Certify your medical device in the EU & US

In the EU, medical device certification is a CE mark for your product. 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.

In the US, medical device certification means approval of your product by the US Food and Drug Administration (FDA). This can be as simple as registration of your device in the FDA database for Class I products, to 510(k) clearance for Class II devices, or PMA for Class III devices. In all cases, medical products like medical devices are under regulatory scrutiny of the FDA and need to satisfy the FDA requirements in order to be sold on the US market.

The certification process for medical devices is centered around meeting the regulatory requirements specified by the country you wish to certify your device in. Companies looking to certify their medical device in the EU (CE mark) or in the US (FDA approval / clearance) should typically go through the following steps: 

-determine their product risk class and regulatory requirements according to EU Medical Device Regulations (MDR) 2017/745 or US FDA 21 CFR,

-establish a Quality Management System under ISO 13485 for EU or 21 CFR Part 820 for US FDA,

-create your technical documentation for your device according to the standards relevant for your region,

-undergo an audit your quality management system and technical documentation (unless Class I in EU or 510(k) exempt in US),

-maintain post-market requirements for the device for surveillance and device changes.

Formly’s software helps you with all of these steps.

Formly covers all standards that are required to be met by your medical device in order to be on the US and/or EU market. 

Medical devices in the EU 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.

In the USA, medical devices must comply with FDA's 21 CFR requirements. The US recognizes many of the same international standards as the EU which makes preparing your medical device for certification in both markets simultaneously a good idea. Formly can ensure you'll be compliant in both.

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 certified faster and easier, our software can help. Our Document Autopilot generates MDR and FDA compliant documents for you and built in descriptions and video walk-throughs guide you through the rest.

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 certification 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.

Yes. See more in our blog post on the subject.

This all 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. Your development time for creating and testing your product will always depend on your company and product type. Generally, Class I software medical devices can take as little as days to months. Class II (IIa / IIb) medical devices can take months to years, and Class III devices take multiple years.

When it comes to reviewing your certification submission, in the EU, notified body audits often take anywhere from 3-18 months to complete for Class IIA, IIB and III products. In the US under the FDA, the review for 510(k)s take 30-90 days while Premarket Approval (PMA) can take up to 180 days. Typically, 510(k)s are for Class II products and PMAs are for Class III products.