An EU and US perspective on recent study on device regulations

A simplified regulatory and device tracking process—an EU and US perspective.

Recently Pepgra Healthcare has reported findings on two unique trends (8 months: January through August of 2018), pertaining to tracking or tracing the medical device and a much easier process of regulations for the low-risk category of devices.

Occasionally, we review all the regulatory changes and trends. According Pepgra CRO experts, members at the “IMDRF” (The International Medical Device Regulators Forum/Association) are working industriously to enhance coordination among regulators of medical device manufacturers.

Medical device monitoring, tracking & tracing—PMS

We all know that overall there is a priority on data collection (entire product life-cycle) including implementations pertaining to online, digital, and regulatory affairs that foster collection of data for specific devices that are market delivered. These efforts include adoption of a global naming convention. We can develop a thesis report from this topic.

In the past few months from January through June 2018, there has been strides to accelerate the GMDN process (Global Medical Device Nomenclature) for harmony across the world to ensure easy reach of the codes.

FDA did incorporate “GMDN” descriptions in “GUDID” albeit the figures vary and no the same as the real figures; however, when it comes to EU’S case, members of EU legislation had mentioned in the draft law about the GMDN codes and then removed it post-publication in 06/2017.

Regulations in USA—Food and Drug Administration

When it comes to GUDID and UDI, the Food and Drug Administration had The FDA had actually surpassed other regulatory bodies with stringent requirements of legislation; moreover, after launch of 2.3.2 (GUDID), Food and Drug Administration moved to an eminent position and of these changes the important aspect was to add PMA (Pre-market approval) along with 510(K) clearance figures linked to the entries. Pepgra CRO experts observed that this is was not done hitherto and this is the first time they (device models) are associated with 510(K) and that too systematically. In addition, those who apply from the US who do regulatory study and research on other manufacturer’s medical machines or their own ones ponder about the trajectory of device because it is now well documented.

Regulations in EU— UDI, and EUDAMED

Let us be clear that UDI and EUDAMED are the EU versions of the FDA’S UDI and GUDID; furthermore, the EU’s MD regulation (2017/745) has an application date of 26-05-2020 (two years from the date of this blog post) and propagates UDI and EUDAMED. Toward this objective the MDCG and COMM have made strides with both of them

Here are couple of things Pepgra CRO experts have noted:

• By 04-2018, the European Union accepted both the EUDAMED test sessions for the actor registration module, EU UDI Work Group, MDCG guidance reports on UDI. This also entails medical device classification in the future.
• Per Article 34(1), the EU COMM has shared the enactment plan for functional specs of EUDAMED prior to the 05- 2018 database launch target.

Device traceability plays an important role today and various regulators are building mechanisms for this task and all regulators are striving toward launching a system for this task. Identification, nomenclature, UDI—these are some of the approaches that the systems require. IMDRF is assisting these tasks in addition to supporting compatibility of regulators’ sites.

Class I devices: less cumbersome regulatory process

Regulators generally develop a regulatory system where requirements are proportionate to the risk of the medical device. The US FDA and the EU regulators advocated regulatory systems where the lowest-risk medical devices have largely depended on a notification system (Class I and Class I self-certified, respectively). There are of course other countries’ regulatory regimes that implement analogous systems as well.

Pepgra CRO experts have noted that some regulators initially propagate their early-stage systems with stringent requirements for even the lowest-risk medical devices. As experience and confidence in the function of the system improves, the system evolves. The lowest class of medical devices now have a considerably simplified regulatory process.

Tread the EU and US regulatory terrain with ease; talk to Pepgra CRO experts today.

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