Transcript the office for registration of medicinal products, medical devices and

THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS,
MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Borderline decisions –
Member States cooperation
Beata Koziożemska / Andrzej Karczewicz
Department of Medical Devices Surveillance,
Vigilance and Clinical Trials
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Still unresolved problems
Problems with correct demarcation between medical devices,
medicinal products, cosmetics and general use products is crucial
for the proper implementation of directives concerning medical
devices but these problems need still to be explained and
resolved.
According to Manual on Borderline: „Different interpretations of
Community legislation occur, and, can put public health at risk
and distort the internal market”. Therefore, it is very important in
the context of the free movement of medical devices to be
ensured and harmonized.
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Internal market
Internal market:
– harmonized decisions at the EU level
– the same chance for MFR, equal treatment of MFR
– uniform interpretation of definition - the same consideration
of given “borderline product”
Therefore, close cooperation between CAs is needed!
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Borderline difficulties
A difficulty with consideration, whether a given product falls under
the MDD, the AIMDD, the IVDD or other EU regulations arises due
to among others:
 the definition of medical device is very broad and ambiguous
- orthopedic shoe
- menthol patch
- germicidal lamps
- sunscreens with special indications
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Borderline difficulties (cont.)
 lack of unanimity
- 32 States
- more than 32 CAs
- 79 NBs (93/42/EEC)
 lack of borderline decisions
- vaginal ovules with Lactobacillus for gynecological use (2003)
- bleaching products for teeth (2002)
- glycerin suppositories (2005)
- head lice products (2006)
- simeticone/anti-flatulence (2008)
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Borderline difficulties (cont.)
 ambiguous borderline decisions
- microscopic slides, pipettes and mixers for IVD
- products for use in acute sore throat contain Icelandic Moss
 CAs do not follow to borderline decisions
- instruments for tattooing (MEDDEV 2.1/1)
- topic disinfectants (antiseptics) for use on patients
(MEDDEV 2.1/3 rev 3)
- plaster with capsaicin (Manual on Borderline)
- saliva alcohol screening test for motor vehicle drivers
(MEDDEV 2.14/1)
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Current system
Current procedure
– more than 200 CA Enquires, but only 41 in the Manual on
Borderline
– does not lead to legally binding solution
– borderline decisions are issued after a very long time
– sometimes borderline decisions are ambiguous
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Effective cooperation - what does it mean?
According to the Manual on Borderline:
Defining a given product as a medical device fall within the
competence of the CA where the product is on its market.
The Manual on Borderline does not relieve CA from its obligation
to render decisions in these areas for any individual product, on a
case-by-case basis. CA, acting under the supervision of the
courts, must proceed on a case-by-case basis, taking account of
all the product characteristics.
The Manual on Borderline does not prescribe which regulation
must be applied by CA to an individual product. It serves as one
out of many elements supporting the CA in its case-by-case
decision on individual products.
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Polish Act of 20 May 2010 on medical devices
If a product is mistakenly taken as a medical device, or if a
product is mistakenly not considered as a medical device and:
- the product is placed on the market or put into service in the
territory of Poland, or
- the product’s MFR, AP or importer responsible for placing the
product on the market has the place of residence or the
registered office on the territory of Poland, or
- a NB authorized by the Polish minister of health participated in
the conformity assessment of the product,
the Polish CA shall determine, by administrative decision, whether
the product is a medical device.
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Wrongly affixed CE marking
Where a CA establishes that the CE marking is missing in
violation of the Directive or where the CE marking has been
affixed in accordance with the procedures in this Directive, but
inappropriately, on products that are not covered by this Directive,
CA should apply Article “Wrongly affixed CE marking” of
Directive.
CA is not obliged to notify Commission and other CAs about
applying of this Article.
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
My questions
Is a Member State independent in its borderline decision?
In view of this, could we agree on different status of the same
product in other countries?
Is it possible to have one internal market with over 32 independent
decision makers?
Should CA notify the Commission and other CAs of their
borderline decisions?
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
My questions (cont.)
Should Manual Decision be mandatory for CAs to existing internal
market?
What is the acceptable timeframe to prepare the Manual Decision
necessary to enable realize CA’s tasks?
What happens if member states’ courts take contradictory
judgments on borderline or if courts’ judgment on borderline is
inconsistent with Manual Decision?
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THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS
Thank you for your attention
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