[NEWSLETTER] | [MONTH 20XX] | [ISSUE X]

MEDICAL DEVICE

REGULATORY
UPDATES
UPDATES

Published MDGC Guidelines

There are several guideline documents published by MDCG that have an impact on the industry. Please follow this link and perform an impact
assessment on your organisation.

COVID-19 Updates
A list of COVID-19 essential Medical Devices (MDs and IVDs) is now available. Please follow this link to find out the details. European standards
for medical supplies are made freely available to facilitate increase of production. For more info, please follow this link.

IN THIS ISSUE

What is the State of Play of the Implementation of EUDAMED?

The development and implementation of EUDAMED is a high priority for the Commission. The Commission, in agreement with the Medical Device
Coordination Group (MDCG), is going to make available the different modules on a gradual basis as soon as they are functional. The module on
Actor registration will be the first module made available. Deployment of the module takes place in December 2020. The module on UDI/device
registration (second module) and the module on Certificates and Notified Bodies (third module) will become available by May 2021. Afterwards,
the remaining modules will be displayed as soon as they are functional.

UDI
By implementing Decision (EU) 2019/939 on 6 June 2019, four issuing entities were designated able to provide manufacturers with a list of UDIs
to assign on medical devices. In addition, the EU Commission has published a FAQ on UDI. To view, please follow this link.
 LATEST
REGULATORY
UPDATES
NEWS
UPDATES
Medical Device Class I and Actor Registration in Sweden
On May 26, MPA in Sweden opened an e-service for manufacturer and/or authorised
representatives located in Sweden to register themselves and their devices. Please follow this link
for further information. Note the deadline of 30th September 2020.

Guidance on MIR and Updated MIR Form

The European commission published a Q&A on implementation and use of the 1st version of MIR
form. The form is updated. Please download the latest version on the links below:

• MIR version 7.2.1 (PDF)

• MIR version 7.2.1 (PDF for Excel import)

Other European Commission Publications

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• Instructions for Use for Reusable and Re-sterilisable Medical Devices. See link.
• Follow this link for the fact sheet on MDR requirements for transparency and public
information. The fact sheet lists information which will be available to the public in
accordance with transparency obligations in MDR considering that some requirements will
be applicable only once the European Database on Medical Devices (EUDAMED) is fully
functional.
• Expert panels have been designated by means of the Commission Implementing Decision
(EU) 2019/1396 in relevant medical fields. Get to know them through this link.

BUSINESSDEVICE
MEDICAL ASSURANCE
REGULATORY
INNOVATION
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NEWS| SEPTEMBER
| MARCH 2020
2020 2
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