Declaration of Conformity for an Investigational product

Jen C

Involved In Discussions
#1
I am preparing an application to conduct a clinical study in Belgium (for the first time!). We have the application form, and thanks to a previous thread I found this website, which confirms the requirements.

I'm confused by the requirement for a declaration of conformity:
...declaration showing that the device meets the essential requirements except for those aspects covered by the clinical study, and showing that, concerning those aspects, every precaution has been taken to protect the health and safety of the patients
We do DoCs for our CE marked products, but I have never written one for an investigational product. This is an early feasibility study, so there are a lot of areas in which we do not conform.

Anyone done this before? Any recommended formats, etc.? Should I append our ER checklist to show where we conform and where we don't?

Any suggestions would be much appreciated!

Thanks,
Jen
 
Elsmar Forum Sponsor
#3
The words on your Belgian web-link are almost identical to those of the guidance document MEDDEV 2.7.2 (2008) titled "GUIDE FOR COMPETENT AUTHORITIES IN MAKING AN ASSESSMENT OF CLINICAL INVESTIGATION NOTIFICATION "

To quote:
A signed statement (by the managing director or regulatory affairs manager or manager responsible for compliance with the essential requirements)to the effect that the device in question complies with the essential requirements except with regard to those aspects of the device which are to be investigated; and that, in respect of those aspects, every precaution has been taken to protect the health and safety of the subject.
One would expect that Essential Requirements, such as Number 7 ((Chemical physical and biological properties) and Number 8 (Infection and microbial contamination) will have been well and truly sorted before getting anywhere near a patient.

In fact, it could be that the only ERs still to be answered or supported by your Clinical Investigation are the "General Requirements"

1.The devices must be designed and manufactured in such a way that,
when used under the conditions and for the purposes intended, they
will not compromise the clinical condition or the safety of patients, or
the safety and health of users or, where applicable, other persons,
provided that any risks which may be associated with their intended
use constitute acceptable risks when weighed against the benefits to the
patient and are compatible with a high level of protection of health and
safety.

3. The devices must achieve the performances intended by the
manufacturer and be designed, manufactured and packaged in such a way
that they are suitable for one or more of the functions referred to in
Article 1 (2) (a), as specified by the manufacturer.

6. Any undesirable side-effect must constitute an acceptable risk when
weighed against the performances intended.

So, perhaps, use your ER checklist to identify those requirements that are being tested as part of your Clinicals, then provide the signed document stating all others are dealt with.
 

Jen C

Involved In Discussions
#4
Thank you Pads38 - and my apologies for not seeing your response sooner! Not sure how I missed it.

So, continuing along this theme...what is the standard practice for creating an ER checklist for which we can't yet demonstrate full compliance? I am used to writing these for CE marked product, but if a product is still under investigation (in this case, going into first human use), we obviously can't claim compliance with all the requirements.

Should the ER checklist at this stage be aspirational - i.e., like a target of what standards we intend to comply with? (In which case, I assume this would be stated somewhere.) Or should we be stating only those standards etc. with which we are ALREADY in compliance?

Sorry, I am relatively new to EU and still wrapping my head around this whole ER checklist idea...

Thanks for any additional suggestions!
Jen
 
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