UPDATE ON EU MEDICAL DEVICE LEGAL FRAMEWORK from buzai232's blog

UPDATE ON EU MEDICAL DEVICE LEGAL FRAMEWORK

Degraded confidence in the safety of medical devices across the EU is noted as the leading cause of the upcoming changes to the regulatory framework for medical devices.Get more news about medical device translation services,you can vist our website!

The dip in EU regulatory confidence also coalesces with, and is partly caused by, technological advancements in the medical devices field.

Technological advances in the industry have expanded far ahead of the EU’s regulatory framework which, legally, has remained static for the better part of two decades. With this regulatory overhaul, the EU hopes to alleviate safety concerns and reclassify devices to better harmonize with international markets.

Updating regulations will also bring with them a renewed need for medical device translation. Compliance with EU regulations through the coveted CE mark will necessitate proper understanding and implementation of the new rules, requiring medical device translation services for labeling, registration, and packaging.
The new measures focus on two general mandates: addressing pre-market device safety and increasing device traceability after market entry. The regulations adapted this year signal a lack of appropriate safety guidelines over the past two decades and the archaic nature of the EU’s previous guidelines.

Illustrative of this problem is the long stretch of time which has passed since significant updates to the regulatory framework were last made. The last councils and directives on EU medical devices law were held in 1990, 1993, and 1998 with each round of councils applying to a single category of medical devices.

The 1990 council regulated active implantable medical devices while the 1993 and 1998 councils addressed Medical Devices and in Vitro Medical Devices (IVDs) regulation respectively

Medical Devices can be anything from x-ray machines to hip replacements while In Vitro Medical Devices are generally used to test bodily fluid samples in order to acquire diagnostic information.

Altogether, Medical Devices and In Vitro Medical devices make nearly 500,000 devices on the market. Every one of these devices, will, at the very least, require language adoption in labeling over the next three and five years.

WHAT’S CHANGING AND WHERE DOES MEDICAL DEVICE TRANSLATION COME INTO PLAY?
Perhaps the biggest change comes to the regulatory framework itself which used to cover three different legal documents but now only covers two. In Vitro devices will have their own legal document, In vitro Medical Diagnostics Regulation, while active implantable devices as well as non-diagnostic medical devices will be covered by the Medical Devices Regulation.

The new regulations particularly affect In Vitro Medical Devices (IVDs) as they are branded for use by laypersons and medical professionals.

Among major changes noted below, medical device manufacturers will likely need to undergo a full review of their devices – even those that have been on the market with CE marks for some time – to ensure they are fully compliant.

Medical device documentation translation plays a major role in this review, as any information that will be used by the general public or doctors in multi-lingual markets will need to have updates reflected in all the languages it’s available in.