EN EN COMPROMISE AND CONSOLIDATED AMENDMENTS

146 Pages·2013·0.68 MB·English

EUROPEAN PARLIAMENT 2009 - 2014
Committee on the Environment, Public Health and Food Safety
2012/0266(COD)
23.9.2013
COMPROMISE AND CONSOLIDATED
AMENDMENTS
1 - 30
Draft report
Dagmar Roth-Behrendt
(PE507.972v02.00)
on the proposal for a regulation of the European Parliament and of the Council
on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No
178/2002 and Regulation (EC) No 1223/2009
Proposal for a regulation
(COM(2012)0542 –C7-0318/2012 –2012/0266(COD))
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United in diversity
AM_Com_LegCompr
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1. SCOPE
Amendment 1
EPP, S&D, ALDE, Greens, GUE, ECR,
Compromise amendment replacing Amendments 31, 271-281, IMCO27, IMCO28, IMCO29
(on Article) + 3, 152-155, IMCO1 (on Recital 8)
Proposal for a regulation
Article 3
Text proposed by the Commission
Amendment
1.The Commission may, at the request of a
1. The Commission mayon its own
Member State or on its own initiative, by
initiative or shall at the request of a
means of implementing acts, determine
Member State, by means of implementing
whether or not a specific product, or
acts on the basis of the opinions of the
category or group of products, falls within
MDCG and the MDAC referred to in
the definitions of 'medical device' or
Articles 78 and 78a respectively,
'accessory to a medical device'. Those
determine whether or not a specific
implementing acts shall be adopted in
product, or category or group of products,
accordance with the examination procedure
including borderline products, falls within
referred to in Article 88(3).
the definitions of 'medical device' or
'accessory to a medical device'. Those
implementing acts shall be adopted in
accordance with the examination procedure
referred to in Article 88(3).
2. The Commission shall ensure the
sharing of expertise between Member
States in the fields of medical devices, in
vitro diagnostic medical devices,
medicinal products, human tissues and
cells, cosmetics, biocides, food and, if
necessary, other products in order to
determine the appropriate regulatory
status of a product, or category or group
of products.
Or.en
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Recital 8
Text proposed by the Commission
Amendment
(8)It should be the responsibility of the
(8) In order to ensure consistent
Member States to decide on a case-by-case
classification across all Member States,
basis whether or not a product falls within
particularly with regards to borderline
the scope of this Regulation. If necessary,
cases, it should be the responsibility of the
the Commission may decide, on a case-by-
Commission, having consulted the MDCG
case basis, whether or not a product falls
and the MDAC, to decide on a case-by-
within the definition of a medical device
case basis whether or not a product or
or of an accessory to a medical device.
groups of products fall within the scope of
Since in some cases it is difficult to
this Regulation. Member States should
distinguish between medical devices and
also have the possibility to request the
cosmetic products, the possibility to take
Commission to take a decision on the
an EU-wide decision regarding the
appropriate regulatory status of a product,
regulatory status of a product should also
or category or group of products.
be introduced in Regulation No
1223/2009 of the European Parliament
and of the Council of 30 November 2009
on cosmetic products
Or.en
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2. ADVISORY BODY
Amendment 2
EPP, S&D, ALDE, Greens, GUE, ECR
Compromise amendment replacing Amendments 4, 190,211, 212 (Recital 7a) + 105, 702,
706-708,716,711,738 (Article 78a), 744-746, IMCO 11, 14, 129, 124, 128,126.
Proposal for a regulation
Article 78 a (new)
Text proposed by the Commission
Amendment
Medical Device Advisory Committee
1. The Commission shall establish a
multidisciplinary Medical Device Advisory
Committee (MDAC) composed of experts
and representatives of the relevant
stakeholders in order to provide support,
advice and expertise to the MDCG, the
Commission and Member States on
technical, scientific, social and economic
aspects of regulating medical devices and
in vitro diagnostic medical devices, such
as in the field of medical technology,
borderline cases involving medicinal
products, human tissues and cells,
cosmetics, biocides, food and, if
necessary, other products, as well as
further aspects of the implementation of
this Regulation.
2. When establishing the MDAC, the
Commission shall ensure a broad,
appropriate and balanced representation
of the disciplines relevant for medical
devices. The MDAC may establish under
its responsibility expert panels for specific
medical disciplines.
3. The MDAC shall be chaired by a
representative of the Commission. The
Commission shall provide the logistic
support to its operations.
4.The MDAC shall establish its rules of
procedure which shall enter into force
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after receiving a favourable opinion from
the Commission.
5. The MDAC shall ensure an appropriate
level of consultation of the EMA and the
EFSA when deliberating borderline cases
involving medicinal and food products.
6. The MDAC shall disclose the
declarations of interest of its members.
NB: This AM is horizontal, whenever reference in adopted AMs is made to advisory
committee, advisory group, advisory scientific board, it should be understood and replaced by
MDAC
Or.en
Recital 7 a (new)
Text proposed by the Commission
Amendment
(7a) A multidisciplinary Medical Device
Advisory Committee (MDAC) composed
of experts and representatives of the
relevant stakeholders should be set up to
provide scientific advice to the
Commission, the Medical Device
Coordination Group (MDCG) and
Member States on issues of medical
technology, regulatory status of devices
and other aspects of implementation of
this Regulation as necessary.
Or.en
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3. Single/multiple-use of devices and safe
reprocessing
S&D, ALDE, Greens, GUE
- These Compromise amendments are replacing Amendments 6, 7, 23-24, 32-36,
120-123, 125, 169-173, 249-251, 380, 382, 383-405, 436, 437, IMCO 6, IMCO
20-22, IMCO 42-50, IMCO60-61.
Part 1
Proposal for a regulation
Article 15 a (new)
Text proposed by the Commission Amendment
Article 15a
General principles on single-use devices
and reprocessing of reusable devices
1. All medical devices shall be treated as
reusable devices unless they areplaced on
thelist ofsingle-use devices referred to in
Article 15 b.
2. Devices labelled as "single-use" shall
not be reprocessed.
3. Any natural or legal person,including
health institutions as specified in Article
4(4), who wishes to reprocess a single-use
deviceto make it suitable for further use
within the Union,and who can provide
evidence that such a device could be
safely reprocessed shall be considered to
be the manufacturer of its reprocessed
deviceand be held liable for its
reprocessing activities. The natural or
legal person shall ensure the traceability
of the reprocessed device and shall
assume the obligations incumbent on
manufacturers laid down in this
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Regulation, with the exception of
obligations linked to the conformity
assessment procedure.
4. Only reusable devices that have been
placed on the Union market in
accordance with this Regulation, or prior
to [date of application of this Regulation]
in accordance with Directive 90/385/EEC
or Directive 93/42/EEC may be
reprocessed.
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Proposal for a regulation
Article 15 b (new)
Text proposed by the Commission Amendment
Article 15 b
List of single-usedevices unsuitable for
reprocessing
1. In accordance with Article 15 a (1) first
indent, the Commission, after the
mandatory consultation of the MDAC
shall establish,by means ofdelegated
acts, and regularly update, including by
adding or removing, a list of medical
devices or types of medical devices which
are unsuitable for reprocessing.
2.Thedecision to include or remove any
device or type of device from the list shall
be doneowing in particular to:
- their intended use in or on the
human body andthe body parts they
will be in contact with;
- the conditions of their use;
- their intended purpose;
- the material which they are
composed of;
- the severity of the disease that is
being treated;
- a genuine safety risk; and
- the latest scientific and
technological advancements in the
relevant fields and disciplines.
3. The delegated acts referred to in
paragraph 1 shall be adopted in
accordance with Article 89.
Or.en
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