Everything comes to an end … even the reprieve granted due to a pandemic.
In terms of medical device legislation, we are in a transition period until 26 May, when the previously applicable Medical Device Directive (MDD) will be replaced by the new Medical Device Regulation (MDR) published in 2017. But why is this amended form of the act important?
The main point is that the new regulation is much more binding. In a directive, the EU only sets one target, which leaves a lot of room for manoeuvre to the individual countries in terms of implementation. However, the newly adopted regulation is a binding legal act that all countries must comply with in the same way. As a result, the provisions are much more uniformly regulated, avoiding discrepancies in interpretation far more effectively.
What exactly is changing?
Most of the MDD requirements remain in the new MDR and have been additionally supplemented by new ones. Medical software is becoming more of a focus and many software products now have to meet stricter requirements as they have been assigned higher than Class I.
New classification of products
Medical devices are classified into ascending risk classes and with the new MDR new risk classification rules apply, which have been extended from the previous 18 (MDD) to 22 (MDR). The risk of medical devices is based on the vulnerability of the human body to the device, which in turn is directly related to the site and duration of use. The more invasive the product and the longer the period of use, the higher its risk class and more complex the required conformity assessment procedure is to launch the product on the market. In the EU, medical devices are divided into four main classes I, IIa, IIb and III:
Low risk and non-invasive like reading glasses, wheelchairs or bandages. There are three subclasses: Im (products with a measuring function) such as stethoscopes, scales and thermometers, Is (products that enter the market sterile) for example protective equipment and new in the MDR Ir (products that are reused or reconditioned) such as surgical instruments.
Medium risk, invasive or non-invasive, short term use such as disposable syringes, hearing aids, ultrasound diagnostic devices.
Increased risk, implantable and/or invasive for long-term use such as ventilators, infusion pumps, defibrillators.
High risk, implantable and/or highly invasive for long term use such as artificial joints, breast, dental and other implants.
MDR places higher requirements on notified bodies
The conformity assessment procedure also varies according to the class. This is used to check whether the medical device complies with the European directives: Is it safe to use? Does it perform as it claims to? Since this must be evaluated and substantiated by clinical studies, the new MDR has also significantly increased the requirements for the testing bodies, especially with regard to clinical competence.
For Class I devices, which do not belong to the above-mentioned subclasses, it is left to the manufacturers to ensure this through their own quality management system. For the other classes, the product must be approved by one of the “Notified Bodies”, a government-supervised testing body. This also applies to the three Class I subclasses: Im, Is and Ir.
The new aspects: UDI and EUDAMED
The MDR introduces another new aspect, a system for unique product identification called UDI (Unique Device Identification). The aim is to use this number to improve the identification and traceability of medical products. For example, a product that has been found to pose a safety risk can be recalled quicker.
All UDI related data must be entered by manufacturers into the new European Database for Medical Devices (EUDAMED). This contains the UDI database. Manufacturers are obliged to keep the information on EUDAMED up to date. The deadline by which individual products must have a UDI depends on their classification – the higher the risk class, the earlier: Class III and implantable devices by 26 May 2021; Class IIa and IIb until 26 May 2023; and Class I by 26 May 2025.
What does the new MDR mean for technical documentation?
Technical documentation is the basis for CE marking and conformity assessment and must be kept up to date throughout a product’s life cycle. When you consider that a product’s life cycle from development and testing to regulatory approval, product launch, marketing, and post-market surveillance, consists of countless phases that are closely linked to the new MDR classifications and requirements, creating MDR-compliant documentation becomes a mammoth task. And this does not only mean volume, because especially in the phases regarding regulatory approval, the IFUs, product labels, UDI and the like usually have to be available in other languages as well.
What are we waiting for?
The reprieve is coming to an end. Anyone who has so far assumed that the entry into force of the complete MDR will now be delayed by one year is mistaken. Strictly speaking, the period of entry into force with all its details is only being shortened by one year – and that’s at the beginning. Consequently, all those who would already have to undergo a conformity assessment under MDR in the period from 26 May 2020 to 26 May 2021 but would not be ready for it yet, can in fact breathe a sigh of relief. However, not all transition periods and expiry dates are being moved back by one year, but shall remain with the known dates. In the worst case, this means that even more manufacturers will have to obtain certification in an even shorter time.
As experienced language service providers, creating technical documentation that complies with the requirements of the new MDR is our area of expertise.
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