First in a 7-part series on the EU’s Medical Device Regulation
The European Parliament passed the Medical Device Regulation (MDR) two years ago and began a three-year transition period in May 2017 with enforcement set to begin in May 2020.
The new regulation repeals and replaces the Medical Device Directive (MDD) and the Active Implantable Medical Device Directive (AIMDD), effectively pushing the reset button for medical device makers who sell products in Europe.
The new European Medical Device Regulation represents a significant shift in the EU’s approach to medical devices, and companies with MDD approved products won’t have their devices grandfathered in. More on that later.
The EU undertook the overhaul of its medical device directives because the directives law that took effect in 1992 did not cover many of the technology advances that have occurred in the last two decades. As an example, the 1992 law did not cover software as a medical device. Other considerations in developing the MDR were a growing push for making medical device technical information more transparent, broadening the scope of devices regulated and to bring more standardization to medical device regulation. In addition, the directives were subject to interpretation into local regulations, and the MDR will provide greater uniformity as it codifies the directives, as well as many previous MEDDEVs into law.
Compared to the MDD, the new 174-page MDR puts much less emphasis on the pre-approval stage and focuses much more on life-cycle medical device regulation. While the MDD served as essentially a manual for how obtain a CE mark, the new MDR places greater responsibility on medical device makers for their products throughout the product lifecycle, according to the quality management software company Greenlight Guru.
Are your devices covered under the MDR?
Under the MDR, what is considered a medical device has been expanded to include any “instrument, apparatus, appliance software, implant, reagent, material, or other article used to diagnose, prevent, monitor, treat disease or disability or injury.” Also included are any investigation, replacement, or modification of an anatomical, physiological, or pathological process. In addition devices used to provide data via an in vitro exam of samples taken from a human body.
What is not included are devices aimed at prevention of disability or injury. In other words, a broad range of existing devices are covered by the MDR plus newly specified products used to clean, disinfect, sterilize medical devices, and devices used to control or support conception.
In addition, the MDR’s Annex XVI mandates coverage of additional devices that were not previously considered medical devices. These include primarily cosmetic devices such as contact lenses or other products used in the eye including eye drops and cosmetic contact lenses.
How long can one continue under an MDD certification?
Under the implementation timeline all MDD certificates will remain valid until they expire, or until four years after the date of application (May 2024), whichever comes first. Devices issued certificates under MDD Annex IV or AIMDD Annex 4, remain valid until expiration or two years after date of application (May or June 2022), whichever comes first.
As for new applications for Class I devices the hard deadline is expected in May or June 2020, however this is NB-specific, and we have some NBs setting deadlines in 2019. Higher risk medical devices may switch to the MDR certification only when their Notified Bodies have been designated for MDR.
Contrary to common misconceptions, according to MedTechIntelligence this means that orior to May 2020 you need to have your certifications either renewed as MDD certificates or certified to MDR. It is important to note, however, that many NBs will not continue with a parallel path, so this timeframe is NB dependent. Renewed MDD certificates will allow sale of products until May 2025. All new products must be MDR compliant.
Hilde Viroux, associate vice president, regulatory at HCL America, Inc speaking at a MedTechIntelligence workshop recommended developing a working plan, understanding that this does not just affect the regulatory department. To be successful you may need to involve many different departments including R&D, quality, clinical, legal, IT, and HR. The impact on staff resources is likely to be greater than you might expect.
She said you will need to do a gap assessment to determine effort required and budget for it. Conduct a pilot phase, test partners and refine the budget and ensure that senior officers take active leadership roles, and that you work with the notified body to plan for MDD certificate renewals and MDR audits.
If you are looking for help with how MDR affects your organization, Kapstone Medical has the experience and expertise to assess your product portfolio, quality management system procedures, and design history files. Contact us for more information.
Sources: Euro-Lex Document 32017R0746; Greenlight Guru, 7 questions about the European MDR answered; MedTechIntelligence Misconceptions of EU MDR Implementation