The 2017/745 Medical Device Regulation which will replace Directive 93/42 / EEC has provided a period of time to allow a gradual transition to the new requirements. This transition period started last 26 May 2017 will end on May 26, 2020.
If today, on average, the approval processes of a medical device are about nine to twelve months, if we consider that near the next May 26, 2020 there will be fewer Notified Bodies but more Medical Devices, it is easy to make a calculation backwards and imagine to present a certification request according to the 2017/745 Regulation around May 2019, provided that the Notified Bodies are, in turn, ready.
Therefore, there remains little more than a year for Class I medical devices to be exploited to the fullest.
The requirements to be demonstrated for a class I medical device according to Directive 93/42 / EEC are certainly less extensive than those foreseen by the new regulation: the same device will be reclassified, in the case of devices based on substances, in class IIa or IIb or, why not, in class III. There will also be requirements that require manufacturers to investigate safety issues and confirm the mechanism of action.
So how to take advantage of this period?
First of all, we have all the necessary information and the necessary time for a collection of clinical data on the efficacy and safety of the device already valid on the market. The launch of a targeted surveillance plan can certainly be a low-cost investment. Starting immediately would allow manufacturers to have at least one year of data (if not more) at a low cost, with a value added inversely proportional to the cost and certainly necessary to meet some of the new essential requirements.
In addition, we also have the time necessary to invest in literature research before and after studies (whether in-vitro and / or in-vivo) to demonstrate the additional requirements on the mechanism of action and for the evaluation of of the case “and” where applicable “in the case of absorption.
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