Q&A: The process of obtaining CE mark

Erik Raadsheer, PhD, sr. director, regulatory & government affairs and quality assurance, EMEA, Align Technology, explains the processes of obtaining the CE mark for its Invisalign clear aligner system and Vivera retainers.

First of all, tell us about the Invisalign aligners?

Invisalign aligners are a clear aligner system designed to transform smiles, providing a more modern and aesthetically pleasing alternative to the traditional wire and bracket method for tooth movement. 

The Invisalign clear aligner system is manufactured by Align Technology, a medical device manufacturing company that has been dedicated to innovating orthodontic technology for the past two decades. We have worked to continuously evolve the Invisalign system over the years with the latest technology to ultimately improve smiles and change lives.

Invisalign aligners are trimmed based on each patient’s gum line to provide greater patient comfort. And combined with their virtually invisible look, they provide optimal aesthetics too. Invisalign aligners and retainers are made of medical-grade, high molecular weight, thermoplastic polymer. This patented material called SmartTrack was created exclusively for Align Technology after years of research, to provide more comfort, a better fit, and superior biomechanical characteristics. It is also clinically proven to improve tooth movement.

The Invisalign aligners were designed to correct more complex malocclusions – including Class 2, open bite, bicuspid extraction, and deep bite. This makes Invisalign currently the most advanced clear aligner system in the world, and we are proud to have helped doctors treat over 11 million patients worldwide.

The aligners have been CE marked. Can you explain the work you had to do obtain it?

The process to obtain the Class II-a EC certificate was quite extensive and required an in-depth review of the product’s technical files, including clinical evaluation and risk management files. In addition, a thorough quality audit of the company’s production processes was also conducted. DEKRA Certification B.V., one of the world’s largest independent external EU notified body and certification body for medical devices, were responsible for inspecting our devices. 

As a company which values doctor-led therapy and patient safety, it was crucial for Align Technology that our Invisalign aligners and Vivera retainers met the essential requirements as set out in the applicable regulations in the EU. At Align, we recognise the importance of creating well-regulated appliances to assure healthcare professionals that their patients are being treated with safe and clinically effective devices. The certification we received signifies that the product design of the Invisalign system and Vivera retainer meet the general safety and performance requirements of council directives 93/42/EEC and 2007/47/EC.

Can you explain the different kinds of paperwork you had to provide under the EU regulation?

We compiled a series of technical files consisting of data collected over many years, including clinical evaluation reports, risk management files, and biocompatibility data. These files were then submitted to DEKRA, who conducted a detailed review and completed a thorough quality audit of the company’s production processes. 

What lessons do you think you’ve learnt going through this particular regulatory process?

We soon learned that the journey to obtain the Class II-a EC certification would be quite extensive and not without challenges – from start to finish, the whole process took several years. Despite this, the time it took to complete the process also reassured us that our aligners were being reviewed against the most stringent of standards. It also showed us that regulatory bodies, such as DEKRA, are incredibly thorough and attentive in their review processes, which is critical in ensuring that devices are well regulated.

We also witnessed how regulatory frameworks are continuously evolving and adapting. This is crucial as, over the past decade especially, we have certainly seen significant advancements in medical technology. In the dental field in particular, such advancements are transforming orthodontic practices to deliver more accurate tooth movement and a more comfortable patient experience.

Anything else that you’d like to add? 

Align Technology’s commitment to obtaining this certification reflects our goal to provide high-quality orthodontic solutions to healthcare professionals and patients alike. Moreover, by establishing that our aligners are indeed medical devices, it reinforces our stance in placing experienced and skilled orthodontists at the centre of orthodontic treatment to create an enriched and customised patient experience.

The Invisalign clear aligner system and Vivera retainers made Align Technology the first aligner company to achieve this class II-a EC certificate for its clear aligners. These devices have been independently recognised as safe and effective medical devices to the same extent as traditional brackets and wires.