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Insight Report Vol. 5 No.3
Complying with the IVD Directive – Areas needing a better
understanding (not so different than other compliance issues)!
It has come to my attention that there is a general lack of basic
knowledge concerning compliance with the IVD Directive for putting the CE
mark on your IVD products for the European Community. With that thought in
mind, I have put together some information that it should be of interest
to all our readers about the many pitfalls involved in compliance issues.
Not being able to fully comply with the IVDD is comparable to not being
able to obtain a 510(k): a situation that can cause a serious problem in
being able to legally market your product the EU. Many of the problems
that companies are having in complying with the IVDD have already been
felt by the medical device industry when trying to comply with the MDD
several years back.
A. UNDERSTANDING THE REGULATORY REQUIREMENTS.
Interesting enough, the IVDD is just like any other regulation --
everything is not just black and white. In many cases, having a clear
understanding of the regulatory terminology, knowing current policy (which
is how the requirements are interpreted), as well as being familiar as to
how the requirements apply to your products can mean the difference
between successfully achieving full compliance and legally placing the CE
Mark on your product or heading down a blind alley and causing regulatory
problems.
B. AVOID MISCONCEPTIONS!
(Don’t think that the IVD Directive Essential Requirements are easy to
follow)
Each IVD product has to be individually reviewed to determine which of the
IVDD requirements are necessary to comply with. The Essential Requirements
are detailed in Annex I of the IVDD, European Parliament Directive
98/79/EC. Please be aware that the Essential Requirements could vary from
product to product. For example:
a: Does your device use electricity? If so, then your product must
meet all the electrical requirements? Do you also require EMC testing?
b: Safety-testing is a requirement that is cannot be overlooked.
c: For the CE mark, some products require that you have a quality
system in place. You have to determine if your product falls into this
category. If so, meeting the ISO standard could be cause major delays in
getting your CE mark.
Not fully understanding these requirements could cause problems in
getting your CE mark on schedule.
C. RECOGNIZE THE NEED FOR A MULTILINGUAL DOCUMENTATION STRATEGY!
What languages are required on your labeling is one area that causes the
most problems in understanding the Directive,. As with the MDD, the CE
Marking process for IVDs requires that product packaging, labeling and
instructions for use meet the Essential Requirements and national
transpositions. It is essential to develop a multilingual documentation
strategy within the context of your conformity assessment process. Only
then can you determine what documentation needs to be translated and how
long it will take to do. Translation is a critical component of the CE
Marking process. There are many services that will provide language
translations in accordance with the Directive requirements.
D. THE TECHNICAL FILE (TF) PREPARATION IS PARAMOUNT IN
SUPPORTING YOUR CE MARK.
( An incomplete (TF) can cause serious problems in the future )
The preparation of your TF, understanding how to create your technical
documentation to address the Essential Requirements and comply with the
appropriate Common Technical Specifications could require a great deal of
time, especially if you are inexperienced in this process.
If your IVD is Type I and you are self-certifying your products, you
may need to develop a less-involved technical file; however, understanding
that your technical file is subject to possible audits by the Competent
Authorities of the countries where your product is imported into, is
important. If you have high-risk products, you will be required to deliver
a detailed design dossier for review by your selected Notified Body. An
incomplete TF can cause delays in getting your CE mark and would result in
refused entry.
E. APPLYING THE CE MARK WITHOUT A COMPREHENSIVE RISK ANALYSIS IS
A MAJOR AREA THAT IS OFTEN OVERLOOKED.
Regardless of the product, you must perform a Risk Analysis, this is
required of Type I self-certifying products as well as the Type II IVDs.
For example you have to seek an answer to this type of questions (this is
equivalent to a faultree analysis in the FDA’s Design Control
requirements):
a: What can go wrong with your IVD?
b: What precautions have you taken to insure the safe use of your
product?
c: What have you done to sufficiently communicate product- related
risks to users while insuring that you're in compliance with the Essential
Requirements? (this information should be in your Design History File or
part of your 510(k) submission.)
F. ATTEMPTING TO GET A CE MARK WITHOUT CONDUCTING A
PERFORMANCE EVALUATION. (Design Review Validation)
If you develop products that are either high risk (Annex II) or
innovative, you may need to carry out a performance evaluation. This
evaluation must be carefully planned, monitored and statistically valid to
be accepted as justification for CE Marking. If you are manufacturing your
IVD for the US market, this would be equivalent to your Design Validation.
G. GOING GLOBAL WITHOUT A MULTILINGUAL LABELING STRATEGY.
Unfortunately, in marketing a medical device or an IVD in Europe, a
company must determine which languages to apply to the labeling. With the
multiply languages the next creative step is to accommodate the additional
text that will result from translation. It is hard to believe but it is
possible that for every word placed on a package insert or label, there
could be 20 additional words if all of the official EU languages are
included. Companies must determine whether packages need to be redesigned
to fit the translations. Working with a specialist or your Authorized
Representative could provide you expert guidance in this area.
H. THE SELECTION OF JUST ANY AUTHORIZED REPRESENTATIVE TO
REPRESENT YOUR PRODUCTS COULD BE A MISTAKE.
The selection of an Authorized Representative is as an important decision
for an IVD as it was for the medical device manufacturer. Authorized
Representatives assume joint product responsibility in partnership with
you, in the EU, for the correct use of the CE Mark. An experienced firm
knows the regulations and requirements and will keep their client
manufacturers up-to-date on regulatory changes. Price should not be the
selection criteria. History, reliability, and professionalism should weigh
heavy in your choice of an AR.
The medical device industry did it though there were some bumps and
bruises along the way. The IVD industry can take some lessons from the
medical device industry to prevent a repeat of the same problems.
For more information on the IVDD or assistance in preparing your
Technical File, achieving ISO certification please contact mdi’s office at
info@mdiconsultants.com .
The next Insight Report – An FDA Experience
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