Medical Device Directive or CE Marking for Medical Devices

In order to sell medical devices in Europe, the manufacturer must obtain a CE mark. Basically this means they must prove their device is safe and effective. This is also true of in-vitro medical devices and active implantable medical devices which have their own separate legislative directive, but which basically follow the same rules.

European government recognizes that less risky devices should be able to be demonstrated in a less comprehensive and thus less costly way, versus more risky devices. So like the FDA in the US, they have categorized devices according to that risk, into different medical device classifications. The least risky Class 1 has fewer requirements to address and no audit/review is required. The most risky Class 3 (middle classes are 2a and 2b) has more requirements including comprehensive product master file and design review and independent auditing of management system requirements.

MDD compliance starts with getting certified in ISO 13485. While it is not mandatory in the legislation, it is the accepted solution to the quality management requirements that are in the legislation. If you get ISO 13485, audited by an “approved” certification body (known as a Notified Body) then it is illegal for anyone to challenge you, because you have met this part of the legislation.

Next the legislation requires additional management system controls such as post market surveillance, vigilance and reporting among others. There are also some technical parts of the legislation that it just makes sense to design a process to ensure it is achieved and thus these become part of the management system.

The technical requirements of the legislation require you to put together comprehensive records for your product including clinical and other testing, For instance if your device includes electronics or electrical components then you need testing reports to prove stability for radiated and conducted interference. Risk assessments on the device (and some production processes) are necessary and detailed evidence must be put together to support conformance to the requirements in the legislation (known as the Essential Requirements.) There is an expectation that if international or national standards exist for your product or relevant processes e.g. sterilization, toxicity testing, etc. that these will be followed. You can argue against some standards (after all the legislation didn’t make them mandatory) except those formally “harmonized” which means its impossible to argue.

Finally it is important to note that while say, FDA and CE marking are separate, they both basically demand the same thing. The approach to demonstrating it should be one system, one way of doing things and one set of records (wherever possible). Some separate evidence is necessary (e.g. ISO 13485 versus CFR21 Pt. 820) and sometimes duplication to present it differently to a different agency, but substantially one system.