Directive 93/42 and the Medical Devices Regulation

In this article, we explain how the transition from Directive 93/42 to the Medical Devices Regulation is taking place and the new challenges this regulation presents for manufacturers of medical-grade refrigerators.

The MDR, better known by its English acronym, the Medical Devices Regulation, will represent a step forward in the quality standards for all medical devices manufactured in Europe.

At Coreco, we are already working to ensure that, when the new regulation takes effect, our products will comply with the requirements of the MDR and be available for immediate sale.

Transition from Directive 93/42 to the Medical Device Regulation (MDR)

The European Parliament has approved the new Medical Device Regulation (MDR). Medical device manufacturers should expect major changes in the near future.

The new EU Medical Devices Regulation replaces the current Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC).

Transition Period

The European Medical Device Regulation (MDR) was published on May 5, 2017, and entered into force on May 25 of that same year. For manufacturers of already approved medical devices, there is a three-year transition period—that is, until May 26, 2020 (extended to May 26, 2021)—to comply with the regulation’s requirements.

For some manufacturers, the MDR provides for an extension of the transition period. In this case, products may continue to be placed on the market for up to four years after the regulation takes effect. Additional requirements apply to the extension of the transition period.

The Most Important Changes in the MDR

The MDR differs significantly from the current EU Directives on medical devices. Among the most important changes are:

-Expansion of the scope of application

The definitions in the field of medical devices will be significantly expanded to include, for example, products not intended for medical use, such as colored contact lenses, as well as implants and substances used for cosmetic purposes.

Experts expect that devices designed to predict and forecast the risk of disease will also fall within the scope of the regulation.

-Appointment of a qualified person

Medical device manufacturers must designate at least one person within their organization who will be ultimately responsible for ensuring compliance with the requirements of the new Medical Device Regulation.

The organization must demonstrate this person's specific qualifications with respect to the required tasks. So-called small businesses and microenterprises may be subject to less stringent requirements.

-Implementation of the unique product number system

The proposed Medical Device Regulation requires a Unique Device Identification (UDI) system. This requirement is intended to make it easier for manufacturers and authorities to trace certain products throughout the supply chain, thereby enabling the rapid and effective recall of medical devices that pose a safety risk.

It also aims to expand the European Database on Medical Devices (EUDAMED), facilitating access to information on approved medical devices (note: the launch of EUDAMED has been postponed until May 2022).

-Strict post-marketing clinical monitoring.

The new Medical Device Regulation expands the responsibilities of notified bodies with regard to post-market clinical surveillance.

Unannounced audits, random sampling, and product testing strengthen the EU enforcement process and help reduce the risk posed by unsafe medical devices. For defined device groups, manufacturers must submit annual reports on the safety and performance of their devices.

-Specifications

The MDR aims to introduce the regulatory instrument of «common specifications,» which will allow the European Commission or expert groups to publish common specifications that will apply to both manufacturers and notified bodies. These specifications will apply alongside any existing harmonized standards.

-Classification of products based on risk, duration of contact, and invasiveness

Under the new MDR, manufacturers must review the new classification rules and update their technical documentation accordingly. It should be noted that Class III medical devices and implantable devices are subject to stricter clinical requirements. Therefore, these medical devices are subject to a conformity assessment control mechanism (scrutiny process).

-Strict statistical requirements for Class III medical devices and implantable devices

Manufacturers that do not have sufficient clinical evidence to demonstrate the required safety and performance of a given product are required to conduct clinical investigations. In addition, manufacturers must collect and retain clinical data for the ongoing assessment of potential safety risks.

-Systematic clinical evaluation of Class IIa and IIb medical devices.

Manufacturers must redo their clinical evaluation. To do so, they must take into account the new wording of the regulation on product equivalence, as well as the circumstances under which a clinical evaluation may legitimately be omitted.