Before medical device manufacturers can legally CE mark their products in Europe, they must comply with the medical device regulations set forth by the EU Commission.
It is vitally important to know the correct medical device classification for your product prior to CE marking your device. Improper classification can have a big impact on the regulatory requirements as well as the approval process and its associated costs.
Determining Your Device Classification for Europe
The first step in the European regulatory process is determining which directive applies to your product. Most devices fall under the Medical Devices Directive (MDD) 93/42/EEC but some high risk implantable products must follow the Active Implantable Medical Devices Directive 90/385/EEC. The In Vitro Diagnostic Directive 98/79/EC applies to IVDs.
Europe uses a rules based classification scheme for medical devices under the scope of the Medical Devices Directive. Those 18 rules can be found in Annex IX of the MDD. The European system stands in contrast to the US system which depends on finding similar devices (predicates) already approved by the FDA.
How Medical Devices are Segmented in Europe
Essentially, all devices fall into four basic categories:
- Non-invasive devices
- Invasive medical devices
- Active medical devices
- Special Rules (including contraceptive, disinfectant, and radiological diagnostic medical devices)
Devices are further segmented into the classes noted below. IVDs have their own classification scheme and while active implantable devices do not follow the same classification system as provided by the MDD, they are subject to similar requirements as Class III devices:
- Class I – Provided non-sterile or do not have a measuring function (low risk)
- Class I – Provided sterile and/or have a measuring function (low/medium risk)
- Class IIa (medium risk)
- Class IIb (medium/high risk)
- Class III (high risk)
Why choose Emergo to assist with medical device classification?
Emergo represents more than 1,000 medical device companies as an Authorized Representative in Europe, and we have helped countless manufacturers to obtain CE Marking.
- Our team specializes in medical device regulatory consulting and can help you determine the proper classification for your medical device or IVD.
- Our in-depth knowledge of European medical device regulations ensures that we can assist you in finding the most efficient regulatory approval strategy for your device.
- We can assist you preparing a Technical File or a Design Dossier that demonstrates compliance with the MDD, IVDD or AIMD.
- As your Authorized Representative, we can communicate with Competent Authorities on your behalf once your device has been approved.
Please contact us if you need assistance with medical device classification or regulatory strategy in Europe.