If your company manufactures product - whether it's a medical device, a toy or a piece of electronic equipment - for sale within the European Economic Area, you'll need to go through the CE marking process.
CE (Conformité Européenne) marking demonstrates that your product meets European health, safety and environmental benchmarks - so it can be a long and complex route to approval.
The Qualsys services team share their tips to guide you through the process.
1. Understand who'll be taking part
Lots of businesses beginning the CE process spend time and money searching for and hiring notified bodies to conduct a conformity assessment. But not every company, depending on their category of product, actually requires an external assessor to get them over the line.
The European Commission's 'Blue Guide' spells out three scenarios: using an external body, involving an accredited in-house conformity assessment body, or no third-party involvement whatsoever. For the last option, a conformity declaration supported by the right technical documentation will be enough.
Don't jump at the first CE assessment body you find. You might not need one! Do your research before you begin.
- Caroline Wilson, Service Implementation Manager
2. Look after your Technical File
Whichever approval pathway you end up going down, your Technical File will be the core of the process. It contains all the information necessary for demonstrating that your product meets the requirements of the EU directives and required standards: product design, components, manufacturing specs and so on.
I implemented our document and change management software modules for one of our medical device customers to help them organise their CE process. Design controls and updates are managed with automated change management workflows and notifications to ensure nothing is missed, while all technical information is securely stored with version control in their electronic repository.
Their Technical File is highly complex as it focuses on a Class II medical device - but with some robust electronic processes and procedures in place, it's got them through to the European market.
- Dave Beard, Service Implementation Manager
3. Make it easy
At Qualsys we follow the values of PEOPLE: the 'E' stands for making things as easy as possible with collaboration and proper planning.
CE marking is exactly the same. Before you start, think how you can save your business time and money. Using components that already have CE approval in your product, for instance, will reduce the complexity and time expenditure of the approval process.
If your business is aiming for other certifications or markings, like GS, ENEC14, NEMKO, or even FDA 510(k), combine your initiatives. There can be significant overlap in the requirements, and if you do need an external certifying body they'll be able to sign you off for multiple approvals in one go.
Getting everything right from the start and getting input and suggestions from all relevant personnel - not just the quality team - will save you headaches down the road. Collaboration meetings, internal audits and document-sharing are all key.
Good luck!
- Mark Brook, Senior Service Implementation Manager
Next steps
Learn how York Instruments's quality manager tackled his CE marking process with Qualsys's solution by watching the interview video.
Need some more CE support? Book in a 15-minute discovery call with us and see how we can help.
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