European Union: What Does The New European Union Medical Device Regulation Bring?

I. INTRODUCTION

The Medical Device Directive ("MDD") of the European Council numbered 93/42/EEC, which came into force in 1993 and amended in 2007 with the Directive 2007/47 /EC, was the primary regulation in the field of medical devices in the European Union ("EU") for many years and has served to harmonize the legislation on medical devices among EU countries. However, with developing technology and changing needs, MDD has become an outdated regulation that needs to change. To fulfil this need, the Medical Device Regulation of the European Council numbered EU 2017/745 ("MDR") was published on May 5, 2017, and entered into force on May 25, 2017. A three-year transition period is foreseen for the full implementation of MDR and the date of May 26, 2020, was determined as the last day of these three years. However, in April, the implementation of MDR was delayed for one year due to the COVID-19 pandemic, which affected Europe severely, and the new deadline was set as 26 May 2021.¹ In this article, we will explain some important changes brought by MDR, which carries great importance for Turkey as well.

II. IMPORTANT CHANGES INTRODUCED WITH THE NEW MEDICAL DEVICE REGULATION

It is possible to gather some important issues in MDR, which aims to keep up with the rapid change of the medical device industry and to increase the reliability of the medical devices, under a few sections.

One of the important changes brought by MDR is to an expansion of products and devices covered by the legislation. In this context, devices designed for the prediction and prognosis of the disease, implants and reagents, devices to support pregnancy and disinfection or sterilization of medical devices and accessories for medical devices have been added to the definition of the medical device. Also, the devices used for investigation, replacement or modification of the anatomy or a physiological or pathological process or state are included in the definition of "medical device". Besides, contact lenses and silicone implants used for cosmetic purposes were added to the products included in Annex 16 of MDR, where the devices that must comply with MDR are listed. Another noticeable change is that the software is now included in the MDR's scope.

Unique Device Identification ("UDI") System will be created to identify and facilitate the traceability of medical devices except custom-made and research-purposed devices, and the manufacturers are obliged to assign a UDI ID to the devices they produce and record this on the system. Also, manufacturers are obliged to assign the UDI they have set for their devices to the device and, if applicable, to the device's packaging, before placing a device on the market. except for the custom-made devices.

Besides, manufacturers are obliged to provide the patient with an implant card for all implantable medical devices. The information that should be included in these implant cards is defined in the 18th article of MDR titled "Implant Card And Information To Be Supplied To The Patient With An Implanted Device" These are;

• Information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer
• Any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions
• Any information about the expected lifetime of the device and any necessary follow-up,
• Any other information to ensure the safe use of the device by the patient.

According to the Article 2 of MDR titled "Definitions" post-market surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions. One of the new regulations introduced with MDR related to vigilance and post-market surveillance is described in article 33 of MDR. Accordingly, the European Database on Medical Devices ("EUDAMED") will be established and within EUDAMED, devices accredited Notified Bodies, Certificates, Serious Incidents, Safety And Clinical Performance Reports, Periodic Safety Update Reports, Surveillance Activities, Clinical Research Data, UDI identities and Single Registration Numbers, and information from the manufacturer, authorized representative and importer will be associated. Device manufacturers are required to report Safety and Clinical Performance annually. Besides with MDR, inspections can be made without prior notice and product sample checks can be performed. ²

According to the 15th article of MDR titled "Person Responsible For Regulatory Compliance", manufacturers are obliged to have at least one person available within their organisation for regulatory compliance who possesses the requisite expertise in the field of medical devices. This person is obliged to ensure that the devices are checked for compliance with the quality management system in which they are produced, the technical documentation and the EU declaration of conformity are kept up-to-date, and the reporting and declaration obligations within the scope of MDR are fulfilled before a device is placed on the market. This person must be proven by providing the necessary training and professional experience conditions that he has the necessary expertise and competence. Although micro and small businesses do not have to have the person responsible for the compliance, within their organization, they are required to receive regular service from a person who will provide this service. This person is obliged to ensure the conformity of the devices with the quality management system under which the devices are manufactured before a device is released, that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date, to comply with the post-market surveillance obligations and the reporting obligations in the MDR. This person must prove their expertise by satisfying the necessary training and professional experience conditions. Micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organisation however, they are obliged to receive services from such a person permanently and continuously.

III. CONCLUSION

Although full compliance within the EU has been delayed due to COVID-19, it is possible to say that MDR has already brought significant changes. Medical device legislation in Turkey is in line with EU legislation and MDR is not expected to be an exception to this compatibility. In order to ensure compliance with MDR, Turkey's own Medical Device Regulation ("Regulation") has been prepared and it is expected to be published and enter into force in the near future. With the enforcement of the Regulation, there will be an opportunity to observe what changes will occur in the field of medical devices in practice.

Footnotes

1. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52020PC0144

2. https://www.meddeviceonline.com/doc/key-changes-to-understand-in-the-new-european-mdr-and-ivdr-0001