Regulatory affairs, in practice

How a regulatory information management platform handles global registrations — centralised data, standardised submissions, and tracking requirements across markets.

One of the hardest parts of developing a new device is determining exactly how to proceed with regulatory pathway, especially in the case of devices where initial assessments indicate multiple potential classes or uncertainty around clearly-defined class.

Essenvia CEO Soumya Mahapatra answers three common objections to RIM platforms: the cost, the disruption to existing workflows, and how long benefits take to appear.

Part two of a two-part series: regulatory experts on how the EU MDR transition has affected device innovation, and what it has cost manufacturers.

Part one of a two-part series: regulatory experts on whether MedTech regulation accelerates or obstructs device innovation — and when it does each.

When the US Food and Drug Administration’s (FDA) new Quality Management System Regulation (QMSR) comes into force in early 2026, medical device manufacturers run the risk of falling down if they failed to start the process of updating standard operating procedures (SOPs) for quality systems right now, industry experts advise.

Reviewing and updating standard operating procedures (SOPs) for quality systems should be top of mind for medical device manufacturers so they’re in compliance with the US Food and Drug Administration’s (FDA) new Quality Management System Regulation (QMSR) when it takes effect in early 2026.

The ever-evolving world of medical device regulations presents an era of continuous change, most notably with the EU’s Medical Device Regulation (MDR). Industry experts warn that noncompliance with the rule’s requirements could land MedTech manufacturers in hot water.

Achieving regulatory excellence involves...

Regulatory Excellence is a crucial aspect of the Medical Technology industry, which involves complying with strict guidelines, ensuring procedural accuracy, and aligning strategically to navigate the complex landscape of compliance and approvals.

Regulatory Excellence encompasses the adherence to stringent guidelines, procedural accuracy, and strategic alignment necessary for navigating the complex landscape of compliance and approvals within the MedTech industry.

Different policies and submission procedures across countries and regions create a significant barrier to meeting regulatory deadlines and can easily become an intricate puzzle if there is not a centralized Regulatory (RIM) Platform to merge and automate all regulatory processes and data.

Navigating regulatory implications when making changes to medical devices is critical to ensuring compliance and market readiness. The evolving landscape demands a keen understanding of regulatory processes, especially in the United States, where the FDA oversees market entry through rigorous evaluations.

Class III PMA (pre-market approval) has a lot to offer for companies. In addition to getting clear approval for a device, Class III PMA also offers product protections similar in many respects to a patent, making it highly desirable.

Step by step through the FDA eSTAR process: eligibility, attachments and the 4 GB limit, the required forms, and what happens at technical screening.

How to ask the FDA a question that gets a useful answer — with before-and-after examples of Pre-Sub questions on biocompatibility, De Novo and predicate choice.

Implementing a RIM platform can significantly enhance regulatory processes. However, several misconceptions often prevent medical device companies from adopting these platforms. In this webinar, we debunk the most common myths and demonstrate how RIM platforms can quickly generate ROI.

How to rapidly transition to FDA's mandatory eStar submission process.

Regulation vs. Innovation in the medical devices industry represent an essential and never-ending balancing act and dance that must play out. In this roundtable webinar, four longtime MedTech industry experts will dissect and discuss challenges manufacturers face as they work to comply with rules and regulations.

How eSTAR works: what the template does, the two ways to submit, what you no longer need to include, and where submissions still run into trouble.

What MDCG-2022-21 means for IVD manufacturers: who must file a PSUR under IVDR Article 81, what it contains, and how legacy devices are treated.

You can document Risk in a 510(k) by comparing subject device with one or more similar legally marketed devices to support substantial equivalency claims. To legally market your medical device, you need to demonstrate it is as safe and effective as any other legally marketed product that is not subject to PMA (21 CFR 807.92(a)(3)). The blog describes key factors for documenting risk management in 510(k) submissions.

If a manufacturer plans to distribute a medical device to the market in the United States or Europe, the company must first ensure that the device is in compliance with each target region’s medical device classification requirements.

Launching a new medical device is a highly regulated process whether you are looking to sell in the United States or other countries. To go to market within the European Union, you must first obtain a CE mark for your medical device. Please keep reading to learn about what a CE mark is, why it’s important, and how to get one.

When manufacturers plan to launch a medical device into the United States market, one of the most crucial steps is obtaining FDA clearance.

Establish conformity with these requirements and should provide sufficient evidence to demonstrate compliance with GSPR. GSPR is a core element to navigate CE marking for a device.

Medical devices in the US (and the rest of the world) use a risk-based classification system that determines the rules and regulations and level of evidence necessary to obtain FDA permission to market a new or modified medical technology.

Medical device manufacturers who intend to introduce a device into commercial distribution in the United States must submit a premarket notification – 510(k) or PMN to the FDA.This rule is applicable whether you are introducing a device for the first time, or planning a reintroduction with significant modifications.

Why regulatory operations decide time-to-market — where manual submission assembly introduces errors, and what the FDA's refuse-to-accept rate reveals about them.

First, you conceptualize your idea for a new medical device. Your team has determined what medical issue it is going to resolve and how it will be used. Then, you research the current state of the market to understand the level of need and how to best position it.

If you have ever put together a 510(k) submission, you know exactly how massive of an undertaking this project becomes.