BETA


2020/0060(COD) Medical devices

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI
Lead committee dossier:
Legal Basis:
RoP 163, TFEU 114-p1, TFEU 168-p4

Events

2020/05/20
   EP - End of procedure in Parliament
2020/05/13
   EC - Commission response to text adopted in plenary
Documents
2020/04/24
   Final act published in Official Journal
2020/04/23
   CSL - Draft final act
Documents
2020/04/23
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2020/04/23
   CSL - Final act signed
2020/04/17
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.

The European Parliament adopted its position at first reading under the ordinary legislative procedure by means of an urgent procedure.

Parliament supported the proposal to defer for one year (until 26 May 2021) the application of certain provisions of Regulation (EU) 2017/745 on medical devices in order to allow Member States, health establishments and economic operators to give priority to the fight against the coronavirus pandemic by continuing according to current procedures.

Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give necessary medical treatment to patients who are urgently in need of such treatment.

Given the unprecedented magnitude of the current challenges related to COVID-19, it is very likely that Member States, health institutions, economic operators and other relevant parties shall not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein.

By way of derogation from Directives 90/385/EEC and 93/42/EEC, it is specified that conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2021. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2021.

Documents
2020/04/16
   EP - Committee referral announced in Parliament, 1st reading
2020/04/14
   EP - Decision by committee, without report
2020/04/03
   EC - Legislative proposal published
Details

PURPOSE: to defer the application of certain provisions of Regulation (EU) 2017/745 on medical devices in order to allow Member States, health establishments and economic operators to give priority to the fight against the coronavirus pandemic.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure on an equal footing with the Council.

BACKGROUND: Regulation (EU) 2017/745 of the European Parliament and of the Council establishes a new regulatory framework to ensure the proper functioning of the internal market for medical devices. At the same time, it sets high standards of quality and safety for medical devices in order to meet common safety concerns as regards such devices. Regulation (EU) 2017/745 significantly reinforces key elements of the existing regulatory approach in Council Directive 90/385/EEC and Council Directive 93/42/EEC , such as the supervision of notified bodies, conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices, to improve health and safety.

The coronavirus pandemic and the resulting public health crisis represent an unprecedented challenge for Member States and a heavy burden for national authorities, health care institutions and economic operators.

The coronavirus crisis has created exceptional circumstances that require considerable additional resources and increased availability of vitally important medical devices such as medical gloves, surgical masks or intensive care equipment. None of these measures could reasonably have been anticipated at the time of the adoption of the Medical Devices Regulation.

These extraordinary circumstances have a significant impact on different areas covered by the Medical Devices Regulation. It is therefore very likely that Member States, health care institutions, economic operators and other stakeholders would not have been able to ensure its proper implementation and application from the date of application initially foreseen on 26 May 2020.

CONTENT: for exceptional reasons, in the current context of the coronavirus epidemic, the Commission proposes to defer by one year, to 26 May 2021, the date of application of the provisions of Regulation (EU) 2017/745 which should have applied from 26 May 2020.

The proposed amendment aims to achieve the objectives of Regulation (EU) 2017/745, namely the establishment of a rigorous, transparent, predictable and sustainable regulatory framework for medical devices that ensures a high level of protection of public health and patient safety and the proper functioning of the internal market for these devices.

At the same time, it is proposed to defer the date of repeal of Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices by one year. These postponements would ensure that an operational regulatory framework for medical devices would be in place from 26 May 2020.

In addition, the proposed amendment aims to ensure that, in exceptional cases, the Commission may adopt, as soon as possible, EU-wide derogations following national derogations, in order to effectively address potential shortages of vitally important medical devices in the EU.

In view of the urgent need to respond immediately to the public health crisis related to the COVID-19 pandemic, the proposed amending Regulation should enter into force as a matter of urgency.

Documents

Votes

Demande d'application de la procédure d'urgence: Dispositifs médicaux - C9-0098/2020 ( 2020/0060(COD) ) #

2020/04/16 Outcome: +: 680, -: 3, 0: 2
DE FR IT ES PL RO NL SE PT BE HU EL CZ AT BG SK DK IE FI LT HR LV SI CY MT LU EE
Total
91
78
75
58
50
30
29
21
21
20
20
21
19
18
16
14
14
13
13
11
12
8
8
6
6
6
7
icon: PPE PPE
183

Denmark PPE

For (1)

1

Finland PPE

2

Latvia PPE

2
2

Malta PPE

2

Luxembourg PPE

2

Estonia PPE

For (1)

1
icon: S&D S&D
143

Greece S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1

Estonia S&D

2
icon: Renew Renew
96

Italy Renew

For (1)

1

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Ireland Renew

2

Finland Renew

3

Lithuania Renew

2

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Luxembourg Renew

2

Estonia Renew

3
icon: ID ID
73

Netherlands ID

Against (1)

1

Belgium ID

2

Czechia ID

For (1)

1
3

Denmark ID

For (1)

1

Finland ID

2

Estonia ID

Abstain (1)

1
icon: Verts/ALE Verts/ALE
64

Spain Verts/ALE

2

Netherlands Verts/ALE

3

Sweden Verts/ALE

3

Portugal Verts/ALE

1

Belgium Verts/ALE

3

Czechia Verts/ALE

3

Austria Verts/ALE

2

Denmark Verts/ALE

2

Ireland Verts/ALE

2

Finland Verts/ALE

3

Lithuania Verts/ALE

2

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: ECR ECR
60

Germany ECR

For (1)

1

Greece ECR

1

Bulgaria ECR

2

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: GUE/NGL GUE/NGL
38

Netherlands GUE/NGL

For (1)

1

Sweden GUE/NGL

For (1)

1

Belgium GUE/NGL

For (1)

1

Czechia GUE/NGL

1

Denmark GUE/NGL

1

Finland GUE/NGL

For (1)

1

Cyprus GUE/NGL

2
icon: NI NI
28

Germany NI

2

Netherlands NI

1

Slovakia NI

2

Croatia NI

Against (1)

Abstain (1)

2

Vote final: Dispositifs médicaux - C9-0098/2020 ( 2020/0060(COD) ) #

2020/04/17 Outcome: +: 693, 0: 2, -: 1
DE FR IT ES PL RO NL BE SE CZ HU PT EL AT BG SK FI DK IE LT HR LV SI EE CY MT LU
Total
95
79
75
58
50
32
29
21
21
21
21
20
21
19
17
14
14
13
12
11
12
8
8
7
6
6
6
icon: PPE PPE
184

Denmark PPE

For (1)

1

Latvia PPE

2

Estonia PPE

For (1)

1
2

Malta PPE

2

Luxembourg PPE

2
icon: S&D S&D
144

Greece S&D

2

Denmark S&D

2

Lithuania S&D

2

Latvia S&D

2

Slovenia S&D

2

Estonia S&D

2

Cyprus S&D

2

Luxembourg S&D

For (1)

1
icon: Renew Renew
98

Italy Renew

For (1)

1

Hungary Renew

2

Austria Renew

For (1)

1

Slovakia Renew

2

Finland Renew

3

Ireland Renew

2

Lithuania Renew

2

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Estonia Renew

3

Luxembourg Renew

2
icon: ID ID
76

Netherlands ID

1

Czechia ID

2
3

Finland ID

2

Denmark ID

For (1)

1

Estonia ID

For (1)

1
icon: Verts/ALE Verts/ALE
66

Spain Verts/ALE

2

Netherlands Verts/ALE

3

Belgium Verts/ALE

3

Sweden Verts/ALE

3

Czechia Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

3

Finland Verts/ALE

3

Denmark Verts/ALE

2

Ireland Verts/ALE

1

Lithuania Verts/ALE

2

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: ECR ECR
61

Germany ECR

For (1)

1

Greece ECR

1

Bulgaria ECR

2

Lithuania ECR

1

Croatia ECR

For (1)

1

Latvia ECR

2
icon: GUE/NGL GUE/NGL
38

Netherlands GUE/NGL

For (1)

1

Belgium GUE/NGL

For (1)

1

Sweden GUE/NGL

For (1)

1

Czechia GUE/NGL

1

Portugal GUE/NGL

3

Finland GUE/NGL

For (1)

1

Denmark GUE/NGL

1

Cyprus GUE/NGL

2
icon: NI NI
29

Germany NI

2

Netherlands NI

1

Hungary NI

1

Slovakia NI

2

Croatia NI

Against (1)

2

History

(these mark the time of scraping, not the official date of the change)

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2020-04-03T00:00:00
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Legislative proposal
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  • title: OJ L 130 24.04.2020, p. 0018 url: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:130:TOC
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2020-05-20T00:00:00
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docs/0/docs/0/url
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docs/0
date
2020-04-17T00:00:00
docs
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type
Text adopted by Parliament, 1st reading/single reading
body
EP
events/3/summary
  • The European Parliament adopted a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.
  • The European Parliament adopted its position at first reading under the ordinary legislative procedure by means of an urgent procedure.
  • Parliament supported the proposal to defer for one year (until 26 May 2021) the application of certain provisions of Regulation (EU) 2017/745 on medical devices in order to allow Member States, health establishments and economic operators to give priority to the fight against the coronavirus pandemic by continuing according to current procedures.
  • Medical devices, such as medical gloves, surgical masks, equipment for intensive care and other medical equipment, play a crucial role in the context of the COVID-19 outbreak and the associated public health crisis to ensure the health and safety of Union citizens and to enable Member States to give necessary medical treatment to patients who are urgently in need of such treatment.
  • Given the unprecedented magnitude of the current challenges related to COVID-19, it is very likely that Member States, health institutions, economic operators and other relevant parties shall not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein.
  • By way of derogation from Directives 90/385/EEC and 93/42/EEC, it is specified that conformity assessment bodies which comply with this Regulation may be designated and notified prior to 26 May 2021. Notified bodies which are designated and notified in accordance with this Regulation may carry out the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation prior to 26 May 2021.
docs
  • date: 2020-04-17T00:00:00 docs: url: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.html title: T9-0053/2020 type: Text adopted by Parliament, 1st reading/single reading body: EP
  • date: 2020-04-23T00:00:00 docs: url: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:[%SECTOR]2020[%DESCRIPTOR]00010:EN:NOT title: 00010/2020/LEX type: Draft final act body: CSL
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date
2020-04-16T00:00:00
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Committee referral announced in Parliament, 1st reading/single reading
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EP
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2020-04-17T00:00:00
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Decision by Parliament, 1st reading/single reading
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EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0053_EN.html title: T9-0053/2020
events/4
date
2020-04-23T00:00:00
type
Final act signed
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CSL
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  • ENVI/9/02754
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New
Awaiting Council 1st reading position / budgetary conciliation convocation
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forecasts
  • date: 2020-04-17T00:00:00 title: Vote in plenary scheduled