Zuhal Reed, Esq. | Risk Management Senior Staff Attorney | Medmarc
In October 2021, the Medical Device Coordination Group (MDCG) published a guidance to aid medical device manufacturers in complying with classification rules in the European Medical Device Regulations (EU MDR). The MDCG is a regulatory body that reports directly to the EU commission. This group has no decision making power. They exist purely for advisory and coordination to create medical-device standardization across EU member countries. The objective is to ensure safe and effective use of medical devices and traceability of medical devices. They are also involved with market surveillance. The MDCG is composed of health and industry experts. The group’s guidance documents are seen as EU MDR guidance documents. EU MDR is similar to FDA’s UDI (Unique Device Identifier), and it only came into effect in May 2021. Its purpose is to create a new risk classification system for medical devices. The EU MDR also addresses how to package medical devices, develop instructions for use, and most recently provide patients with an “implant card” that bears information about their implanted medical devices. The aim of such guidance is to promote increased surveillance of medical devices throughout the supply chain.
The recently released guidance is for notified bodies, distributors, and importers. It focuses on how to classify your medical device. Medical devices are placed in 4 classes: class I, IIa, IIb, and III. Class I devices are the lowest risk, and class III are the highest risk devices. There are further categorizations based on whether the device is invasive or not, whether it is a contraceptive, a sterilizer of medical devices, or aesthetic devices that function like a medical device. The guidance delves deep into these classifications to provide clarity and guidance for manufacturers, distributors, and other parties involved in labeling devices by explaining how the risk categories were determined. Further, it provides a multitude of examples of devices in each category that will help a manufacturer determine into which category their device falls.
The guidance also discusses conflicts, or the rare situations where the device is difficult to classify. If there is an issue between the manufacturer’s determination of the correct classification and what the notified body believes is the correct classification for the device, the recommended course of action is to refer to the EU member state’s competent authority. Those competent authorities then have the option to reach out to the MDCG Borderline and Classification Working Group for further guidance.
This guidance document will be helpful for manufacturers and distributors of medical devices that operate inside and outside of the EU. It provides information on how to comply with EU rules on medical device labeling, classification, and packaging.
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