IIb, or not IIb: that is the question for the European Union Medical Device Regulation
Work in progress, please don’t forward, and please consider reading other articles first.
6 minute read.
“To be, or not to be: that is the question” from Hamlet, Act III, Scene I.
IIb, or not IIb, is a question companies will face for the new European Union Medical Device Regulation when classifying a medical device to sell in Europe: devices are classified as I, IIa, IIb, or III, and this apparently simple choice has ramifications that will impact a company’s efficiency and work culture for many years. More importantly, device classification is critical for protecting patient safety.
This article summarizes the impact of choices for the MDR and links to articles for deeper dives into topics. To keep it interesting, for me at least, I base all points from Shakespeare quotes.
“Though this be madness, yet there is method in it.”
-Hamlet, Act II, Scene II.
The European Union Medical Device Regulation is longer than a Shakespeare play, 175 pages and over 191,000 words. It governs how countries in the EU will respond to medical device companies, how auditors will ensure compliance, and how companies can ensure their products are available for sale to 500 million European citizens.
The MDR came from public demand after previous requirements failed to protect patient safety, especially a case where 400,000 people received toxic implants from a single company.
The MDR is available for free download from the EU, or as a user-friendly file from a consulting company, Oriel STAT-A-MATRIX. All information is in the MDR, and my blog has articles that hopefully simply some of the less-obvious concepts.
Classifying a device is the first step in complying with the MDR. The extent of paperwork and corporate resources necessary to comply grows with each classification, with Class I being the simplest to Class III requiring extensive resources to monitor and report medical device safety. Classifications are broken down farther, such as Class IR, IM, etc, but the most drastic change occurs between Class IIa and Class IIb. This is because the European Union allocates more resources to monitoring medical device safety for higher-risk devices, and, in the past, loopholes allowed companies to take the easier route.
For the new MDR, Class IIa devices must update safety reports every two years, or as necessary if field reports indicate a safety concern, but Class IIb must be updated every year, or as necessary. The extent of reporting also increases, with Class IIb requiring more post-market surveillance. This isn’t just another form, it’s a proactive, dedicated approach to reducing risk by actively seeking new information and continuously updating assumptions in a company’s risk-management file, ensuring that information is linked to all departments especially product design. Every year a company must demonstrate that all IIb devices are continuously improved to reduce risk as far as possible when compared to competitive products and alternative treatments.
This is huge! As a consumer, wouldn’t you hope that your healthcare were dependent on state-of-the-art safety rather than marketing or large contracts based on cost-cutting?
As a medical device professional, you can help your company and society by understanding the classification rules and consequences of this initial step. To help, I created a classification game based on another literary achievement: Celebrity Jeopardy.
“The first thing we do, let’s kill all the lawyers.”
King Henry the Sixth, Part II, Act IV, Scene II
A lot of the MDR was written by lawyers, not healthcare providers or medical device professionals. By no means do I condone violence, even for lawyers. In fact, I love the law and believe that it creates fair boundaries, or fences, and that “good fences make good neighbors” (Frost, Mending Fences”) But, the language used by lawyers can seem frustrating.
For example, the phrase “state of the art”is used 17 times in the MDR but is never defined. I researched how and why, realizing that the MDR was formed by European lawmakers used to the Napoleonic Code of law, which uses “state of the art” differently than most laypeople, engineers, or doctors. It means “generally accepted state of the art,” and this concept is critical for companies to use the MDR for increased efficiency and innovation rather than burdensome paperwork. I wrote an article summarizing how to make state of the art medical devices using another literary milestone in human history, the 1980’s television show Knight Rider.
“The devil can cite Scripture for his purpose.”
The Merchant of Venice, Act I, Scene III
The Winter’s Tale
“You pay a great deal too dear for what’s given freely”. – (Act I, Scene I).
Many consultants may try to make it seem as if only they know the answers, but all of the MDR is available online, for free, and the EU posts frequent updates and clarifications. The challenge companies often face is not knowledge, but time. You can help by learning how to search the MDR for key questions and citing official regulations rather than relying on word-of-mouth. To help, I created a tutorial on searching the MDR using one of America’s greatest poets, Chuck Norris.
Hamlet
To be, or not to be: that is the question”. – (Act III, Scene I).
“Though this be madness, yet there is method in it.”. – (Act II, Scene II).
“Brevity is the soul of wit”. – (Act II, Scene II).
As you like it
“The fool doth think he is wise, but the wise man knows himself to be a fool”. – (Act V, Scene I).
Romeo and Juliet
“What’s in a name? That which we call a rose by any other name would smell as sweet”. – (Act II, Scene II).
The Merchant of Venice
“The devil can cite Scripture for his purpose”. – (Act I, Scene III).
Measure for Measure
“The miserable have no other medicine but only hope”. – (Act III, Scene I).
King Henry the 6th, Part II
“The first thing we do, let’s kill all the lawyers”. – (Act IV, Scene II).
King Henry the Fifth
“Men of few words are the best men” . – (Act III, Scene II).
The Winter’s Tale
“You pay a great deal too dear for what’s given freely”. – (Act I, Scene I).
Troilus and Cressida
“The common curse of mankind, – folly and ignorance”. – (Act II, Scene III).
As You Like It
“Live a little, comfort a little, cheer thyself a little”
King Henry V
“I would give all my fame for a pot of ale, and safety.”
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“This above all: to thine own self be true.”