In this article we explain how the transition from Directive 93/42 to the Medical Devices Regulation takes place and the new aspects that this regulation presents for manufacturers of medical-grade refrigerators.
The MDR, better known by its acronym Medical Devices Regulation, will be a step forward in the quality standards of all devices for medical use that will be manufactured in Europe.
At Coreco we are already working on it. When the new regulation comes into force, our products are adapted to the requirements of the MDR and available for immediate marketing.
Transition from Directive 93/42 to the Medical Devices Regulation (MDR)
The European Parliament has approved the new Medical Devices Regulation (MDR). Manufacturers of medical devices must 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 Devices Regulation (MDR) was published on 5th May 2017 and entered into force on 25th May 2017. For manufacturers of medical devices already approved there is a transition period of three years, that is until 26th May 2020 (postponed to 26th May 2021), to meet the requirements of the regulation.
For some manufacturers, the TDM provides for an extension of the transitional period. In this case, the products may continue to be marketed up to a maximum of four years after entry into force. Additional requirements apply to the extension of the transition period.
The most important changes to the TDM
The MDR seriously differs from the current EU Directives on medical devices. Among the most important changes are:
-Extension of the scope
The definitions in the field of medical devices will be considerably extended to include, for example, non-medical products, such as colour contact lenses, as well as implants and substances for aesthetic purposes.
Experts hope that the devices for predicting and forecasting disease risk also fall within the scope of the regulation.
– Appointment of a qualified person
Manufacturers of medical devices should designate at least one person within their organisation. This person will be ultimately responsible for ensuring compliance with the requirements of the new Medical Devices Regulation.
The organisation must demonstrate the specific qualifications with respect to the tasks required. So-called small and micro-enterprises may be subject to minor requirements.
– Implementation of the single product number system
The proposed Medical Devices Regulation requires a Single Product Identification System (UDI). This requirement is intended to make it easier for manufacturers and authorities to trace certain products within the supply chain, thus allowing for the rapid and effective removal of medical devices that pose a safety risk.
It also aims to increase the size of the European Medical Devices Database (EUDAMED) by facilitating access to information on approved medical devices (note: the launch of EUDAMED has been postponed until May 2022).
– Strict clinical surveillance after marketing.
The new Medical Devices Regulation extends the powers of notified bodies in the field of post-market clinical surveillance.
Unannounced audits, random sampling and product testing reinforce the EU implementation process and help reduce the risk posed by unsafe medical devices. For the groups of devices defined, manufacturers must submit annual reports on the safety and performance of their devices.
– Specifications
The MDR aims to introduce the regulatory instrument of the «common specifications». It will enable the EU Commission or groups of experts to publish common specifications which will apply to both manufacturers and notified bodies. These will apply in parallel to any existing harmonised standard.
– Classification of products according to risk, duration of contact and invasiveness
According to the new RDM, manufacturers should 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 more stringent clinical requirements. These medical devices are therefore subject to a mechanism for monitoring conformity assessments (scrutiny process).
– Strict statistics 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 should collect and store clinical data for the continuous assessment of potential safety risks
– Systematic clinical evaluation of Class IIa and IIb medical devices.
Manufacturers must renovate their clinical evaluation. To this end, account should be taken of the redrafting of the regulation on the equivalence of products and of the circumstances in which a clinical evaluation may legitimately be omitted.
– No acquired rights
According to the MDR, all currently approved medical devices must be re-tested and certified according to the new requirements.
Experience Coreco
We hope that this small article has provided you with some information of interest.
Please, if you have technical questions about the regulations or about the products, do not hesitate to contact us through info@coreco.es
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Manufacture of medical refrigerators according to ISO 13485