From what I learned during the lecture, I think it is easier for a medical device to be approved. The directives does not give you a “one size fits all approach” instead there are many ways,the conformity assessment route, in which not all articles in the directive apply to the device and there are different route choices that can be applied to demonstrate compliance to the MDD and the essential requirements.Thus giving a fastest route for approval and CE marking or even a route that is cost effective that will also get approved.
Also the classification of the product is easier, the EU classifies medical device based on risk only and the essential requirements check list helps determine classification. Also, clinical data requirements, as specified by tn58, for CE marking arises from the requirement to demonstrate that a device is safe, that it performs as intended, and that risks are acceptable when weighed against the benefits of the device. For low to medium risk devices, clinical data can be presented as a compilation of relevant scientific literature available on the intended purpose of the device and the techniques employed that can demonstrate safety and performance. For high risk devices, clinical trials are required but it does not required a prospective, randomized controlled, adequately powered clinical trials involving hundreds of patients like the FDA requires, so long the device demonstrate safety and it performs in a manner consistent with the intended use. Resulting in less time and money spent for a CE mark in order to put the device to the market.
Another big plus that EU regulation offers is the fact that if something is changed to the tech file, it must be reported to the Notified Body and if they think is something of concern they request the tech file, but the company can still start selling the device on the market compared to the FDA that if something changes, a whole new 510K or PMA supplement must be submitted which may need new clinical trials and the device cannot be sell in the market.