Few companies get excited about regulations. Just the mention of new regulations might induce some groaning, sighing or eye rolling. But that mindset ignores the real benefits and opportunities regulations can open up.
Yes, we said it — benefits and opportunities.
The European Union Medical Device Regulation (MDR) that was published last year and takes effect in 2020 sets clear and stronger standards for how devices are marketed and manufactured. It requires greater scrutiny, compliance and transparency to bring devices to market, including more detailed clinical evidence, and it expands the description of medical devices to include some that weren’t regulated before, among many other changes.
Perhaps the greatest benefit is patient safety — few could argue against the need for safer products and improved transparency regarding risks. MDR is also designed to even the playing field among manufacturers, offering fair market access to all. As for opportunities, MDR sets the stage for forward-thinking companies who are early adopters to gain a significant competitive advantage.
HOW MDR WILL IMPROVE PATIENT OUTCOMES
A number of high-profile medical device failures prompted the EU government to revamp regulations, which had been unchanged since the 1990s. Headline-making hip replacement implant recalls in 2010 and a surge of breast implant ruptures in 2012 highlighted the need for regulatory changes.
The benefits to patients are many. With stricter scrutiny and more compelling medical evidence required before products hit the market, consumers can rest assured that the devices they use have been thoroughly vetted.
More specifically, some notable benefits to patients include:
- Safety standards for aesthetic devices and products such as breast implants and colored contacts that were not previously regulated
- Easy access to information about the safety records of devices and reported risks though a public database
- Assurance that manufacturers are being held to quality and safety standards as long as the product is being produced, not just when it’s released
LEVERAGING MDR FOR A COMPETITIVE ADVANTAGE
MDR regulations don’t take effect until May 25, 2020, but companies that comply early will have a significant advantage over late adopters.
More than two years might seem like a lot of time, but medical industry analysts and consultants are predicting that manufacturers who wait to begin the process might not be able to find the resources they need to meet the deadline.
Life sciences consulting firm Maetrics estimates that $16.5 billion in medical device market share will open up as a direct result of manufacturers that are not able to comply on time and, thus, exit the market for a period. That’s a huge chunk of money for early adopters to go after, and it means smaller players and newer companies have a better shot of gaining market share.
Manufacturers that are early adopters can and should market themselves this way —letting patients know that they’re fully compliant with the latest and most stringent safety standards even before the law requires it.
MDR AND LANGUAGE TRANSLATION
One of the many requirements for manufacturers under MDR is that product information is provided in the official language of each EU Member State where the device is sold, marketed or made available. This applies to packaging, labels, instructions and all technical documentation.
For companies that haven’t previously made this information available in all EU languages, this may seem like a significant task. However, it’s a task that can easily be outsourced to a professional Language Solutions Partner (LSP) — checking one item off the to-do list and speeding up the compliance process.
