These can be standing or mobile and C-arm compatible or other diagnostic systems compatible too.

As a first step for CE marking the Medical Device Manufacturers need to determine the classification as per MDD 93/42/EEC annex IX and determine the harmonized standards that apply to the product. These Operating tables are generally Class I.

Though, these are self-Certified devices and do not need the intervention of a notified body, the Medical device manufacturer can get in touch with a competent body to issue a compliance certificate, that can be showcased to customers as a symbol of safety and effectiveness of the device. It is the duty of the Manufacturer to maintain a technical file in their records.

The Technical File for CE marking the Medical Device must consist of the following important documentation for operating tables:

· Essential Requirements checklist

· Classification rationale

· Drawings and other design documents.

· Declaration of Conformity

· Risk Management file as per ISO 14971

· Biocompatibility

· Compliance to harmonized standards

· Clinical Evaluation report if needed or a justification can be enclosed.

· Safety test reports where relevant

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jr@i3cglobal.com