procedure & dossier requirements
If a Notified Body wants to seek advice (Consultation Procedure)
from the MEB with regard to a substance that is an integral part of
a medical device but that is a medicinal product when used
separately, the MEB follows the procedure described below.
1. The MEB asks for written notification that advice (Consultation
Procedure) will be sought, preferably one to two months before
submission of the dossier. At this stage the Notified Body can, if
it wishes, also indicate that it would like to have a
pre-submission meeting. If prior Scientific Advice (or Regulatory
Advice) is being sought, then as with applications for medicinal
products this should normally have been requested at an earlier
stage. The MEB then proposes a timetable and assigns a consultation
number. This timetable indicates when the assessment can begin (and
where appropriate when the pre-submission meeting would take place)
and what the assessment period is (see also point 3). As the
capacity for assessment in the context of the consultation
procedure is not unlimited, the MEB might sometimes set a starting
date a few weeks or months after the announced dossier submission
date. If the Notified Body decides to waive consultation in view of
the proposed timetable or for other reasons, the MEB would like to
be informed of this as soon as possible. If the dossier is not
received until more than one or two weeks after the announced
submission date, then the timetable previously announced may have
to be revised.
2. The dossier is validated on receipt. This includes ascertaining
whether all the documents mentioned are actually present and
whether the dossier meets the requirements set out below (see
points 8 to 10). The MEB also decides whether the product can in
fact be regarded as a medical device containing as an integral
component a substance that is a medicinal product when used
separately and that merely supports the operation of the medical
The Notified Body will be informed as to whether the dossier is
valid within two weeks. Dossiers that are invalid will not be
processed. Notified Bodies will be given the opportunity to submit
additional documentation and information as rapidly as possible.
The dossier may then be declared valid. The timetable might be
revised as a result.
If the dossier is declared valid, an invoice for payment will be
sent to the Notified Body (for details of fees, see the document
Consultation procedure for medical devices: Fees). If the fee due
has not been received by 30 days after the invoice date, the
assessment will be stopped and will not resume until the amount
owed has been received. This might also mean that the deadlines
previously set out in the timetable are not met.
3. The assessment periods are:
Known substances (known applications)
New substances or new applications of known substances*
First assessment round
Second assessment round
* New substances are defined as substances that at
the time of the request for consultation were not included as
active ingredients in any medicinal product authorised in the
Known substances on the other hand are substances that at the time
of the request for consultation were included as active ingredients
in one or more medicinal products authorised in the Netherlands. If
the indication to which the consultation procedure relates is for a
therapeutic area different from the indications for which the
aforementioned medicinal products are authorised, then this is
regarded as a new application of a known substance.
** Variations are all changes relating to the quality, safety or
usefulness of the substance which is an integral component of the
medical device but which is a medicinal product when used
separately, and where a consultation with a competent authority has
already taken place with regard to this substance, which resulted
in the product’s certification. Some changes are so far-reaching
that the product has to be regarded as a new medical device (for
more information see: Fees).
4. Once the procedure has begun (once the dossier has been declared
valid), the Notified Body may at any time withdraw its request to
consult the MEB and ask a different competent authority for advice.
It is requested to notify the MEB of the name of the new competent
authority in this event. The MEB must be notified in writing
without delay of the withdrawal of consultation requests. Any fees
that have already been paid will not be reimbursed. Any outstanding
payments still have to be paid.
5. The advice requested will be provided in writing. It will
comprise one or more (sub) reports and a covering letter with a
recommendation arising from the attached (sub) report(s). The
recommendation may be:
- a positive opinion that the quality, safety and usefulness of
the substance has been sufficiently demonstrated in accordance with
the standards applied by law for the marketing authorisation of
- a request for more information;
- a negative opinion that the quality, safety and usefulness of
the substance has not been sufficiently demonstrated in accordance
with the standards applied by law for the marketing authorisation
of medicinal products.
If either a positive or negative opinion is issued, the
consultation is regarded as terminated.
If the MEB asks for more information, the Notified Body should
submit the data requested preferably within four months or within
another timescale set by the MEB. The Notified Body may ask for
this deadline to be extended. Such requests will always be answered
in writing, and a new date may be set if deemed appropriate. The
MEB normally reaches a final decision after two assessment rounds
at the most. An additional (third) assessment round may be needed
in exceptional cases in the light of new information brought to the
MEB’s attention (during a hearing, for example). The MEB decides
whether a third round is necessary.
If the additional information is not received within the agreed
time, the 'quality, safety and usefulness' of the substance is
regarded as insufficient and the consultation is considered
6. Once the consultation procedure has been completed, the Notified
Body is asked to inform the MEB of its decision on the medical
device in question, and to state whether its decision diverges from
the advice given by the MEB. If the Notified Body receives a
negative opinion from the MEB, it is asked to consult the Health
Care Inspectorate (Chief Inspector for Pharmacy and Medical
Technology) before granting a certificate.
7. The MEB does not consider itself to be under any obligation to
file the data submitted in the context of the consultation
procedure. Of course, data submitted will be treated
8. The following documentation is required, presented clearly and
with a table of contents:
- A fully completed and signed Consultation request form. N.B. when
requesting advice on a series of products, a separate form must
be completed for each presentation.
- A provisional opinion of the Notified Body on the suitability
of the medical device with the supporting medicinal substance.
If the Notified Body has not yet completed its assessment, it is
requested to submit a provisional opinion on the parts that have
already been assessed and a summary of the aspects that have yet to
be evaluated (e.g. biocompatibility investigation). N.B. this
provisional opinion should be stated on the Consultation request
- The documentation as described in "Commission Guidance Document: Medical Devices
(MEDDEV 2.1/3 Rev 3)" ( Dec 2009)
See under C.3
"Documentation to be provided by the Notified Body to the
The format (section headings and structure) of the MEDDEV document
can be used.
- the MEB would much prefer to receive the entire dossier on an
electronic data carrier (CD-Rom). However, the signed cover letter
from the Notified Body accompanying the dossier should be submitted
- The summary of the risk analysis - referred to in C.3. 1)
“General Information” of the MEDDEV document - should be attached
as an appendix to Module 5 rather than Module 1. If it is
impossible to submit all the data requested, arguments should be
presented for each section as to why this is not thought
- As far as the chemical-pharmaceutical and biological data are
concerned, the requirements for human medicinal products are set
out in considerable detail in Directives, Regulations, Decrees and
Guidelines. The data for Module 3 should comply with these
documents as far as possible.
N.B. In the case of substances of animal origin, attention must
be paid to viral safety and the risk of transfer of transmissible
spongiform encephalopathies (TSE) to humans.
- Where possible, all clinical data submitted by the manufacturer
of the medical device to the Notified Body should be provided.
Clinical data that is not directly relevant for supporting the
medicinal substance’s safety and usefulness can be included as an
appendix to Module 5.
- Only data relevant to the consultation should be
9. As already mentioned under point 8, the MEB would much
prefer to receive the entire dossier on an electronic data carrier
(CD-Rom). For electronic submissions, please refer to the MEB
website also. However, in case the dossier is submitted on paper,
submission of a single copy will be sufficient.
10. The Modules 3, 4 and 5 should preferably be written in Dutch or
English, but German and French are also acceptable.
The other documents should be written in Dutch or English. For more
information regarding the Consultation Procedure, please contact