When the technical documentation (TD) contains all mandatory documents and the QMS meets the requirements, the medical device can be offered for CE certification to the Notified Body.
Unfortunately, applying for a CE certification has a very long lead time. It starts with contacting a Notified Body that is allowed to certify the type of medical device and the class. The Notified Body does not have to be located in the Netherlands. In terms of lead time, it may be advisable to check outside the Netherlands whether there is a Notified Body that can indicate in advance what the lead times are.
Please note, a Notified Body must assess product safety and electromagnetic compatibility (EMC). However, this does not have to be the same Notified Body as the CE certification body. Also pay close attention to the marketing communications. It is not allowed to advertise or make claims for products that do not yet have market access. The Notified Body checks this.
Depending on the maturity of the organization and whether an existing QMS can be used, such as an ISO9001:2015 certified QMS which can be supplemented with a QMS suitable for developing a medical device and the availability of a quality department that can set up the necessary work processes, it will take an average organization about two years (1 FTE) to build the necessary QMS.
The speed that determines when a medical device can be brought to market depends on many factors. Overall, this will take three to six years of lead time. This also depends on the product class[1].
[1] For more information, see MedTech Europe Survey Report – MedTech Europe (page 8) and MDR Guide.pdf (fme.nl) (table 18, page 77)
