The modernization and expansion of medical device regulations has prompted new challenges for EU nations, which comes as no surprise considering medical devices generate annual sales of approximately EUR 95 billion and provide jobs for more than 500,000 people in the EU. However, the term “medical devices” actually roughly describes more than 500,000 products in the EU, accounting for about 33 percent of the world market.
For the past 15 to 20 years, there have been three directives that govern these devices, which have been modified several times to expand obligations for long-term safety surveillance, strengthen some clinical data requirements and clarify that medical-related software is considered to be a medical device.
During our recent webcast, “Navigating the Challenges of the Modernization and Expansion of EU Medical Device Regulations” attendees were asked: Under which directive(s) do you currently have medical devices governed and/or will be seeking governance for a medical device going to trial?
The results of the poll:
- 51 percent: Medical Device Directives (MDD)
This includes any device used for “the diagnosis, prevention, monitoring, treatment, or alleviation of disease” that does not act by pharmaceutical means. Examples: dental filling materials, bone plates and screws, dialysis equipment
- 17 percent: In Vitro Diagnostic Device Directive
This includes any device intended “to be used in vitro for the examination of specimens… derived from the human body.” Examples: pregnancy tests, therapeutic drug monitoring, genetic testing for markers of disease or susceptibility to certain medications
- 10 percent: Active Implantable Medical Device Directive
This includes any device that is intended to be placed inside the body, remain after the procedure, and rely on a power source “other than that generated by the human body or gravity.” Examples: implantable defibrillators, deep-brain stimulator
- 17 percent: All of the above
- 5 percent: None of the above
The proposed legislation hopes to condense these three directives into just two directives: One that covers medical devices and active implantable medical devices (a combination of the current MDD and AIMDD directives) and another that addresses in vitro diagnostic medical devices (similar to the current IVDD directive). However, it will also provide a wider and clearer scope of devices; clearer rights and responsibilities for manufacturers, importer and distributors; better traceability of devices; and much more.
Download the slides for more information on current and future medical device regulations. If you’d like to be alerted to an upcoming ebook on updated EU medical device regulations and their expected impact, please leave your contact information in the comments section.