Are your Class I devices ready for the MDR?

Medical Device Coordination Group provides guidance notes for manufacturers of class I devices

Even with the postponement of the date of application for the Medical Devices Regulation (MDR) to 26 May 2021, manufacturers still need to pay attention to devices for which there are no transitional provisions. In particular, this applies to class I devices that do not need notified body involvement in conformity assessment. The Medical Device Coordination Group (MDCG), which is composed of representatives of Member States and chaired by the EU Commission, has issued Guidance Notes for manufacturers of class I devices. It should be emphasised that the document was issued prior to the postponement of the date of application of the MDR. The guidance cannot be regarded as reflecting the official position of the European Commission, or as being legally binding.

In order to place the device on the market, the manufacturer has to demonstrate conformity with the MDR and compliance with the applicable general safety and performance requirements (GSPRs) laid out in Annex I. Before placing a device on the market, the manufacturer affixes the CE mark and draws up the EU declaration of conformity. In order to complete these tasks, the guidance document lists a number of activities that need to be completed, including:

• Confirm the product is a medical device and its classification;
• Put in place a quality management system (QMS) and a system for risk management;
• Conduct a clinical evaluation;
• Conduct a conformity assessment;
• Draw up and keep up-to-date the necessary technical documentation;
• Ensure that the device is accompanied by the information needed to identify it and its manufacturer, and any relevant safety and performance information. The information has to be provided in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label will need to be indelible, easily legible and clearly comprehensible to the intended user or patient.
• Implement a post-market surveillance system that is an integral part of the manufacturer's QMS, and based on a post-market surveillance plan which is part of the technical documentation;
• Implement a system for recording and reporting incidents and field safety corrective actions;
• Put measures in place to provide sufficient financial coverage in respect of potential liability.

The second corrigendum to the MDR, as updated by the amending regulation postponing the date of application of the MDR, allows devices to be placed on the market or put into service until 26 May 2024 if, under the Medical Devices Directive (MDD), they

• are class I devices;
• have a declaration of conformity drawn up before 26 May 2021;

and under the MDR

• are classified higher; and,
• require the intervention of a notified body.

There are two provisos that apply to class I devices with declarations of conformity to the MDD covered by the second corrigendum.

• firstly, that some requirements of Regulations will apply to devices with valid declarations of conformity under the MDD during this transition period. These MDR requirements include those for post-market surveillance, market surveillance by national authorities, vigilance reporting and registration; and,
• secondly, that no significant changes are made to the device.

There are some elements of the regulation that will not be in place or required on 27 May 2021. The electronic system for registration of economic operators (Eudamed) will not be fully functional. When Eudamed is available, the manufacturer will need to submit the required information to the database. However, until Eudamed is fully operational, the provisions of the Directives regarding exchange of information will continue to apply. In addition, the manufacturer will also need to assign a UDI to the device and, if applicable, to all higher levels of packaging, to allow identification and traceability, by the deadline of 26 May 2025 for class I devices. For reusable class I devices, including the UDI onto the device itself applies from 26 May 2027.

This MDCG guidance note is not a substitute for understanding your requirements under the MDR but, for manufacturers of class I devices, they provide a useful checklist to confirm readiness for the date of application.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development