Member Submission: Medical Device Regulation

Introduction from Todd J. Albert, MD, SRS President 2017-2018:
In May 2017, the new Medical Device Regulation (MDR) was published in the Official Journal of the European Union marking the start of a new era of regulatory policy for medical devices in Europe. In this issue SRS member Bill Horton, scoliosis surgeon and a member with experience in industry helps explain the implications of this changing regulatory landscape.

 

As an international organization, SRS seeks to keep members updated on global events that may impact our Society, individual members, and our patients.  In May 2017, the new Medical Device Regulation (MDR) was published in the Official Journal of the European Union, marking the start of a new era of regulatory policy for medical devices in Europe that may directly or indirectly impact our membership, SRS, our sponsoring industry partners, and most importantly may affect access to new innovation for some patients.   

The MDR introduces a new regulation across the EU for getting a device or implantable technology approved for clinical use and to maintain its availability to patients over time.  While these changes have been contemplated for years, recent high-profile safety challenges in Europe (e.g. breast implants or metal-on-metal hip implants) have helped propel the process and shape the new environment.  MDR is aimed at strengthening the regulatory framework for medical devices and is expected to have a major impact on the entire medical device industry, introducing new and substantial requirements. Among the goals of the MDR are (1) to improve patient safety and access to relevant device information, (2) increase the evidence required to establish device safety and performance, and (3) increase public access to information that provides assurance of safety, performance and high quality.   

The MDR, which replaces the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMD), spans the entire EU and has a transition period of three years, so the effects are starting now and will peak by 2020 as manufacturers work to update their technical documentation and processes to meet these new regulations. Examples of some new requirements in the MDR include (1) more enforcement of advertising and labeling claims, (2) prohibition of reprocessing of single use devices, (3) inability to gain regulatory clearance by using an “equivalent” competitive predicate device, (4) substantially greater  clinical evidence requirements for approval and enhanced post-market surveillance with clinical data,  and importantly (5) the potential up-classification of meshes and devices in contact with the spinal column, the heart or central circulatory system.  The MDR requirements also impact other key stakeholders like importers, distributors, Notified Bodies and National Health Authorities.   

How could this possibly affect you or your patients?  Here are a few examples:

1. In the EU, MDR will make it much harder to bring new devices into the market so there may be longer delays to introduce a new technology. Some devices currently available may not remain available in the future if the manufacturer cannot generate sufficient data or justify the added expense of meeting the new requirements.
2. Due to the increased need for clinical data in the future, both surgeons and patients in the EU will increasingly be asked to participate in EU clinical studies now being required for regulatory approval. There will likely be increasing opportunities to participate in clinical studies, and your hospital or clinic may be recruited to gather data either for new approval studies or ongoing post market surveillance. Patients will need to cooperate with this increasing data collection as well, and lack of surgeon or patient participation may jeopardize access to innovation. There is still discussion among Regulators globally about the potential to leverage data from other regions of the world, which could theoretically affect both surgeons and patients from non-EU countries in the future.
3. Device companies now face significant increase in costs for these new clinical studies and requirements, which could result in effects like - (a) increased cost for some devices, (b) withdrawal of certain devices from the market, (c) smaller companies may no longer being able to support an EU market presence, or (d) there may be less industry funds available for other activities like Professional Education or general support of professional Societies.
4. For any surgeons globally who are involved in product development, the new MDR requirements and costs should be realistically considered as part of the effort and  investment necessary to gain approval and maintain a product in the EU market.
5. Certain devices like spinal cages now potentially face up-classification which means that new burdens of proof may be required to maintain these in the EU markets. The details of this is still being debated, but if it is enacted, this may impact the ability to promote or teach these techniques as “approved” or “on label’ in the EU. Paradoxically, this trend follows shortly after the FDA has recently down-classified devices like these in the US.

The MDR ultimately seeks to improve patient care, transparency and safety - which are goals we all support. One of the positive outcomes of this will be a growing bank of clinical data regarding the safety and effectiveness of devices and treatments.  Challenges may arise with the implementation and resources required as regulators, industry, and the entire medical community work through the transition up to 2020. There are some benefits and drawbacks that may affect SRS and our membership either directly or indirectly, and this information regarding MDR is provided to inform our membership and raise awareness. If you would like further information please contact Shawn Storey, Website & Program Manager, at [email protected] or visit the Official Journal of the European Union website (e.g. REGULATION (EU) 2017 – EUR-Lex).