Talk about the fundamental changes coming to European medical device regulation has been buzzing through the industry for the past several years. Medical device firms across the globe have been preparing themselves for changes to their regulatory compliance strategies in efforts to qualify for selling into the European market after May 26, 2021.
On May 26 the new Medical Device Regulation (MDR) will replace the previous Medical Device Directive (MDD). The goal of the new law is to provide a consistent and fair regulation to all participating states that will increase standards for quality and safety measures related to medical devices being offered for sale in the EU.
The MDR includes all 27 members of the European Union – excluding the post-Brexit United Kingdom – and includes guidelines designed to encourage medical device companies to become more proactive and improve their overall standards to help boost product safety. All of these enhancements and improvements come at a cost: MDR documentation is four times longer than the previous MDD rules required. This is mostly because the new regulation does not technically replace the MDD, it actually adds some further requirements, including requiring companies to improve their portfolios and implement the newly-required changes in order to remain in compliance with the enhanced regulations.
Was this change necessary?
The short answer is “yes.” The MDD was signed into law almost three decades ago when technologies such as medical device software were just being introduced. Today, significant numbers of devices are software-controlled and even “smart.” The downside to this is increased patient risk presented by potential software glitches.
This concern is compounded by the increased average age of Europeans, thanks in large part to improved medical care. With advancing age comes increased risk of complications and even death as a result of device malfunction and possible product hygiene safety degradation. For this reason, the MDR has put stricter regulations on product lifecycles and will require improved medical device technical information for greater consumer transparency.
Have testing properties changed as a result?
Yes. The MDR contains an amendment of the DIN EN ISO 10993, which includes 20 independent guidelines to help regulate the chemical and biological analytics of products. ISO 10993 now clearly indicates that in vitro test systems have to be preferred over animal studies whenever possible and that manufacturers must assess the biological safety of the defined medical device during its entire life cycle. Reusable devices have to be assessed according to their validated application cycles.
The good news is that the MDR is not dramatically different from the MDD because the law has been continually updated while the MDD has been in effect. Most of the changes are stricter regulations and enhancements of already existing rules.
What is new, however, are the following rules:
- At least one person within an organization is required to ensure its regulatory compliance (fortunately, most companies already have a quality, regulatory compliance, or safety manager – now it is required).
- Products without an intended medical purpose are also included in the MDR, as specified in Annex XVI, which covers items intended for cosmetic purposes, raising concern among cosmetic manufacturers.
It is difficult to cover all of the details of the changes introduced by the MDR in a blog post. If your company would like help with post-MDR transition compliance, please contact us here at MEDIcept.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.