Ref. Ares(2019)1818790 - 19/03/2019
MDR / IVDR - IMPLEMENTATION ROLLING PLAN
This Rolling Plan contains the list of identified essential implementing acts and actions to be put in place by the Commission during the transitional period together with relevant information on expected timelines and state-of-play. The
information is organised into two main sections (implementing acts and other actions/initiatives). The document will be subject to quarterly review in order to provide the authorities and stakeholders with the most updated
information. This document shall be read in conjunction with the “MDR/IVDR roadmap”, produced by the Competent Authorities for Medical Devices project (CAMD) in cooperation with the Commission (and available at
https://www.camd-europe.eu/regulatory/medical-devices-regulation-vitro-diagnostics-regulation-mdr-ivdr-roadmap), which contains a much more comprehensive overview of all the initiatives (including guidance) expected to be
undertaken during the transitional period by the Commission and the National Competent Authorities
Latest update: February 2019
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
IMPLEMENTING REGULATIONS/ACTS
Implementing Act
Article 42(13) MDR
Definition of the list of codes and corresponding types of devices for the purpose of specifying
Adopted and published on 24
Notified bodies scope of
the scope of the designation of notified bodies.
26 November 2017 (Legal deadline)
1
November 2017
designation
COMPLETED
This action is an essential pre-condition for the launch of the designation procedure for Notified
Article 38(13) IVDR
Bodies
Implementing Act
November 2019
Common specifications laying down requirements related to reprocessing of single-use devices
concerning: — risk management, including the analysis of the construction and material, related
It shall be noted that, in the event that
Reprocessing of single-use
properties of the device (reverse engineering) and procedures to detect changes in the design of
those CS are not adopted by 26 May
Formal public consultation
2
Article 17(5) MDR
medical devices
the original device as well as of its planned application after reprocessing, — the validation of
2020, reprocessing shall be performed
(Q2 2019)
procedures for the entire process, including cleaning steps, — the product release and
in accordance with any relevant
performance testing, — the quality management system, — the reporting of incidents involving
harmonised standards and national
devices that have been reprocessed, and — the traceability of reprocessed devices.
provisions
Implementing Act
Common specifications for
Common specifications (CS) addressing for any of the groups of products listed in Annex XVI of
Informal consultation with
Articles 1(2) and 9(1)
3 products without a
the MDR, at least, application of risk management as set out in Annex I and, where necessary,
stakeholders on a draft text to be
MDR
Q1 2020
medical purpose
clinical evaluation regarding safety. Application of MDR to Annex XVI products depends on the
launched by Q1 2019
adoption of CS.
Implementing Act (no comitology involved)
Making provision for expert panels to be designated. Based on this implementing act, the
Q3 2019
Setting up of expert
recital 94
selection of experts will be carried out. Expert panels are tasked inter alia with the delivery of
4
Draft implementing act in preparation
panels
Article 106(1) MDR
opinions on the clinical evaluation of certain high-risk devices in the context of the pre-market
scrutiny.
Tasks of expert panels are described in Article 106(10).
1/6
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Survey with MDCG members and
stakeholders finalised. While the issue
Implementing Act (no comitology involved)
Setting up of expert
TBD
of expert laboratories is under
5
Article 106(7) MDR
Designation of expert laboratories. Tasks of expert laboratories are described in Article 106(7). It
laboratories
(not before 2020)
investigation, the appointment of
shall be noted that the designation of expert laboratories is not mandatory.
expert laboratories does not
constitute a priority
Setting up of new
Survey with MDCG members and
recital 94
Implementing Act (no comitology involved)
structures under IVDR:
stakeholders finalised. This is
6
Articles 48(6), 100(1)
Designation of EU reference laboratories, active in the IVD field. Tasks are described in Article
Q4 2019/Q1 2020
- EU reference
intended to support the drafting of
and (3) IVDR
100
laboratories
the future act.
Rules to facilitate
Survey with MDCG members and
fulfilment of tasks by EU
Implementing Act
stakeholders finalised. This is
7 reference laboratories and Article 100(8)(a)
Rules to facilitate application of IVDR Article 100 (2) listing the tasks of the EURLs; rules to ensure
Q4 2019/Q1 2020
intended to support the drafting of
to ensure their
compliance with criteria for an EURL listed in IVDR Article 100 (4)
the future act.
compliance with criteria
Implementing Act
Survey with MDCG members and
Article 106(13) MDR
Fees for expert panel
Definition of fees for the advice provided by expert panels
stakeholders finalised. This is
8
Q4 2019
services
intended to support the drafting of
the future act.
Survey with MDCG members and
Implementing Act
stakeholders finalised. This is
9 Fees for EURL services
Article 100(8)(b) IVDR
Q2 2020
Definition of fees for the advice/testing activities performed by EURL
intended to support the drafting of
the future act.
recital 94
Unique Device
Article 27(2) MDR
Q2 2019
Call for application for UDI issuing
Identification (UDI)
Implementing Act (no comitology involved)
10
entities expired on 25 January.
System: designation of
Designation of one or more entities to operate a system for assignment of UDIs (‘issuing entity’).
recital 94
Evaluation of applications ongoing.
issuing entities
Article 24(2) IVDR
2/6
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Implementing Act
Article 33(8) MDR
Definition of detailed arrangements necessary for the setting up and maintenance of Eudamed.
Drafting to start by Q1 2019
11 EUDAMED
Q4 2019
This IA is mainly related to support, change management and maintenance rules
Article 30(1) IVDR
As soon as the last Common Technical
Implementing Act/s
Specifications are adopted under the
Common specifications for Article 9 and 48(6)
Common Specifications for IVD Class D in the context of the scrutiny mechanism for high risk
current Directive 98/79/EC (adoption
12
Q4 2019
IVD Class D
IVDR
devices
expected Q1 2019), the new Common
Specifications under the Regulation
will be drafted
ACTIONS/INITIATIVES (OTHER THAN IMPLEMENTING REGULATIONS/ACTS)
42 applications received by the
Designation of Notified Bodies under the MDR and IVDR. Designation of Notified Bodies under
Commission services, 25 joint
Notified Bodies
As many Notified Bodies as possible
1
the Regulations is a pre-condition for carrying out of conformity assessments under the new
assessments carrried out and 3 more
designation
designated prior to May 2020
Regulations
already scheduled. Full scope of MDR
and IVDR covered in the applications.
COMPLETED
Legal deadline for first release: 26 May
First release done in due time (25
EUDAMED:
Plan for the implementation of the functional specifications for Eudamed to be drafted by the
2
Article 34(1) MDR
2018.
May). Work in progress for further
Implementation plan
Commission.
releases
3/6
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Version 3 of high-level functional
specifications were issued end of
October 2018. Version 4 finalised and
presented at the MDCG meeting of
February 2019. It is estimated that
EUDAMED: drawing up of
Functional specifications for Eudamed, to be drawn up by the Commission, in cooperation with
3
Article 34(1) MDR
Q1 2019
modules for clinical investigation and
functional specifications
the MDCG.
market surveillance might be only
partly or not at all available at the
time of application of the two
Regulations (due to workability
issues) but few months after.
First analysis of type of contract done.
Independent audit report based on which the Commission shall inform the MDCG when it has
Audit to start in Q3/Q4 2019.
EUDAMED: Audit of
Contract content to be determined
4
Article 34(2) MDR
verified that Eudamed has achieved full functionality and meets the drawn up functional
Must be finalised by Q1 2020.
functional specifications
starting from Q1 2019 (first draft of
specifications
technical annex ongoing)
Work in progress to elaborate
Eudamed may go-live from the moment a notice is published in the Official Journal of the
Notice to be published by 25 March
5 EUDAMED go-live
Article 34 MDR
functional specifications and
European Union after a positive independent audit was performed that satisfies the MDCG
2020
implement them
Detailed arrangements necessary for the setting up and maintenance of Eudamed means at least
EUDAMED: Setting of
6
MDR Art 33(8)
the setting of an helpdesk/application support for Eudamed (normal IT good practice and
Before Eudamed go-live (March 2020) Internal preparatory work has started.
helpdesk
implementing act obligation).
The new dedicated website and first
Updated information to be provided
updated library are live. New
In order to avoid bottle necks and to ensure access to medical devices, a communication
during the transitional period of the
factsheets have been published in
campaign targeting all stakeholders impacted by the Regulations is foreseen at least for 3 years.
Regulations.
7 Communication campaign
January 2019. Release of existing
Targeted factsheets are produced for each target and the webpages of DG GROW on medical
Examples of deliverables are
factsheets in some major non-EU
devices will be updated to provide more accurate and updated information.
information factsheets, targeted
languages has also started. Social
presentations, dedicated website.
media campaign under preparation.
Setting of MDCG as an expert group of the European Commission. MDCG, composed by MS
Expert advisory structure:
Established by the legal deadline
8
Article 103 MDR
experts and chaired by the Commission, provides advice on all matters related to the
26 November 2017 (Legal deadline)
Setting of MDCG
COMPLETED
implementation of the Regulation.
4/6
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Assessment of submitted applications
Expert advisory structure:
Setting of MDCG sub-groups, providing MDCG with the necessary expertise in relation to specific
from stakeholders associations
9 Setting of MDCG
Article 103 MDR
To be completed by Q1 2019
fields.
ongoing.
subgroups
Formal establishment of the MDCG
subgroups expected Q1 2019.
COMPLETED
Mandate to SCHEER on
Annex I Section 10.4.3
10
Mandate to the scientific Committee (SCHEER) to prepare guidelines on phthalates
26 May 2018 (Legal deadline)
in September 2017. SCHEER's opinion
phthalates
MDR
expected in mid-2019
On the basis of the report of the EU
task-force on nomenclature and the
indications provided by the MDCG at
EU medical device
Article 26 MDR and 23
11
Designation of the future EU medical device nomenclature to be used in the UDI database
Decision is expected by Q1 2019
its meeting of 30 November, the
nomenclature
IVDR
Commission is currently finalising its
assessment in the view of a final
decision to be taken by Q1 2019
5/6
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
The consultation of MS and
Cen/Cenelec on the scope of the
Article 10 of
mandate (number of standards) was
Regulation (EU) No
Request to the European Standardisation Organisations for development of standards in the field
completed. The consultation of MS
12 Standardisation mandate 1025/2012 (the
of medical devices - the existing standards harmonised under Medical Device Directives need to
Decision is expected by Q2 2019
and Cen/Cenelec on the draft
'Standardisation
be aligned to the new framework.
mandate (conditions for development
Regulation')
of standards) is to be launched by Q1
2019.
6/6