+44 (0)1298 873800

Medical

£ 250.00 each

Self-Assessment Procedure for Class 1 Medical Devices V3 Includes 2 Hrs Consultancy

This downloadable pack contains the information required for you to understand the process of CE marking Class 1 Medical Devices.

£ 500.00 each

Own Brand Labelling for Medical Devices

To help you decide if this is the right product for you, please click here to download the flowchart "Am I an OBL?" With a few simple questions, you can clarify if you are taking on the role of an OBL or if instead, you are an importer, a distributor or an Authorised Representative.

£ 10.00 each

Draft Declaration of Conformity for Class I Medical Devices

This draft Declaration of Conformity is suitable for non-electrical Class I medical devices. It is an editable document and comes complete with detailed guidance notes.

£ 10.00 each

Draft Declaration of Conformity for Class I Medical Devices which contain Electrical Equipment

This draft Declaration of Conformity is suitable for Class I medical devices that contain electrical equipment and are therefore also within the scope of the Restriction of Hazardous Substances Directive (RoHS2).  

£ 25.00 each

Medical Devices Directive Classification Guide

Medical devices fall into one of four (Class I, Class IIa, Class IIb and Class III) categories depending on the level of risk.

£ 20.00 each

Technical File contents checklist for Medical Devices Directive

Technical file contents checklist for the Medical Devices Directive.

£ 130.00 each
£ 70.00 each
£ 25.00 each

Medical Device Directive Logos Package V3

This downloadable pack contains all the logos you will need to deliver information and Instruction to the user of your Medical Device. It also Contains checklists to help you identify the symbols you require.

 

£ 15.00 each

CE mark labels - 20.3 x 12.7mm

Self adhesive durable CE mark label, 20.3 x 12.7mm. Black on white background. Price per sheet (152 labels).

Results 1 - 10 of 11
Go To Top