Introduction to Medical Device Regulations - MDR
For 30 years medical devices have been governed by the Medical Device Directive (MDD) implemented in EU/EEA in 1993, and there have been quite a few developments in the field of medical devices since then. For instance, apps used as stand-alone products for different medical purposes have become a reality. The general population has become older, patients are more used to finding medical information on the internet, and the beauty industry uses more advanced and invasive techniques than before. These changes, and more, have prompted an update of the control of medical devices for some time. Eventually, the new Medical Device Regulations (MDR) were developed and came into force on May 26, 2021. From this date, all new medical devices and the manufacturer’s quality management system must comply with the MDR. Implementation deadlines for existing devices are dependent on classification and expiry of existing MDD certificates.
The MDR mainly regulates the manufacturers, notified bodies*, authorized representatives**, importers and distributors. Most of these organizations were aware of the changes and worked with the MDR preparations for several years. New staff has been employed, quality management system updates have been implemented, and the technical documentation has been adapted to the new requirements.
The MDR does not directly control health care providers. Nevertheless, some health care providers have shown interest in the MDR and expressed concerns regarding compliance and availability of medical devices. This concern may be well-founded since, in some cases, due to increased costs and complexity of registrations related to the MDR, several devices are expected to be removed from the market in the coming years.
This blog post will highlight some areas of the MDR and explain why Vitrolife is in a good position to maintain regulatory approvals in EU/EAA and provide products without disruptions.
Already in 2002 the Medical Device Expert Group pointed out some weaknesses in the MDD and that report resulted in an amendment to the MDD in 2007.
In 2010 there were a couple of medical device scandals: the PIP breast implant and MOM hip implant scandals:
- The PIP breast implant scandal was caused by the manufacturer who used industrial-grade silicon to save money. This resulted in high implant rupture rates, and 30.000 women were recommended to have the implants removed in France alone.
- The MOM hip implant scandal also had severe consequences for thousands of patients.
These two scandals sparked an increased pressure on the EU Commission to improve the control of medical devices and address the changes mentioned above. The Commission initiated a work which eventually resulted in the MDR.
The MDR implementation schedule was and is as follows:
- 2017-05-26: The MDR entered into force with a transitional period of three years.
- 2020-05-26: According to the MDR, all new products must be registered, but it was postponed one year due to the COVID-19 pandemic.
- 2021-05-26: All new products and existing class I devices must be registered according to the MDR. No more approvals according to the MDD, but current MDD CE certificates are still valid until their expiry date which is no later than 2024-05-26. Devices approved under the MDD certificates may be placed on the market until the expiry date of the MDD CE certificate.
- 2024-05-26: Last expiry date of MDD CE certificates and last date to place MDD devices on the market. The one-year sell-off period starts.
- 2025-05-26: The last date to sell devices under a MDD CE certificate.
The above means devices will still be distributed to clinics that conform to the MDD for another four years from now.
The MDR updates
The MDR describes how to obtain both the CE certification and the subsequent control during the entire life cycle of the device, while the MDD only described how to get the CE certificate. Hence, the MDR includes a life cycle approach which was lacking in the MDD. Examples of the life cycle approach are the increased focus on post market surveillance requiring periodic safety reports, continuous clinical follow up and improved trend reporting.
There is also more emphasis on clinical evidence of safety and performance. Class III devices (e.g. IVF media) require clinical investigations to show safety and performance, while lower classes require extensive clinical evaluations.
Another area of improvement is market transparency and traceability. All devices will have a unique identification, improving traceability and control of the devices, for instance, during recalls. Manufacturers, notified bodies, authorized representatives and the approved devices must be entered into a new database called Eudamed (not yet fully functional). Information on clinical studies, periodic safety reports and adverse event reporting will be available in Eudamed to authorities and to some extent, the public.
New types of products are classified as medical devices in the MDR, such as equipment used for cleaning and sterilization of medical devices and products used for control of conception. Also, products with no medical purpose are also included. Examples are equipment for removing tattoos, colored lenses, equipment for liposuction and substances used for facial filling. Additionally, the MDR introduces stricter rules for classification of software products.
Moreover, the MDR mandates that the manufacturer assigns one or several persons as Person Responsible for Regulatory Compliance. This is similar to the Qualified Person required in pharmaceutical companies.
Finally, persons fascinated by statistics can be interested in the numerical comparison between the MDD and MDR in Table 1.
Number of general requirements
Number of pages
Number of articles
Number of annexes
Table 1. Numerical comparison between MDD and MDR.
Consequences for the medical device industry
The new MDR has increased the requirements for the notified bodies, authorized representatives, manufacturers, importers and distributors. The requirements are significantly affecting the amount and detail of documentation that the manufacturer needs to show compliance to. As a consequence, several manufacturers will remove devices from the market once the MDD CE certificates expire since the cost and effort to show compliance to the MDR are too high.
The requirements for notified bodies have increased as well. Less than half of the original notified bodies have decided to not get accreditation according to the MDR. Also, some of the notified bodies that are getting accreditation are reducing their scope and dropping product categories/codes. Approximately 50 notified bodies were accredited according to the MDD, but currently only 22 notified bodies are accredited to the MDR. This mean that less than half of the original notified bodies are expected to not only handle the increased requirements of the MDR, but they will also have to handle the customers migrating from the other 28 notified bodies that are not getting accreditation. However, notified bodies are not required to accept new customers, so manufacturers may be left in the cold without a notified body. Also, manufacturers may experience some delays due to the increased workload for the notified bodies.
Vitrolife and the MDR
Vitrolife has registered medical devices worldwide for two decades and compiled complete technical documentation for the devices. With regulatory experience from major markets such as Australia, Canada, China, EU, Japan and the USA, Vitrolife is well prepared for the MDR registrations. Additional documentation has been prepared specifically for the MDR and labelling has been updated to comply with some new requirements. For IVF media, for example, a symbol indicating that it is a medical device, a symbol indicating that the device contains a medicinal substance, and a symbol indicating if the device contains a blood derivative. However, the actual medical devices are not being changed at all, only documentation and labelling.
It is essential that the notified bodies are accredited according to the relevant MDR product categories. Vitrolife is working with four different notified bodies. All of them have been accredited to the correct ART product categories (codes) which means that they are allowed to issue MDR CE certificates for all Vitrolife products once the review process is completed. The MDR preparations and collaboration between Vitrolife and its notified bodies have been ongoing for a long time, and the first CE certificate has already been issued. The rest of the devices are scheduled to obtain their MDR CE certificates) well before the current MDD CE certificates expires in May 2024.
The implementation of the MDR has increased the regulatory burden for both medical device manufacturers and notified bodies in the EU/EAA. Vitrolife and Vitrolife’s notified bodies are well-prepared to re-certify the existing devices according to the MDR. The MDR implementation is not expected to cause any disruptions to deliveries within EU/EAA.
**authorized representative – an authorized representative in EU is a legal entity designated by a manufacturer located outside EU to represent them in EU.
Learn more about how Vitrolife works with quality control.
Written by Hans Lehmann
As responsible manager for media development, regulatory affairs and post market, Hans has experience of the products and product labelling from the very initial development phase to the end of the product life cycle. Hans has been with Vitrolife for 20 years and has been involved numerous projects such as development of new products, global registrations, quality improvements and introduction of the environmental management system.