MDR – a new regulation for medical devices is here

The new Medical Devices Regulation 2017/745 (MDR) came in to force on May 26, 2021, as a sound and transparent regulatory framework recognized worldwide. Applicable to all medical devices in European Union member states and Switzerland, it replaces the directives MDD 90/385/EEC and AIMD 93/42/EEC and imposes certain obligations on economic operators.

Cedic is ready with all our products now designed according to the new regulations. For existing products previously covered under the MDD and AIMD, we can work with our clients to recertify products in line with the new MDR requirements.

Feel free to contact us for specific information on the MDR as it relates to our products.

Introducing our Extension Sets for G-buttons

Cedic has launched a range of extension sets for the administration of enteral nutrition, fluids and/or medication via a low-profile gastrostomy feeding tube (G-button).

Suitable for bolus or continuous feeding, they come with either a straight patient side connector with large bore tubing or a right-angle connector with small bore tubing.

All options are available in multiple lengths, with or without clamp for user convenience and feature a single or double ENFit® twist lockable port to safely facilitate the administration of medication.

As with all ISO 80369-3 ENFit ports, these extension sets are designed to be IV incompatible to promote patient safety by helping to avoid accidental misconnections.

View them in our catalogue or contact us to request more information.