State of play of Joint implementation Plan on actions considered necessary to ensure the sound functioning

of the new framework for medical devices under the MDR (02/07/2020)

N° Priority actions Legal Justification for updating of tasks Deadline

by May 2020 basis and/or deadline
1 EUDAMED
- Make available the actor Actors registration module deployment Postponed to Q4
registration module. and use postponed, but development 2020 for actors
continues as planned. registration module,
including SRN.
Possibility to make it available
separately or the first 3 modules By Q2 2021 for the
together: 1) actors registration, 2) devices and
devices registration including UDI, 3) certificates modules
certificates.

- Provide regular updates on the To share EUDAMED development On a regular basis in

development of EUDAMED. Art 123 plan and provide visibility on next the MDCG Subgroup
3) d) steps. on EUDAMED

- EUDAMED guidance

1. Guidance on administrative and

technical solutions in the absence 1. Document still required since
Eudamed planned to be fully 1. Endorsement
of EUDAMED.
available by May 2022 and new by Q3 2020
DoA by May 2021.

2. Position paper on the use of the 2. Endorsement by

actor registration module in 2. Document still required in line
Q3 2020
Member States. with the decision of the MDCG
on 11. March 2020.
- Establishing an MDCG subgroup Facilitate coordination and Established in Q2
on EUDAMED. interaction policy and IT. 2020 (first meeting
on 25/6/2020)

Selection of
observers to be
finalised in Q3
2 Clinical evaluation
2 guidance documents

1. on equivalence. Art 61 1. To provide guidance on the

and demonstration of equivalence, 1. Published in
Annex based on data pertaining to an April 2020
XIV already existing device on the
market, for the purpose of CE-
marking under the MDR.

2. on clinical evidence needed for 2. To provide guidance for 2. Published in

legacy medical devices. manufacturers and notified April 2020
bodies to prepare for conformity
assessment according to the
MDR of medical devices
currently certified under the
directives.
3 Transitional provisions
3 guidance documents

1. on interpretation / Art 1. Endorsed on

implementation of “significant 120 (2) 12/03/2020
changes” in accordance with Art and 3)
120(3) of the MDR.

2. on transitional provisions for 2. Endorsed on

consultations of authorities on 10/06/2020
devices containing ancillary
medicinal products and on devices
manufactured using TSE
susceptible animal tissues.
 3. on how affected manufacturers of Art
some class I devices can make 120(3) 3. Endorsed on
efficient use of the transitional and (4) 12/3/2020;
provisions. requires minor
updating to reflect
new DoA

4 Monitoring of devices availability

and measures to prevent or remedy
shortages
1. 1 year extension of deadline for Request for bi-weekly
1. Request regular reporting by renewal of MDD certificates reporting from notified
industry and notified bodies and but several months of NB bodies as soon as the
monitor market developments and activities potentially lost in covid-19 situation
activities performed by notified 2020 due to Covid 19 crisis. allows
bodies aiming at detecting
possible delays that could bring to To monitor specifically
shortage of devices on the market. certificates which will expire in
2020 and 2021

2. Examine different means for 2. Specific actions related to

taking measures to ensure COVID-19:
availability of safe and critical
medical devices and provide - COM Recommendation on Published on
guidance, as appropriate. conformity assessment and 16/03/2020
market surveillance
Published on
- COM guidance on medical
03/04/2020
devices, active implantable
3. Provide for mechanisms to medical devices and in vitro
communicate between National diagnostic medical devices in
Competent Authorities and the the COVID-19 context
Commission on availability,
potential risk of shortages and
measures taken to ensure
availability of safe and critical - European standards for certain Published on
medical devices. medical devices and personal 25/03/2020
protective equipment.

- MDCG guidance on remote Published on

audits 08/04/2020

Available from 25
- CIRCA BC notification system
March 2020
of national derogations related
COVID-19

- MDCG guidance on regulatory Published on 24 April

requirements for ventilators and 2020
related accessories
5 Expert panels

- Appoint experts to panels and Art 106 1. Consultation of MDCG on 1. Finalised

publish the lists of appointed selected experts.
experts along with their CVs and
declarations.
- Publish the names of experts 2. Appointment of experts 2. By end July
included on central list of 2020
available experts.
3. Finalised
- Establish expert panels for 3. Website on expert panels
Clinical Evaluation Consultation 4. By Q4 2020
Procedure (CECP) / 4. Make available the panels
Performance Evaluation
Consultation Procedure (PECP).

6 Transparency

- Issue a fact sheet on information Art 33 Document needed by Member States Finalised
to become publicly accessible when MDR becomes applicable. July 2020
when EUDAMED is in place.

7 Reprocessing single use devices

- Common specifications through Art 17(5) In light of MDR application date By Q3 2020
Implementing Act. postponement, IA can only be
applicable for May 2021, but should
be adopted asap to facilitate for MS to
adopt national rules.
8 Standardisation
Adopted on 15 May,
1. Standardisation Request to CEN Art 8(1) Legal basis as per the rejected by
/CENELEC to review or update Standardisation Regulation (EU) CEN/CENELEC on
the existing harmonised standards 1025/2012 for harmonised standards 16 June.
on medical devices and to draft and the publication of their New procedure to be
new standards in support of the references in the OJ. launched for possible
MDR/IVDR through adoption from Q1
Implementing Decision. 2021

Harmonised standards conferring From Q1 2021

2. Publication in the OJ of lists of presumption of conformity to (depending on a new
references of harmonised facilitate the conformity assessment Standardisation
standards in support of the of devices and their certification. Request)
MDR/IVDR through
Implementing Decisions.