Understanding the Impact of the EU Medical Device Regulation (MDR) on IFUs

With the deadline for the implementation of the new Medical Device Regulation (2017/745) approaching, many life sciences companies, in particularly medical device manufacturers are in preparation mode. Executing a current state-analysis is the first step, but many companies are still unsure about what it is that’s changing and to what extent these changes will affect their current processes, content and products.

The EU MDR will replace the current AIMDD (Active Implantable Medical Device Directive) and MDD (Medical Device Directive)
and by May 26, 2020 all medical device manufacturers will need to be compliant.
(The European Commission postponed the MDR Deadline for one year, to 26 May 2021, to give medical device companies a chance to focus on the current COVID-19 pandemic)

Uncertain on how to proceed and implement these changes, Argos Multilingual, as a leading life sciences translation service provider has gathered together content prepared by medical regulatory experts to help address their clients’ main concerns and alleviate their pressing questions surrounding the new regulation.
Their latest publication, “EU MDR Requirements for Instructions for Use” focuses on the impact that the EU MDR will have on Instructions for Use (IFUs). The whitepaper identifies the requirements within the MDR document, that specifically affect IFUs and provides recommendations on how to satisfy the given requirement to continue to be compliant. The publication is available on Argos Multilingual’s latest website – mdreurope.com.

This website is an agglomeration of content specifically focused on the Medical Device Regulation. By signing up once, users get access to all the resources on the website, which include:

• EU MDR Requirements for Instructions for Use
• EU Medical Device Regulation and Languages Q&A
• Regulatory Language Requirements for Medical Devices in the European Union
• The 2017 EU Medical Device Regulations Under the Microscope

For more information and to access these EU MDR resources, visit www.mdreurope.com.