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Brussels, 18 October 2013

Subject: Support a safe, efficient and predictable regulatory system for medical devices in the upcoming Plenary vote

Dear Member of European Parliament,

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:

1. Approval system for medical devices

o ENVI amendments 136, 162, 163, 164, 166, 241, 329 (Compromise Amendment 22): Do not support
They introduce an extremely complex and bureaucratic new approval system including a case-by-case
centralised pre-market authorization without benefitting patient safety or SMEs.
o Plenary amendments 360, 361, 362, 363, 364, 365, 366, 367, 368, 369, 370, 371, 372, 373, 374, 378, 379:
Support
Eucomed remains convinced that a systematic scrutiny approach that targets the full system would be the best
approach and EMA’s involvement still remains questionable. However, the Plenary amendments go in the right
direction as they have clear merits over the ENVI compromise. We believe they provide a good basis for further
negotiations and improvements in discussions with the Council.
2. Single/multiple use of devices and safe reprocessing
o ENVI amendments 73, 74, 75, 113, 114, 115, 116, 117, 118, 245, 287, 289 (Compromise Amendment 3): Do
not support
They render all medical devices reusable by default, by increasing the risk for patients of being exposed to
contaminated products.
o Plenary amendments 349, 350, 351, 352, 357, 359, 375, 376, 377: Support
o Plenary amendment 358: Support provided that the sentence ‘with the exception of obligations linked to the
conformity assessment procedure’ is deleted.
All Plenary amendments go in the right direction as they eliminate the reusability of all devices by default and
set high standards for reprocessing. They might need further technical improvement in the Council negotiations.
3. Hazardous substances
o ENVI amendments 269, 270: Do not support
They apply a general ‘one-size-fits-all’ ban of hazardous substances without taking into account the medical
needs or the risk-benefit analysis of the device.
o Plenary amendment 355: Do not support
This amendment provides a heavy continuous requirement to provide data regardless of any change in safety
profile.
4. Clinical requirements
o ENVI amendments 176, 340 on Randomized Control Trials (RCTs): Do not support
RCTs should not be made mandatory as the only option for a study design. Where RCTs are not feasible or
meaningful, other scientifically valid study designs need to be allowed.
o ENVI amendments 175, 188, 335 on ‘clinical efficacy’: Call for a split vote
These amendments can only be accepted if the reference to ‘clinical efficacy’ is deleted, as this term is not the
appropriate reference for medical devices.
o Plenary amendment 356 on ‘clinical equivalence’: Support provided that via an oral amendment the word
‘equivalent’ is used instead of ‘identical’. This amendment will then acknowledge the scientifically justified use of
‘equivalency’ principle in clinical data.

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

Eucomed Aisbl info@eucomed.org www.eucomed.org VAT BE 0423.939.488

ANNEX - Further background information

1. Approval system for medical devices

- ENVI Compromise Amendment 22 introduces a heavier scrutiny procedure than originally proposed by the European
Commission, by adding an additional second layer of product assessment resulting in a centralized case-by-case pre-
marketing authorization for scrutinized products via a mandatory decision by the European Commission.
- Additionally, the European Medicines Agency (EMA), which currently specializes in overseeing pharmaceutical products
(not medical devices), will now be fully responsible for ‘Special Notified Bodies’.
- The process dilutes roles and responsibilities by putting up to 600 clinical experts organised in 21 subgroups, all having
EMA involvement, in charge of triggering and performing the scrutiny, where this should be the role of Member State
authorities (with the Commission) who are the ‘risk managers’.1
- This burdensome, bureaucratic approach will lead to a significant delay of the process and high costs for SMEs, ultimately
resulting in less availability of much-needed technologies for patients.
- Larger scope: the ENVI scrutiny covers high-risk devices (class III) and even medium-risk devices (class IIb) and applies
not only to new products, but also to any minor modification of those products. It erodes the principle of ‘clinical
equivalency’ that will delay the placing on the market of generic devices.
- These complex structures and lengthy, ambiguous process in the ENVI compromise neither serve patients nor
SMEs or innovation.

2. Single/ Multiple-use of devices and safe reprocessing

- This ‘one-size-fits-all’ amendment is not practical and does not take into consideration the vast range of more than half a
million medical devices, used both in the healthcare and homecare setting.
- The ENVI compromise will result in a complex and uncertain process with major delays anticipated, with many single-use
devices currently used by patient and doctors in Europe suddenly being considered reusable. Products could ultimately be
unsafe for patients.
- The costs and additional administrative burden for this proposed procedure are anticipated to be huge. Developing the
evidence that a device cannot be safely reprocessed will be a major challenge for manufacturers, and will be very costly
and burdensome. Manufacturers will need to carry out a series of tests and provide evidence on how many times and
under which conditions currently single-use and later multiple-use devices can be reprocessed. Aside from this, the cost
of a simple re-labeling of each and every one of the half a million devices as reusable by default, adds immense and
useless costs for manufacturers.
- This approach would deviate from the globally applied principle that products which are single-use are declared
as such and not vice versa. The proposal would also imply that products specified as ‘single-use’ in other jurisdictions
like the United States, Canada and Japan, would be re-labeled as ‘multiple-use’ in Europe.
- The ENVI compromise establishes a ‘negative list’ which contains devices that cannot be safely reprocessed. Managing
the procedure and the update of such a list will be a major challenge for the European Commission as it needs to be
product-specific and would imply the oversight of around 500,000 products.
- The original proposal by the European Commission takes a more reasonable approach and puts patient safety first:
before being reprocessed, the Commission calls for evidence that devices can be reprocessed safely and assigns the
appropriate level of responsibility to the reprocessor.

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.

3
Assessment Committee for Medical Devices (ACMD)