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Subject: Support a safe, efficient and predictable regulatory system for medical devices in the upcoming Plenary vote
Ahead of the European Parliament Plenary vote on the revision of the Medical Devices Directives, Eucomed - the voice of Europe’s
medical device industry - appeal to you to vote for a system that increases patient safety and avoids unnecessary red tape and
bureaucracy.
In particular, we kindly ask you to consider our voting recommendation on the following key areas:
We encourage you to take our voting recommendation into account to achieve a safe, efficient and predictable regulatory system for
medical devices, for the benefit of both patients and industry.
Kind regards
Serge Bernasconi
Chief Executive Officer, Eucomed
3. Hazardous substances
- The ENVI amendments apply a general ‘one-size-fits-all’ phase-out/ban of hazardous substances without an evidence-
based justification and without taking into account the medical safety need of a device that in certain cases can only be
delivered through the use of certain hazardous substances.
- A risk-benefit analysis of the medical safety needs of the product, specific to the product category, should be carried out
before a phase-out of any hazardous substance. Any ban of substances should be patient-centric, not chemical-centric,
and should be based on an evidence-based medical opinion.
- For certain medical devices, hazardous substances can be substituted, e.g. DEHP-free urine bags. For other devices,
certain hazardous substances are critical to guarantee the ‘medical safety’ of the treatment (e.g. breathing tubes for
neonates need to be extremely flexible for this vulnerable age group; DEHP in blood bags guarantees longer blood
storage than without this substance).
4. Clinical requirements
- Randomized Control Trials (RCTs): RCTs cannot be the gold standard for all technologies and should not be made
mandatory. Where RCTs are not feasible or meaningful, other scientifically valid study designs need to be allowed.
- Efficacy: these amendments refer to ‘clinical efficacy’; however, ‘efficacy’ is not defined. Furthermore, while ‘efficacy’ is
the relevant requirement for pharmaceuticals, it is not suitable for medical devices. Therefore we call on all MEPs to
introduce an adequate definition of ‘performance’ along the lines of the World Health Organisation (WHO)’s definition of
‘effectiveness’ which is more appropriate for medical devices. This solution was proposed in IMCO with amendment 105.
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Assessment Committee for Medical Devices (ACMD)