Navigating the regulatory landscape for medical devices today
Markus Sebastian discusses the importance of regulating clear aligners and ensuring their quality for patients.
The ongoing advancement of medical technologies is leading to exciting improvements in patient outcomes, safety and efficiency.
Alongside these technological advancements, new legal, regulatory, and commercial guidelines for manufacturers have also evolved to keep pace.
Back in 2008, the European Commission issued a consultation specifically on medical devices. The objective was modernising and simplifying medical device legislation. While also developing a standard level of protection for patients.
As a result, medical device companies are duty bound to ensure that their devices are up to these standards.
The issue of regulation in the medical devices industry hit the headlines in 2010. A large medical technology company was forced to recall a metal-on-metal hip replacement system after it was discovered that wear and tear debris was causing damage and necessitating a considerable number of surgical revisions.
When the widely used metal-on-metal hip replacements were shown as defective, medical device companies found themselves facing some difficult questions about how they could prove the usability and safety of products.
Similar questions around medical device safety were also raised 10 years prior, in 2000. This was regarding the production of breast implants. It was found that Poly Implant Prothèse (PIP) had been using industrial-grade silicone rather than the medical-grade required for CE certification.
As a result, the CE mark for PIP implants was revoked. Doctors and cosmetic surgery providers were advised to stop using them.
These cases resulted in the introduction of further regulatory frameworks. The scope and reclassification of medical devices now requires a thorough review of companies’ product lines, scrutiny of liability throughout the supply chain, and a revision of regulators’ powers, which could result in additional regulatory inquiries.
Changing the clear aligner landscape
So, how does the regulation of medical devices impact our work in dentistry?
Firstly, we are seeing a growing appetite amongst healthcare professionals for the introduction of greater regulation to continuously challenge and improve the safety of medical device products – including clear aligners.
Medicines are prescribed under regulations for the patient to take. But medical devices require not only robust software and technology, but also the expertise of the healthcare professional to ensure the devices are used correctly and have the desired effect on a patient’s treatment.
The clinician makes a digital treatment plan for each single patient case. And the aligners are bespoke for each patient.
Happily, we now live in an era where the utilisation of software design and digital manufacturing enables manufacturers to create individualised orthodontic treatments. And we deliver them to patients with increased predictability. As well as less pain than previous clear aligner systems.
A popular example of this technology in action is the Invisalign aligners. They are an alternative to braces. And they are an option in approximately 80% of the orthodontic cases. From mild to complex.
Continued improvements into Invisalign technology enable it to correct more complex malocclusions. This makes it one of the most advanced clear aligner system in the world (Align data on file).
Due to the complexity of these systems, it is vital that they receive proper regulation.
Align Technology’s Invisalign clear aligner systems and Vivera retainers were recently certified by the European Union as Class ll-a medical devices.
The process to obtain the Class II-a EC certification is extensive. It requires an in-depth review, based on evidence compiled and reviewed by DEKRA Certification BV. This is an independent external EU notified body and certification body for medical devices.
Following this important milestone, Align Technology is the first company to achieve this certification for its clear aligners.
This means they are independently recognised as safe and effective medical devices. To the same extent as traditional brackets and wires.
Reinforcing safety and efficacy
From a clinical perspective, Invisalign clear aligners are not only more comfortable than braces (White et al, 2017), but also treatment with Invisalign is often completed sooner on average than treatment with braces (.
Doctors can also use the Invisalign clear aligner systems with attachments. As well as other special features to effectively treat certain types of malocclusions.
The fact that the Invisalign clear aligner systems are Class II-a certified medical devices offers further reassurance to dentists and orthodontists. It also reinforces the need for a trained and qualified clinician to oversee clear aligner treatments. This will potentially prevent serious dental problems that could occur due to misuse of the device.
This certification reflects Align Technology’s commitment to providing high quality solutions to healthcare professionals.
The company has also successfully re-registered all other products according to the requirements and risk classification rules of the new regulations (EU) 2017/745, that became effective on 26 May 2021.
Medical devices have become more sophisticated as a result of technological advancements. And the regulatory framework has adapted to reflect this.
It is critical to guarantee that these medical devices are properly regulated, with sufficient information available to support informed consent and broad acknowledgement of the important role of dental professionals to protect patients.
White D, Julien K, Jacob H, Campbell P and Buschang P (2017) Discomfort associated with Invisalign and traditional brackets: A randomized, prospective trial. The Angle Orthodontist 87(6): 801-8