2020 JALEX Medical Newsletter


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MED TECH OUTLOOK
JALEX Medical
Service Spotlight

JALEX Medical
Helping During the COVID-19 Crisis
The JALEX Medical team has been busy helping Clients from around the globe during the COVID-19 pandemic. From helping Clients understand the Emergency Use Authorization requirements and qualifications, to taking those innovative ideas and turning them into a functioning device our team is here to help.

On the 17th of April, the European Union voted to postpone its Medical Device Regulation (MDR) , which is a set of regulations for medtech firms to adhere to.

It had been set to come into effect on May 26, 2020, replacing the existing Medical Device Directive (MDD), but will now be scheduled for the same date next year.
This decision was taken to allow the European medtech industry to cope with the impact of the COVID-19 crisis.

GlobalData estimates that the MDR would have disrupted the approval process for many new medical innovations, as well as, the re-certification of existing devices. The postponement of these regulations is likely to have taken the pressure off many companies within the industry.

As the outbreak has heightened demands for certain devices, postponing the MDR ensures market disruptions for critical devices is limited.
UDI requirements

On June 30, 2020, the FDA issued an immediately-in-effect guidance on its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022.
Design Engineering

Biomedical design engineers to support you from concept through every stage of development.

Guidance to assist you in meeting every standard and regulation to secure your pathway to success in the US or abroad.

Guidance to define your quality objectives and develop the deliverables to integrate quality into all facets of your project.
JALEX Medical, LLC | 216. 307.6299
lbartos@jalexmedical.com