CE Marking in the medical sector indicates that healthcare appliances – meet legislative requirements in full.
The certification that supports the CE Mark is ISO 13485. Like certification in other industries, it is based on ISO 9001 but adds sector-specific elements to prove compliance and provide certainty in the medical world.
Registered CE marks are a legal requirement for the sale of many medical devices within the European Union, but other countries outside the EU also formally recognise the marking system.
To place a CE mark on your product, you’ll need to:
CE compliance recognises that feedback and improvements will continuously be fed into systems, as well as facilitating harmonised regulatory requirements for medical devices.
As standards work in tandem with relevant regulations but are not in themselves written into law, CE mark requirements will only work as an effective process if manufacturers of medical equipment understand when it’s necessary to apply for and include a CE mark on their product.
Our Qualitators can help you understand the requirement for a CE mark and advise you about the process of achieving it. We assist with creation of registration documents, collaborate on technical information and requirements, and correct formatting of the application to save time and money. While we never assume we know more about your products than you do, our Qualitators have had a great deal of repeated experience gaining the CE Mark and the ISO 13485 standard for a wide range of medical devices.
The advantages of having ISO certification relating to CE marking include the fact your customers will recognise your compliance to a global industry standard. This has been particularly important within the EU, with companies operating across borders into other member states finding the process of approval for their appliances to be considerably shorter and technically less difficult than they might have been if CE certification did not exist.Going forwards, we do not anticipate Brexit changing this set up.