CE Mark and self-declaration: How do you prove your product meets conformity requirements?
During the CE marking process, it is an important requirement to prepare and maintain a technical file for the product in question and showing evidence of conformity. What a technical file should detail: -Product Development -The decisions made regarding the product -Product progression: concept to final design The essential requirements of a technical file can be located in the Annex of the product Directive. What makes up a technical file? -An overall overview of the product and a general description of application/functions. -Clear diagrams of circuits, BOM’s and construction drawings that include any calculations, test results performed in the product development stage. -Any risk assessments that have been performed and risks identified with corrective actions that mitigate any hazardous events – justifications of hazards cannot be reduced. -The list of standards and directive that have been applied as part of the conformity assessment process. -Copies of technical reports, e.g. EMC and product safety. -A copy of user and installation instructions to ensure the safe use of the product. -A signed copy of the Manufacturer’s Declaration of Conformity. Who needs to see the technical file? Your technical file MUST be made readily available to all relevant authorities of the Member States for at least 10 years after the last manufactured date. At Cranage EMC & Safety, we have assisted with many Manufacturers, Importers and Distributors (EU & Non-EU) with the technical file requirements and have a range of services to meet your needs, such as: -Help to prepare for a technical file. -A technical file review. -Preparation assistance of a Declaration of Conformity for the Manufacturers to sign. FREQUENTLY ASKED QUESTIONS: Q: Why do I need a technical file? A: As an EU Manufacturer, you or an appointed authorised representative must compile a technical file for each product that is placed on the market. This is a legal requirement and is determined by the relevant European Product Directive. It is imperative that you demonstrate how your product complies with all relevant Directives, this can be demonstrated with documentation, calculations, risk assessments, drawings, and test reports. Bear in mind this is not just as a new product, it must be compliant and safe throughout operational life within all specified environmental conditions – our experience in reviewing such documents for Manufacturers has highlighted this is normally a shortfall when compiling a technical file. Q: Who needs to see my technical file? A: The EU Manufacturer (or appointed authorised representative) must be able to provide the technical file to any European Market Surveillance Authority, upon request and within a reasonable timeframe. Refusal or failure to do so may result in the MSA to completely remove your product from the market until you prove compliance within the required Directive accordingly. Get in touch to find out more about our technical file reviewing service and how we can assist you: firstname.lastname@example.org | email@example.com | 01630 658568
Med-Tech gives us the opportunity to show and discuss the types of services that Boddingtons Plastics can offer to our customers. We've seen really good footfall and had several new leads for new devices. The show has been a great success for us and in fact we've booked for next year already.
MedTech Innovation Expo was a fascinating event that gave us new insight and inspiration into the challenges we face and, more importantly, into the solutions to solve those challenges. We’ve already marked the event on our calendar for next year and we can’t wait to see what progress has been made… and perhaps, more importantly, what progress we can aid with our Aether Engine technology!
It was great to speak at this excellent event, very well attended by the NHS and Industry, well organised and plenty of opportunities for networking. Looking forward to coming again next year!
We’ve managed to get a lot of interest of people... It’s a lot bigger than what we expected, and we’ve managed to find unexpected partnerships with companies we didn’t even know existed. We were here last year but we weren’t exhibiting, and we were impressed with the quality and quantity of exhibitors, so we thought it was worth it this year.