CE Marking - Medical Devices

Class 1 devices

Although the requirements are relatively straightforward, CE marking for low risk medical devices can still provide a number of headaches for small businesses, we have helped in a variety of ways including,  

• Providing a complete service from initial assessments through to advise on MHRA registration 
• General guidance and assistance 
• Preparation of templates for assessments of multiple products 
• On-site training of staff 

Higher Class devices

The compliance requirements are more complex for Class 1 devices that are Sterile or have a measuring function and for all higher Class devices. One requirement is to show that the "manufacturer" has an "appropriate Quality system in place. One way of demonstrating that a suitable system is in place is to ensure that it complies with the requirements of ISO 13485. We have provided advice and assistance for Class 1 sterile and Class IIa devices such as dental laser systems, airway devices and fluid warming oven.  These projects have included the following,

• Advice concerning the process and applicable directives 
• Initial reviews of documentation and records 
• Detailed help with putting together a quality system that complies with ISO 13485 
• Provision of "internal" audits 
• Review of all detailed technical documentation or production of such technical documentation 

• On-site reviews
• Document production
• Remedial actions
• Complete solutions