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Are you really ready for the Regulation?


With the increasing requirements to obtain the MDR conformity, much more than for the MDD as well as the reduction in the number of Notified Bodies that can release certificates according to the Regulation, the certification process for MDs is becoming longer for manufacturer.

Currently, as of the positive outcome of the Completeness Check, i.e. the “preliminary” evaluation by the NO, the actual release of the MDR certificate takes from 12 months (for low-risk devices) to 24 months (for high-risk devices). 

And that’s not all: at least 50% of the submitted technical dossier are considered incomplete and Notified Bodies require further data and information to achieve conformity.

As much as the time extension of March 2023 (Regulation EU 2023/607) has prolonged the period of presence on the market of legacy devices not yet compliant with the MDR, this is a time expansion useful to Notified Bodies to manage the certification requests and avoid the well-known bottleneck.

The lack of designated NBs is in fact a critical obstacle for the certification of new medical devices (and for the re-certification of existing devices originally certified according to the old regulations). This means that those MDs whose manufactures cannot find a notified body, shall be necessarily withdrawn from the market at the end of the transitory period or, in case of new MDs, their arrival on the market will be very much delayed, to the detriment of the company (that has certainly invested a lot in the development of the new product).

Considering this timetable, one cannot afford to wait for the initial feedback of the Notified Body to discover the lacks in the relevant Technical Documentation. It is essential to be prepared in advance and have picture of the starting point as clearer as possible.

Our medical device team has developed a check list of the basic aspects that a manufacturer should have already started to implement if they wish to keep their device on the market and have a transition to the Regulation as smoother as possible.

Fill out the Check List

If your answer is NO to one or more questions, or if you are not sure, it could not be ready to the transition to the new Regulation and you could be at risk of not being able to market your devices in the EU when the time extention has elapsed. 

This is the right time to start to manage this switch and of not being unprepared (again) at the end of the transitory period.

At Di Renzo we are a team of specialised consultants in the sector of medical device

Our deep knowledge of the regulatory landscape in Europe allow us prompt identification of conformity gaps, the evaluation of project feasability and potential risks, through a regulatory strategy that is adjusted to your company needs.

Foto di aymane jdidi da Pixabay