Medical Device Regulation: One Year On
The Medical Device Regulation (MDR) entered into force on May 26th 2017. Since then, it has been the focus of almost all relevant medical device conferences and training institutions, including LinkedIn groups, webinars and internet blogs.
What do all of them have in common? If you come to the MDR implementation details, there are more questions than answers. But why?
Regulatory affairs is not black-and-white, but a grey-area that is based on experience and interpretation by the notified bodies and competent authorities. Simply, this experience does not exist yet.
In addition, some requirements of the MDR are not 100% clear regarding how and when they will be implemented, including the Medical Device Coordination Group (MDCG) and sub-groups, expert panels, validity of the MEDDEV guidance and common specifications.
The industry will not see what the MDR’s real life expectations are until the remaining notified bodies (having been successfully designated for the MDR) will issue the first MDR certificates. At the moment, full MDR compliance is still a moving target.
When do we need to comply?
Generally, the transition period for MDR ends in May 2020. This means that already 33% is over.
If you get one of the last Medical Device Directive certificates for your product, you may be allowed to market it until 2025 (depending on the validity period of your certificate). However, medical device manufacturers taking this option are not allowed to change their device design, leading to a high risk of being forced to implement design changes (for example by PMS feedback) and losing the product.
The MDR does not include any grandfather provisions. Even well-established medical devices such as technologies that have been on the market for decades need to comply with MDR.
The most important changes
Some of the most important changes that will come with MDR, include:
- More stringent requirements on clinical evidence (it will become harder and harder to survive without your own clinical data)
- Scope expansion (although the definition of medical devices has not changed substantially, some products now fall into the scope of the MDR that did not before)
- Implementation of unique device identifiers (UDI)
- Identification of a person responsible for regulatory compliance ( a completely new function)
- More extensive surveillance by notified bodies
- Reclassification of devices (this will be of especially high impact if the device is reclassified to class III)
- Higher requirements on technical documentation, including additional requirements on technical files, post-market surveillance (PMS) documentation
Awareness and impact
Most of the medical device organisations are aware of the regulatory change. However, new products (especially those not being launched before 2019/2020) will directly fall into the MDR scope, as they will not get a Medical Device Directive certificate anymore and therefore need to comply in 2020.
The regulatory efforts are expected to raise leading to a high impact, especially on small-medium enterprises (SME). It is crucial to identify the gaps according to the MDR as soon as possible, and to review the respective business case for the portfolio.
What can I do now?
anteris medical recommends that you start your gap assessment as early as possible. Consider aspects such as whether your product will be re-classified, if your conformity assessment route will change substantially, and if you have sufficient clinical evidence.
Anteris medical and anteris diagnostics are able to support you in all areas of this challenging project.
The companies offer effective project management, tying together your internal organisation, development partners, suppliers and notified bodies. They are life sciences and engineering majors with dozens of years of experience in CE marking, 510(k) submissions, and quality systems regulations in all major markets.