Introduction
With more than 760.000 people directly employed, the medical device industry accounts for around 0.3% of total employment in Europe, while the value added per employee is estimated to reach 184,000 euros per employee (1).
The medical technology industry is indeed crucial for Europe’s economy and even more for patients’ health in Europe and the World, as the above indicators clarify.
Medical devices impact the lives of millions of people.
We can divide the medical technologies into three main categories:
1. Medical devices (MDs): are products, services or solutions that prevent, diagnose, monitor, treat and care for human beings by physical means.
2. In vitro diagnostics medical devices (IVDs) are non-invasive tests used on biological samples (for example blood, urine, or tissues) to determine the status of a person’s health.
3. Digital health refers to tools and services that use information and communication technologies (ICTs) to improve prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
The change from an EU Directive (MDD) to an EU Regulation (MDR) was at a certain point the required step to protect patients and ensure that only safe and effective medical devices are available on the market.
On May 5, 2017, the European Commission published a new Regulation for medical devices, which will replace the existing Directives. This article provides an overview of the new Regulation and how it will impact medical device manufacturers.
Why there was a change from an EU Directive to an EU Regulation
There are several reasons why the European Union (EU) is changing its medical device Regulation. One reason is that the current legislation is more than 20 years old and needs to be updated to reflect advances in technology. Since the 1990s technology has advanced, we now have medical apps and 3D printing. This new technology will be covered by the EU Regulation.
Another reason is that the EU wants to align its Regulations with those of other major economies, such as the United States. Finally, the EU wants to make sure that its citizens have access to safe and effective medical devices.
The new Regulation will place greater emphasis on safety and will require manufacturers to provide more data about their products.
Under the new MD Regulation, some changes have been introduced in the risk-based classification system. Classification of medical devices drives many pre- and post-market requirements. Due to the large variety of products, the level of control made by a third party (the “notified body”) before placing them on the market depends on the level of impact on the human body that their use might imply. The same notified body is involved post-market to ensure the continued safety and performance of medical devices.
“Class III” devices are a new category of medical devices which will be subject to the highest level of scrutiny. The class of each de-
vice is linked to the potential risk posed to the health of the public and an individual because of a failure in functioning. All MDs are classified under class I, IIA, IIB or III, with class III being the highest risk class.
The changes will apply to all medical devices sold in the EU.
Structure of the Medical Device Regulation 2017/745
The Medical Device Regulation 2017/745 consists of (2):
- 101 Preamble’s
- 123 Articles in 10 Chapters
- 17 Annexes
- 175 pages
The MDR is divided into chapters: chapter 3 is dedicated to the identification and traceability of devices, registration of devices and of economic operators, a summary of safety and clinical performance, and the European database on medical devices (EUDAMED).
The purposes of EUDAMED are among all to enable the unique identification of devices within the internal market and to facilitate their traceability, the final aim is to inform the public about devices placed on the market and the corresponding clinical investigations carried about to guarantee their safety.
EUDAMED is one of the innovations introduced by the EU MDR 2017/745, where a new term also appears: “Economic operator” and it is defined as “a manufacturer, an authorized representative, an importer, a distributor or a person” that is part of the product supply chain. This includes, for example, manufacturers, importers, distributors, and warehousing facilities.
In the medical device Regulation, there are 8 annexes: the second and third of them introduce the technical documentation and the technical documentation on post-market surveillance.
The technical documentation to prove safety and efficacy is new to Medical Device Regulation.
There are now 22 rules in the MDR compared to the 18 rules in the MDD.
Main changes introduced by the new Regulation
The main changes introduced by the Regulation are:
– A new classification system for medical devices, based on the risks they pose to patients and users;
– New clinical evaluation requirements for all medical devices;
– More stringent post-market surveillance requirements;
– Tighter rules on device manufacturers, importers, and distributors;
– New requirements for notified bodies;
– Strengthened powers for the European Commission and national authorities.
The Medical Device Regulation will bring three major changes:
- Harmonization
- Transparency
- Traceability
Medical Device Regulation 2017/745 EU timelines
It was adopted on the 5th of April 2017 and published in the Official Journal of the European Union on the 5th of May 2017. The Regulation came into force on the 25th of May 2017.
This is the norm, once is published in the Official Journal of the European Union and it comes into force 20 days later.
MDR was to come mandatory on the 25th of May 2020 but on the 23rd of April 2020 the European Commission pushed out the date of the MDR 2017/745 to the 26th of May 2021 due to the Covid pandemic. The application date was postponed by 1 year.
From the 26th of May 2021 on, no medical device can be certified under the old Directives anymore.
The timelines for the transition of the MDR 2017/745
The Medical Devices Directive (93/42/EEC) was introduced in 1993 and was last amended in 2007. The Directive provides a regulatory framework for the marketing of medical devices in the European Union (EU).
As cleared above, the Directive is currently being replaced by the Regulation on Medical Devices (EU) 2017/745, which was published in the Official Journal of the EU on 5 May 2017. The Regulation will come into force on 26 May 2020 and will apply from 26 May 2021.
From that date, all medical devices placed on the market must comply with the provisions of the MDR.
The transition period from the old Directive to the new Regulation will last three years.
From May 2024, all devices placed on the market must be compliant with the MDR.
Transition is explained in article 120 of the MDR 2017/745
Conclusion
As we can see, the Regulation of medical devices is a complex and ever-evolving process. To ensure the safety and efficacy of these products, it is essential that manufacturers work closely with regulatory authorities to ensure compliance. The implementation of the new EU Medical Device Regulation will no doubt bring about some challenges, but by working together we can overcome them and continue to provide safe and effective medical devices to patients across Europe.
References:
(1) https://www.medtecheurope.org/wp-content/uploads/2021/06/medtech-europe-facts-and-figures-2021.pdf
(2) https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745