Release date: 23.07.2020
Newsletter
MDR/IVDR – what’s new?
As preparations continue for the application of the new medical devices Regulation (MDR) and in vitro diagnostic medical devices Regulation (IVDR), we strive to keep you up to date on all relevant news and events. Furthermore, as medical devices are particularly relevant in the fight against the COVID-19 pandemic, this newsletter also aims to keep your finger on the pulse of all the latest developments related to medical devices within the context of the pandemic and efforts to manage it and mitigate its impacts.
In this issue:
European Commission launches new Medical Devices site, hosted on DG SANTE portal
EC publishes list of COVID-19 essential medical devices
CEN publishes free Workshop Agreement on community face coverings
European Commission (JRC) makes IVD performance database available
Conformity assessment procedures published for protective equipment
Commission issues notified bodies state of play
State of play issued for Joint Implementation Plan
Notified body capacity survey results published
EC guidance on regulatory requirements for medical face masks
Guidance issued on devices in the COVID-19 context
Guidance on ramping up production of essential equipment
New Medical Devices website launched
The European Commission has launched a new Medical Devices website, hosted on the portal of the Directorate-General for Health and Food Safety (DG SANTE).
The website contains information and advice for all stakeholders in the medical devices and in vitro medical devices value chain with respect to their roles and responsibilities within the context of the new medical devices Regulation and in vitro diagnostic medical devices Regulation.
Previously hosted on the website of the Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW), the site has been updated to contain new information related to the impact of the COVID-19 pandemic.
To visit the website, click here.
EC publishes list of COVID-19 essential medical devices
The European Commission has published a list of medical devices and in vitro medical devices deemed essential in the context of the COVID-19 pandemic. This list may be used as a guide by notified bodies when considering which products to prioritise for conformity assessments.
For the full list of essential COVID-19 devices, click here.
CEN publishes free Workshop Agreement on community face coverings
In light of the evolving situation with the coronavirus outbreak in Europe, CEN - the European Committee for Standardisation - has developed a new CEN Workshop Agreement on community face coverings (barrier masks).
The new Workshop Agreement provides guidance on the design, production and performance assessment of single or reusable community face coverings intended for consumers. It is available to download for free from the CEN and CENELEC website and from the websites of CEN national members.
For more information, click here.
European Commission (JRC) makes COVID-19 IVD performance database available
The Joint Research Centre, the European Commission’s in-house science service, has made available a ‘COVID-19 In Vitro Diagnostic Devices and Test Methods Database’. The objective of the database is to collect in a single place all publicly available information on the performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in-house laboratory-developed devices and related test methods for COVID-19.
For more information, click here.
Conformity assessment procedures published for protective equipment
The European Commission has updated the set of Q&A guidance outlining conformity assessment procedures for personal protective equipment and medical devices within the COVID-19 context. Targeted at prospective manufacturers of medical and protective equipment, the document outlines the applicable EU legal frameworks for these products along with the mandatory EU standards that should be followed during production, in addition to other important information.
The document will continue to be complemented on a regular basis in order to address any additional questions or concerns expressed by the economic operators.
For the full Q&A, click here.
Commission issues notified bodies assessment state of play
The European Commission has issued a state of play of the joint assessment of notified bodies in the medical devices field. Updated on 13 July 2020, the state of play provides as overview of notified bodies at each stage of the designation process, along with the number of notified bodies to apply for designated status, and other information.
To view the state of play, click here. For a continuously updated list of the designated notified bodies, check the NANDO Information System.
State of play issued for Joint Implementation Plan
The European Commission has published a state of play for the Joint Implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the MDR. The document provides an update on the current status of EUDAMED, clinical evaluations, transitional provisions and much more.
To read the document in full, click here.
Notified body capacity survey results published
The European Commission has released the results of a survey conducted in May this year to assess the capacity of notified bodies to perform conformity assessments for medical devices and in vitro medical devices related to the diagnosis and treatment of COVID-19. These results can be used as a guide by device manufacturers and other stakeholders.
For the results of the survey, click here.
EC guidance on regulatory requirements for medical face masks
The European Commission has issued guidance on regulatory requirements for medical face masks under the Medical Devices Directive 93/42/EEC and Regulation (EU) 2017/745, outlining options for supporting production and/or placing on the market of medical face masks in the context of the COVID-19 pandemic.
Under the current COVID-19 context, the demand for different types of face masks has rapidly increased. Therefore, this document intends to outline the regulatory options for the placing of medical face masks on the EU market indicating their feasibility to allow short-term supply.
For more information, click here.
Guidance issued on devices in the COVID-19 context
The European Commission has issued guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 context.
This guidance explains the legal requirements for placing such medical devices on the EU market, how standards can be used under the current legislation and whether it is possible to derogate from the normal conformity assessment procedures in light of the urgency caused by the COVID-19 outbreak.
For more information, click here.
Guidance on ramping up production of essential equipment
The Commission has made available guidance to assist manufacturers in ramping up production of essential medical equipment and material in three areas: the production of masks and other personal protective equipment (PPE), leave-on hand cleaners and hand disinfectants and 3D printing in the context of the coronavirus outbreak.
These documents also aim to assist manufacturers and market surveillance authorities in making sure these products comply with necessary safety standards and are effective.
For more information, click here.
Stay tuned for future updates!
To stay up to date on all information related to medical devices and in vitro medical devices within the context of the new Regulations make sure to visit the Medical Devices section on the Commission website regularly.
There are also some new factsheets and other resources in the pipeline to help you prepare for the application of the MDR and IVDR. We will keep you informed about these and other important developments, so stay tuned!
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