Ref. Ares(2019)5541658 - 03/09/2019
MDR / IVDR - IMPLEMENTATION ROLLING PLAN (internal)
This Rolling Plan contains the list of identified essential implementing acts, actions and guidance to be put in place by the Commission and/or the MDCG 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; 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: August 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
Adopted and published on 24
Notified bodies scope of
specifying 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
Article 38(13) IVDR
Notified 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
It shall be noted that, in the event that
material, related properties of the device (reverse engineering) and procedures to detect
Reprocessing of single-use
those CS are not adopted by 26 May
Implementing act undergoing formal
2
Article 17(5) MDR
changes in the design of the original device as well as of its planned application after
medical devices
2020, reprocessing shall be performed in
adoption procedure.
reprocessing, — the validation of procedures for the entire process, including cleaning
accordance with any relevant
steps, — the product release and performance testing, — the quality management system,
harmonised standards and national
— the reporting of incidents involving devices that have been reprocessed, and — the
provisions
traceability of reprocessed devices.
1/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Implementing Act
Discussion with Member States took
Common specifications for
Common specifications (CS) addressing for any of the groups of products listed in Annex XVI
Articles 1(2) and 9(1)
place in May and June 2019.
3 products without a medical
of the MDR, at least, application of risk management as set out in Annex I and, where
MDR
Q1 2020
Implementing act undergoing formal
purpose
necessary, clinical evaluation regarding safety. Application of MDR to Annex XVI products
adoption procedure.
depends on the adoption of CS.
Implementing Act (no comitology involved)
Making provision for expert panels to be designated. Based on this implementing act, the
Q3 2019
recital 94
selection of experts will be carried out. Expert panels are tasked inter alia with the delivery
Implementing act undergoing formal
4 Setting up of expert panels Article 106(1) MDR
of opinions on the clinical evaluation of certain high-risk devices in the context of the pre-
adoption procedure.
market scrutiny.
Tasks of expert panels are described in Article 106(10).
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
laboratories
(not before 2020)
investigation, the appointment of
106(7). It shall be noted that the designation of expert laboratories is not mandatory.
expert laboratories does not constitute
a priority
2/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Setting up of new
recital 94
Implementing Act (no comitology involved)
6 structures under IVDR:
Articles 48(6), 100(1)
Designation of EU reference laboratories, active in the IVD field. Tasks are described in
Q4 2019/Q1 2020
Call for nominations in preparation
- EU reference laboratories and (3) IVDR
Article 100
Rules to facilitate
fulfilment of tasks by EU
Implementing Act
Implementing act in preparation
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
Q4 2019/Q1 2020
to ensure their compliance
ensure compliance with criteria for an EURL listed in IVDR Article 100 (4)
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 intended
8
Q4 2019
services
to support the drafting of the future
act.
Implementing Act
Implementing act in preparation
9 Fees for EURL services
Article 100(8)(b) IVDR
Q2 2020
Definition of fees for the advice/testing activities performed by EURL
recital 94
Unique Device
Article 27(2) MDR
Implementing Act (no comitology involved)
May 2019
Implementing Act adopted on 6 June
Identification (UDI)
10
Designation of one or more entities to operate a system for assignment of UDIs (‘issuing
2019
System: designation of
recital 94
entity’).
COMPLETED
issuing entities
Article 24(2) IVDR
Implementing Act
Article 33(8) MDR
Definition of detailed arrangements necessary for the setting up and maintenance of
Implementing act in preparation
11 EUDAMED
Q4 2019
Eudamed. This IA is mainly related to support, change management and maintenance rules
Article 30(1) IVDR
3/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
As soon as the last Common Technical
Specifications are adopted under the
current Directive 98/79/EC (adoption
Implementing Act/s
expected beginning Q3 2019), the new
Common specifications for Article 9 and 48(6)
Common Specifications for IVD Class D in the context of the scrutiny mechanism for high
Common Specifications under the
12
Q4 2019
IVD Class D
IVDR
risk devices
Regulation will be drafted. Common
Technical Specifications under the
current Directive 98/79/EC on
combined tests were adopted in July
2019.
ACTIONS/INITIATIVES (OTHER THAN IMPLEMENTING REGULATIONS/ACTS)
52 applications received by the
Commission services, 33 joint
Designation of Notified Bodies under the MDR and IVDR. Designation of Notified Bodies
Notified Bodies
As many Notified Bodies as possible
assessments carrried out. Four Notified
1
under the Regulations is a pre-condition for carrying out of conformity assessments under
designation
designated prior to May 2020
Bodies already designated. Full scope
the new Regulations
of MDR and IVDR covered in the
applications.
Legal deadline for first release: 26 May First release done in due time (25 May
EUDAMED:
Plan for the implementation of the functional specifications for Eudamed to be drafted by
2
Article 34(1) MDR
2018.
2018). Work in progress for further
Implementation plan
the Commission.
releases to reflect adaptations.
4/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Version 4.1 (a new version 5 is to
come) of high-level functional
specifications were publically issued on
DG GROW website beginning of March.
EUDAMED: drawing up of
Functional specifications for Eudamed, to be drawn up by the Commission, in cooperation
Q1 2019 (high-level functional
3
Article 34(1) MDR
It is indicated that modules for clinical
functional specifications
with the MDCG.
specifications)
investigation and market surveillance
will not be available at the time of
application of the MDR due to
workability issues.
Independent audit report based on which the Commission shall inform the MDCG when it
Audit to start in Q3/Q4 2019.
Type of contract was determined.
EUDAMED: Audit of
4
Article 34(2) MDR
has verified that Eudamed has achieved full functionality and meets the drawn up
Must be finalised by Q1 2020.
Request for service contract was
functional specifications
functional specifications
launched
5/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
Work in progress to elaborate
functional specifications and
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
implement them
European Union after a positive independent audit was performed that satisfies the MDCG
2020
First release go-live just after notice is
published
Detailed arrangements necessary for the setting up and maintenance of Eudamed means at
EUDAMED: Setting of
6
MDR Art 33(8)
least the setting of an helpdesk/application support for Eudamed (normal IT good practice
Before Eudamed go-live (March 2020)
Internal preparatory work has started.
helpdesk
and implementing act obligation).
The new dedicated website and first
Updated information to be provided
updated library are live. A factsheet
In order to avoid bottle necks and to ensure access to medical devices, a communication
during the transitional period of the
addressed to healthcare professionals
campaign targeting all stakeholders impacted by the Regulations is foreseen at least for 3
Regulations.
7 Communication campaign
and health institutions has been
years. Targeted factsheets are produced for each target and the webpages of DG GROW on Examples of deliverables are information
published in June. Social media
medical devices will be updated to provide more accurate and updated information.
factsheets, targeted presentations,
campaign and targeted press release
dedicated website.
currently ongoing
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.
Expert advisory structure:
Subgroups operational as from 1st
Setting of MDCG sub-groups, providing MDCG with the necessary expertise in relation to
9 Setting of MDCG
Article 103 MDR
To be completed by Q1 2019
March 2019
specific fields.
subgroups
COMPLETED
6/7
Expected timelines
No.
Subject
Legal basis
Description
(expected date of final adoption/date
State-of-play/Next step
of accomplishment)
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 Q3 2019.
EU medical device
Article 26 MDR and 23
Decision published on the DG GROW
11
Designation of the future EU medical device nomenclature to be used in the UDI database
Decision is expected by Q1 2019
nomenclature
IVDR
website in March 2019 COMPLETED
Article 10 of Regulation Request to the European Standardisation Organisations for development of standards in
(EU) No 1025/2012
Draft mandate undergoing adoption
12 Standardisation mandate
the field of medical devices - the existing standards harmonised under Medical Device
Decision is expected by Q3 2019
(the 'Standardisation
procedure.
Directives need to be aligned to the new framework.
Regulation')
7/7