Menu Close

What are the main differences between FDA and EU medical device classification?

What are the main differences between FDA and EU medical device classification?

The FDA approval process mandates that a device be proved efficacious compared with a control or be substantially equivalent to a predicate device, whereas the European Union approval process mandates that the device perform its intended function. Stringent, peer-reviewed safety data have not been reported.

How many classes are medical devices placed under EU regulations?

There are three main classifications for medical devices: Class I, Class II, and Class III. In addition, there are sub-classes such as, for example, Class IIb and Class IIa.

What is a difference between the US and EU classification?

The FDA historically developed as a consumer protection agency, whereas the regulations from the European Commission arose out of a need to harmonize inter-state commercial interests while preserving national “autonomy.” Thus, whereas the FDA has the advantages of centralization and common rules, the European Union …

Is EMA better than FDA?

The study also found EMA had a higher rate of first-cycle approvals than FDA, and the researchers “observed remarkable similarity in the basic scientific and data interpretation issues raised by the FDA and the EMA during reviews of the same applications.

What is the EU medical device classification?

EU Medical Device Classification. Under the EU Directives, the classification of medical device, is based on 4 classes as follows: » Class I – low risk » Class IIa – medium risk

What are the different classifications of medical devices?

According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. The medical devices of Class III hold the highest risk.

Does your medical device comply with the European Directive (MDD)?

If you are a manufacturer and you want to place your medical device on the EU market, you need to make sure it complies with the specific European Directives set forth by the European Commission. In that case, of importance are the Medical Device Directives (MDD): AIMDD 90/385/EEC; MDD 93/42/EEC; IVDMDD 98/79/EC.

What is a Class 1 medical device?

Class I Medical Devices. Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g.,

Posted in Blog