What two decades of building medical devices teaches about EU MDR readiness.

Learning alongside the regulators

Simon Taylor has spent more than two decades designing and developing medical devices, from bionic hands to oncology devices, and taking them through regulatory approval. He was doing that work when the EU MDR arrived.

"I was learning the regulations at the same time as the notified bodies were learning them." — Simon Taylor

The unknown unknowns

Teams can plan the work they know about. Simon's concern is the work nobody has identified.

"My biggest worry was the unknown unknowns: the things that weren't even on my radar." — Simon Taylor

An example: the usability file

"I'd never even heard of it before." The usability file comes from the standards rather than the regulation itself. Even so, Simon is clear that "you won't get a pass without one."

Closing that gap can mean simulated testing with clinicians. "It's not a cheap or quick thing to fix."

The completeness check comes first

Before a Notified Body reviews the content of a technical file, it checks that the file is complete.

"If you don't get past the completeness check, they'll just send it back. Any delay will cost you money."

Structure matters as much as content, because reviewers work to a fixed time. "If they don't understand it, they'll say it isn't good enough."

One version of the truth

Intended purpose, intended users and patient population appear across several documents. "If you describe the principle of operation in three or four documents, you want each one to say the same thing."

Clinical evaluation needs particular care. Teams new to it often write it like a research paper, but it must follow a set structure. "It's the biggest reason people fail their audits."

Readiness starts early

Many companies treat regulation as a box-ticking exercise once design is finished. Simon disagrees.

"The proper way to do regulation is to work through it from the start of development."

For manufacturers facing the end of the transition period: "If you want to meet that deadline, you need to start now." See MDR and IVDR transition deadlines for the dates that apply to your devices.

Where to begin

A gap analysis shows what is missing, what is incomplete and what is still aligned to the old directives. For a structured checklist, read how to identify gaps and maintain readiness.

Obodux offers its gap analysis free. Request yours or start a 4-week free trial of Obodux.

Regulatory responsibility remains with the manufacturer.