The new Medical Devices Regulation: improving safety through expert auditing
Healthcare professionals use medical devices to improve and save patients’ lives every day, from endoscopes and pacemakers to contact lenses. They are designed and manufactured to help people, but faulty or low-quality devices can be harmful.
New EU legislation, the Medical Devices Regulation (MDR), sets out more stringent requirements for medical devices, improving their safety and transparency. Kiwa Cermet Italia has been designated a notified body for the MDR. In this article, we look at the MDR, what it means for manufacturers and other companies, and how Kiwa will be working with it as a notified body.
The MDR: more stringent rules for safer devices
Medical devices have long been subject to regulation in the EU. The Medical Devices Directive (MDD) had been in effect since 1993. A lot changed in the subsequent 20 years, in terms of innovation and technology, including the introduction of substance-based and 3D-printed medical devices. There were also some high-profile scandals that caused widespread attention to medical device legislation. In 2010, for example, a French breast implant manufacturer was found to be using industrial-grade rather than medical-grade silicon, with tragic results.
In 2012, the European Commission decided to update the laws, to take into account these new developments. The aim was to ensure a robust, transparent and sustainable new regulatory framework that would maintain a high level of safety, while supporting innovation. After five years of development, the new Medical Device Regulation (MDR) was published in May 2017. It became applicable four years later, on 26 May 2021.
The MDR will have a big impact on manufacturers as well as many other new players in the medical field, such as importers, distributers and EU representatives. Alessia Frabetti, Medical Devices Division Director at Kiwa Italia, commented: “The MDR will completely change the medical sector. It will bring great benefit, but also great challenges for all the economic operators involved.”
The requirements the MDR defines are much more stringent, putting the medical device sector closer to the pharmaceutical market. Manufacturers will need to strengthen their controls and transparency, and this will require investment. Alessia predicts that some companies should decide to leave the market because they will not be able to invest enough to be compliant. On the other hand, this will provide opportunities for large medical device manufacturers to buy smaller companies and drive innovation, she says.
One big change will also open the door for esthetic device manufacturers to enter the market. The MDD did not cover devices used for esthetic purposes, but these are now included in the MDR. For example, previously, contact lenses that improve vision were considered medical devices in the MDD, but those used to change eye color were not. Similarly, lasers used for medical procedures were covered, but those used for hair removal were not. In the MDR, devices like these used by estheticians are now included as medical devices, and therefore subject to the regulation.
“Everything is changing compared to previous requirements,” Alessia said. “One of the crucial points is to be ready for the change – to accept that we have to change not only the assets, but the way we think."
MDR definition medical device
The MDR defines ‘medical device’ as “any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings” for a number of specific medical purposes, including the “diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.”
To read the full definition, see Article 2, clause 1 of the MDR.
Kiwa Italia is a MDR notified body
Kiwa has been authorized to certify manufacturers against the MDD for many years. As of 14 July 2021, Kiwa Cermet Italia is a designated notified body for the MDR. The MDR designation process was long and intense, designed to ensure Kiwa is able to carry out the work required to a high standard.
All the phases of designation process required a huge involvement of the whole medical staff. Alessia says: "We've worked very hard to achieve the objective. Despite the difficulties and the Covid-19 pandemic impact that delayed the designation process globally, thanks to our great medical team and our Kiwa management, we were able to achieve our goal. We were also able to further improve our competences, that will be useful for future services."
In July, Kiwa Italia became the 21st notified body for the MDR. There are currently 22 notified bodies, and while some more will be designated in the coming months, the EC has drastically reduced their number compared to the 89 that existed in 2016. Given the shortage of qualified, experienced people able to work as assessors, this provides Kiwa and the other notified bodies with a major challenge: a greater workload, but not enough people to deliver.
There is a lot of competition for suitable expertise in the field, and when you do find someone with the right skills and technical expertise, it takes a year for them to become a qualified auditor. “It’s crucial for us to have a very good human resources policy that is attractive for people and involves them,” Alessia said. “Auditors have a lot of responsibility and pressure, yet they often carry out activities alone. At Kiwa, we want to make sure they don’t feel alone, but appreciated as part of a greater organization – a family.”
Alessia Frabetti, Medical Devices Division Director at Kiwa Italy.
Medical Devices Business Sector Leader
Alessia has a bachelor’s degree in biology, with a specialization in biohealth and microbiology, and a PhD in architectural technology relevant to the management of healthcare structure and clean rooms. Alessia’s experience in the hospital setting and working on applied research began at university. Since 2002, she has worked with hospitals, pharmaceutical companies and medical device companies on issues like product development and production, supplier qualification, and validation of sanitization and of medical environments.
When Alessia first gained experience with Good Manufacturing Practice (GMP) authorization and the role of quality management system certification, she saw the importance of auditors in the process. In 2007, she began working with major certification companies, and in 2014, she joined Kiwa.
Her role has moved from being focused on technical aspects to more business development work; since January 2021, Alessia has started her role as Medical Devices Business Sector Leader for Kiwa Group. “It's very exciting for me,” she said. “I challenged myself to improve and go deeper on the international business development of the medical sector, and the relationship with my colleagues in other countries.”
Alessia’s time is equally split between her Kiwa Cermet Italia role as Director of the Medical Devices Unit and the new role. And she still spends about 15 percent of her time on technical activities – auditing, assessing and reviewing. “Maintaining qualifications and expertise is crucial for our work in this area and also because only through the competence of senior internal employees was Kiwa able to receive the MDR designation as well as to maintain it for the future.”
To find out more about Kiwa’s work in the medical devices sector, visit our global website.