Request access today to get an early adopter discount and free expert guidance.
Flexible packages tailored to you.
Frequently Asked Questions
What is a CE mark and why is it important for my business?
CE is an abbreviation of "conformité européenne" which equates to European conformity. CE marking indicates that a product has been assessed and deemed to meet EU safety, health and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU. CE marking is especially important for medical devices which must meet a high regulatory standard before being allowed on the market.
What is the CE marking process for medical devices?
The CE marking process for medical devices is centered around meeting the regulatory requirements in the EU region. Companies looking to CE mark their product should typically go through the following steps
-determine their product risk class and regulatory requirements according to EU Medical Device Regulations (MDR) 2017/745,
-establish a Quality Management System to develop your product while creating the required technical documentation,
-undergo a conformity assessment audit from a notified body for your quality management system and technical documentation (unless Class I self-certify),
-finalize their Declaration of Conformity, affix the CE mark, and maintain post-market surveillance requirements.
Formly’s software helps you with all of these steps.
What are the regulatory requirements for CE marking and does FormlyAI cover them for my device?
Formly covers all standards that are required to be met by your medical device in order to be on the EU market.
Medical devices must comply with the EU Medical Device Regulations 2017/745, also known as MDR, first and foremost. Most manufacturers also use other international standards to ensure they meet all aspects of MDR. Some of these include ISO 13485, ISO 14971, IEC 62366, IEC 62304, and more depending on what type of medical device you have.
I don't know anything about medical device regulations. Is Formly right for me?
Yes! Formly’s software is built for everyone. If you are unfamiliar with the medical device regulations or wishing to improve your workflow efficiency to get CE marked faster and easier, our software can help. Our Document Autopilot generates MDR compliant documents for you and built in descriptions and video walk-throughs guide you through the rest.
When should I start to work on certification? Can I start too early on this?
You can’t be too early but you can be late. Once you understand what product you want to build, you can start your certification journey. The regulatory processes and records created while preparing for your CE mark integrate with product design, development, and testing. By starting your certification procedures early, you integrate quality processes into your workflow and avoid having to repeat steps down the road.
Can my product be Class I now and then be Class IIA later?
How long does it take to get my CE mark?
It depends on your medical device. Class III devices have more extensive regulatory requirements than Class I devices and often take longer to prepare for market entry. Also, notified body audits often take anywhere from 3-12 months to occur. As such, Class I software medical devices can take as little as days to months and Class IIA hardware medical devices can take months to years.