BETA


2021/0323(COD) Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices

Progress: Procedure completed

RoleCommitteeRapporteurShadows
Lead ENVI
Committee Opinion IMCO
Committee Opinion EMPL
Lead committee dossier:
Legal Basis:
RoP 163, TFEU 114, TFEU 168-p4

Events

2022/01/28
   Final act published in Official Journal
2022/01/25
   CSL - Draft final act
Documents
2022/01/25
   CSL - Final act signed
2021/12/20
   EP/CSL - Act adopted by Council after Parliament's 1st reading
2021/12/15
   EP - Decision by Parliament, 1st reading
Details

The European Parliament adopted by 687 votes to 6, with 4 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.

The European Parliament adopted its position at first reading under the ordinary legislative procedure by taking over the Commission's proposal.

The objectives of this amending Regulation are to extend the transitional periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices, to introduce additional transitional provisions in that Regulation and to defer the application of the provisions of that Regulation with regard to devices manufactured and used internally.

In vitro diagnostic medical devices are essential for the health and safety of EU citizens and SARS-CoV-2 tests are particularly important for the fight against the COVID-19 pandemic. Given the unprecedented scale of the current challenges, it is very likely that Member States, healthcare

institutions, notified bodies, economic operators and other stakeholders will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022.

In order to ensure legal certainty and to avoid any disruption in the supply of these essential health products, this Regulation extends the existing transitional period for devices covered by certificates issued under Directive 98/79/EC and introduces tailor-made transitional periods for devices that are to be subject to conformity assessment involving notified bodies for the first time in accordance with Regulation (EU) 2017/746.

The length of the transitional period should depend on the risk class of the device concerned:

- for high-risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transitional period ends on 26 May 2025 and 26 May 2026 respectively, and

- for low-risk devices such as Class B devices and Class A sterile marketed devices, 26 May 2027.

The amending regulation also introduces a transitional period for the requirements applicable to devices manufactured and used within the same health institutions (in-house devices).

Documents
2021/12/13
   EP - Debate in Parliament
2021/12/08
   ESC - Economic and Social Committee: opinion, report
Documents
2021/11/21
   ES_PARLIAMENT - Contribution
Documents
2021/10/27
   EP - Decision by committee, without report
2021/10/18
   EP - Committee referral announced in Parliament, 1st reading
2021/10/14
   EC - Legislative proposal published
Details

PURPOSE: to propose a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 to prevent disruption in the supply of these essential healthcare products.

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

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

BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022 and introduce substantial changes in the sector.

One of the main changes concerns the involvement of independent conformity assessment bodies (‘notified bodies’). Currently, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) is subject to notified body control under Directive 98/79/EC. Under the Regulation, around 80% of in vitro diagnostic medical devices will be under the control of notified bodies, the vast majority of them for the first time.

The COVID-19 public health crisis has created extraordinary circumstances that demand substantial additional resources, as well as increased availability of vitally important in vitro diagnostic medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/746. Data on market readiness collected by the European Commission show that Member States, health institutions, notified bodies and economic operators will not be in a position to comply with the new rules within the timeframe foreseen .

In vitro diagnostic medical devices are essential for the health and safety of Union citizens and SARS-CoV-2 tests, in particular, are vital for the fight against the pandemic. Therefore, it is necessary to revise the transitional arrangements to allow for a gradual implementation of the Regulation in order to ensure an uninterrupted supply of these devices on the Union market.

The European Parliament , in a cross-party letter of 11 May 2021 signed by several political groups, called on the Commission to present a legislative proposal to smooth the transition to the new regulatory framework and to ensure the availability of in vitro diagnostic medical devices on the EU market.

CONTENT: in order to ensure legal certainty and to avoid potential market disruption, the Commission proposes to extend the existing transitional period for devices covered by a certificate issued under Directive 98/79/EC and to introduce tailored transitional periods for devices that are to be subject to conformity assessment involving notified bodies for the first time under Regulation (EU) 2017/746.

The length of the transitional period should depend on the risk class of the device concerned :

- for high-risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transitional period ends on 26 May 2025 and 26 May 2026, and

- for low-risk devices such as Class B and A sterile devices, 26 May 2027.

The Commission proposes to also introduce a transitional period for the requirements for devices manufactured and used within the same health institution (‘in-house devices’). This will give health institutions extra time to comply with the new requirements and ensure that in-house tests, which are often essential –especially for rare diseases, can continue to be developed in clinical laboratories.

Documents

Votes

Dispositions transitoires relatives à certains dispositifs médicaux de diagnostic in vitro et l’application différée des exigences en matière de dispositifs internes - Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices - Übergangsbestimmungen für bestimmte In-vitro-Diagnostika und späterer Geltungsbeginn der Anforderungen an hausinterne Produkte - COM(2021)0627 - C9-0381/2021 - 2021/0323(COD) - Demande d'application de la procédure d'urgence #

2021/12/13 Outcome: +: 680, -: 7, 0: 2
DE FR IT ES PL RO NL BE CZ HU SE PT AT BG SK DK EL FI IE LT HR LV SI EE MT CY LU
Total
91
78
75
58
51
32
29
21
21
21
20
20
18
17
14
14
19
13
13
11
12
8
8
7
6
6
6
icon: PPE PPE
173

Hungary PPE

1

Denmark PPE

For (1)

1

Latvia PPE

2

Estonia PPE

For (1)

1

Malta PPE

2
2

Luxembourg PPE

2
icon: S&D S&D
139

Czechia S&D

For (1)

1

Greece S&D

For (1)

1

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
99

Italy Renew

3

Poland Renew

1

Hungary Renew

2
3

Austria Renew

For (1)

1

Finland Renew

3

Ireland Renew

2

Lithuania Renew

1

Croatia Renew

For (1)

1

Latvia Renew

For (1)

1

Slovenia Renew

2

Estonia Renew

3

Luxembourg Renew

2
icon: Verts/ALE Verts/ALE
71

Spain Verts/ALE

3

Poland Verts/ALE

For (1)

1

Netherlands Verts/ALE

3

Belgium Verts/ALE

3

Czechia Verts/ALE

3

Sweden Verts/ALE

3

Portugal Verts/ALE

1

Austria Verts/ALE

2

Denmark Verts/ALE

2

Finland Verts/ALE

2

Ireland Verts/ALE

2

Lithuania Verts/ALE

For (1)

Abstain (1)

2

Latvia Verts/ALE

1

Luxembourg Verts/ALE

For (1)

1
icon: ID ID
70

Netherlands ID

Against (1)

1

Czechia ID

2
3

Denmark ID

For (1)

1

Finland ID

2

Estonia ID

For (1)

1
icon: ECR ECR
64

Germany ECR

1

Romania ECR

Against (1)

1

Bulgaria ECR

2

Slovakia ECR

For (1)

1

Greece ECR

1

Lithuania ECR

1

Croatia ECR

1

Latvia ECR

2
icon: The Left The Left
38

Netherlands The Left

For (1)

1

Belgium The Left

For (1)

1

Czechia The Left

1

Sweden The Left

For (1)

1

Denmark The Left

1

Finland The Left

For (1)

1

Cyprus The Left

2
icon: NI NI
35

Germany NI

2

Slovakia NI

2

Lithuania NI

1

Croatia NI

Against (1)

Abstain (1)

2

History

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

docs/0
date
2021-12-08T00:00:00
docs
title: CES5475/2021
type
Economic and Social Committee: opinion, report
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docs/0
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Legislative proposal
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https://dmsearch.eesc.europa.eu/search/public?k=(documenttype:AC)(documentnumber:5475)(documentyear:2021)(documentlanguage:EN)
docs/1
date
2021-12-08T00:00:00
docs
title: CES5475/2021
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Economic and Social Committee: opinion, report
body
ESC
docs/2
date
2021-11-21T00:00:00
docs
url: https://connectfolx.europarl.europa.eu/connefof/app/exp/COM(2021)0627 title: COM(2021)0627
type
Contribution
body
ES_PARLIAMENT
docs/3
date
2021-11-22T00:00:00
docs
url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2021)0627 title: COM(2021)0627
type
Contribution
body
ES_PARLIAMENT
events/0
date
2021-10-14T00:00:00
type
Legislative proposal published
body
EC
docs
summary
procedure/Legislative priorities
  • title: The EU’s response to the Covid-19 pandemic url: https://oeil.secure.europarl.europa.eu/oeil/popups/thematicnote.do?id=2065000&l=en
events/6
date
2022-01-28T00:00:00
type
Final act published in Official Journal
docs
procedure/final
title
Regulation 2022/112
url
https://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32022R0112
procedure/stage_reached
Old
Procedure completed, awaiting publication in Official Journal
New
Procedure completed
docs/1
date
2021-12-08T00:00:00
docs
title: CES5475/2021
type
Economic and Social Committee: opinion, report
body
ESC
events/4
date
2021-12-20T00:00:00
type
Act adopted by Council after Parliament's 1st reading
body
EP/CSL
procedure/stage_reached
Old
Awaiting Council's 1st reading position
New
Procedure completed, awaiting publication in Official Journal
events/4
date
2022-01-25T00:00:00
type
Final act signed
body
CSL
docs/1/date
Old
2022-01-19T00:00:00
New
2022-01-25T00:00:00
docs/1
date
2022-01-19T00:00:00
docs
title: 00079/2021/LEX
type
Draft final act
body
CSL
docs/1
date
2021-12-15T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html title: T9-0498/2021
type
Text adopted by Parliament, 1st reading/single reading
body
EP
events/3/summary
  • The European Parliament adopted by 687 votes to 6, with 4 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices.
  • The European Parliament adopted its position at first reading under the ordinary legislative procedure by taking over the Commission's proposal.
  • The objectives of this amending Regulation are to extend the transitional periods provided for in Regulation (EU) 2017/746 on in vitro diagnostic medical devices, to introduce additional transitional provisions in that Regulation and to defer the application of the provisions of that Regulation with regard to devices manufactured and used internally.
  • In vitro diagnostic medical devices are essential for the health and safety of EU citizens and SARS-CoV-2 tests are particularly important for the fight against the COVID-19 pandemic. Given the unprecedented scale of the current challenges, it is very likely that Member States, healthcare
  • institutions, notified bodies, economic operators and other stakeholders will not be in a position to ensure the proper implementation and full application of that Regulation from 26 May 2022.
  • In order to ensure legal certainty and to avoid any disruption in the supply of these essential health products, this Regulation extends the existing transitional period for devices covered by certificates issued under Directive 98/79/EC and introduces tailor-made transitional periods for devices that are to be subject to conformity assessment involving notified bodies for the first time in accordance with Regulation (EU) 2017/746.
  • The length of the transitional period should depend on the risk class of the device concerned:
  • - for high-risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transitional period ends on 26 May 2025 and 26 May 2026 respectively, and
  • - for low-risk devices such as Class B devices and Class A sterile marketed devices, 26 May 2027.
  • The amending regulation also introduces a transitional period for the requirements applicable to devices manufactured and used within the same health institutions (in-house devices).
docs/1
date
2021-12-15T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html title: T9-0498/2021
type
Text adopted by Parliament, 1st reading/single reading
body
EP
events/2
date
2021-12-13T00:00:00
type
Debate in Parliament
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/CRE-9-2021-12-13-TOC_EN.html title: Debate in Parliament
events/3
date
2021-12-15T00:00:00
type
Decision by Parliament, 1st reading
body
EP
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2021-0498_EN.html title: T9-0498/2021
procedure/stage_reached
Old
Awaiting Parliament's position in 1st reading
New
Awaiting Council's 1st reading position
events/1
date
2021-10-27T00:00:00
type
Decision by committee, without report
body
EP
forecasts
  • date: 2021-12-13T00:00:00 title: Debate in plenary scheduled
  • date: 2021-12-13T00:00:00 title: Vote in plenary scheduled
procedure/legal_basis/0
Rules of Procedure EP 163
procedure/stage_reached
Old
Awaiting committee decision
New
Awaiting Parliament's position in 1st reading
forecasts/0/title
Old
Indicative plenary sitting date
New
Debate in plenary scheduled
forecasts/1
date
2021-12-13T00:00:00
title
Vote in plenary scheduled
docs/1
date
2021-11-22T00:00:00
docs
url: http://www.connefof.europarl.europa.eu/connefof/app/exp/COM(2021)0627 title: COM(2021)0627
type
Contribution
body
ES_PARLIAMENT
forecasts
  • date: 2021-12-13T00:00:00 title: Indicative plenary sitting date
commission
  • body: EC dg: Health and Food Safety commissioner: KYRIAKIDES Stella
committees/1/opinion
False
docs/0/summary
  • PURPOSE: to propose a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 to prevent disruption in the supply of these essential healthcare products.
  • PROPOSED ACT: Regulation of the European Parliament and the Council.
  • ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
  • BACKGROUND: Regulation (EU) 2017/746 on in vitro diagnostic medical devices establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. The new Regulation will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022 and introduce substantial changes in the sector.
  • One of the main changes concerns the involvement of independent conformity assessment bodies (‘notified bodies’). Currently, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) is subject to notified body control under Directive 98/79/EC. Under the Regulation, around 80% of in vitro diagnostic medical devices will be under the control of notified bodies, the vast majority of them for the first time.
  • The COVID-19 public health crisis has created extraordinary circumstances that demand substantial additional resources, as well as increased availability of vitally important in vitro diagnostic medical devices, that could not reasonably have been anticipated at the time of adoption of Regulation (EU) 2017/746. Data on market readiness collected by the European Commission show that Member States, health institutions, notified bodies and economic operators will not be in a position to comply with the new rules within the timeframe foreseen .
  • In vitro diagnostic medical devices are essential for the health and safety of Union citizens and SARS-CoV-2 tests, in particular, are vital for the fight against the pandemic. Therefore, it is necessary to revise the transitional arrangements to allow for a gradual implementation of the Regulation in order to ensure an uninterrupted supply of these devices on the Union market.
  • The European Parliament , in a cross-party letter of 11 May 2021 signed by several political groups, called on the Commission to present a legislative proposal to smooth the transition to the new regulatory framework and to ensure the availability of in vitro diagnostic medical devices on the EU market.
  • CONTENT: in order to ensure legal certainty and to avoid potential market disruption, the Commission proposes to extend the existing transitional period for devices covered by a certificate issued under Directive 98/79/EC and to introduce tailored transitional periods for devices that are to be subject to conformity assessment involving notified bodies for the first time under Regulation (EU) 2017/746.
  • The length of the transitional period should depend on the risk class of the device concerned :
  • - for high-risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transitional period ends on 26 May 2025 and 26 May 2026, and
  • - for low-risk devices such as Class B and A sterile devices, 26 May 2027.
  • The Commission proposes to also introduce a transitional period for the requirements for devices manufactured and used within the same health institution (‘in-house devices’). This will give health institutions extra time to comply with the new requirements and ensure that in-house tests, which are often essential –especially for rare diseases, can continue to be developed in clinical laboratories.
events
  • date: 2021-10-18T00:00:00 type: Committee referral announced in Parliament, 1st reading body: EP
procedure/dossier_of_the_committee
  • ENVI/9/07442
procedure/stage_reached
Old
Preparatory phase in Parliament
New
Awaiting committee decision