The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published several guidances.
MDCG Issued New Guidance Regarding Class II Medical Devices
The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published several guidances. The first guidance clarifies the requirements for the sampling of the Class IIa/b medical devices under the Medical Devices Regulation 2017/745 (MDR) and also the Class B/C in vitro diagnostic medical devices under the In Vitro Diagnostic Regulation 2017/746 (IVDR). The second guidance is dedicated to codification under the MDR.
Sampling: an Overview
The first of the two guidances issued by the MDCG provides additional details regarding the requirements that apply to samples of medical devices subject to review. The manufacturer should provide this in the course of the application procedure. The document describes the criteria and how they should be used when assessing technical documentation. It also covers the tasks that the notified body should perform during the process.
Since neither MDR nor IVDR provides definitions for several important categories, the guidance contains the definitions as well as a notice that these definitions are provided exclusively for the purpose of this guidance. The document contains the following definitions:
- Category of devices – the devices with the same MDA/MDN codes for general medical devices and IVR codes for in vitro diagnostic devices,
- Generic device group refers to the 4th level of the European Nomenclature of Medical Devices (ENMD) for devices regulated under the MDR and the 3rd level of the ENMD for the devices regulated under the IVDR respectively,
- Device range – includes all the devices covered by a particular certificate
MDA/MDN and IVR codes are special combinations of codes accompanied by a four-digit number and used to identify the appropriate type of devices. The number is used to display connections existing between devices. In other words, similar numbers in the code indicate that these devices belong to different subcategories inside the main category. European Nomenclature of Medical Devices (ENMD) is a code-based system introduced to simplify the exchange of information regarding particular medical devices and to simplify communications between national authorities and other parties involved in different countries. Due to the ENMD, the numeric code assigned to the type of devices helps deal with the language barriers and possible associated mistakes. The unified nomenclature could entirely replace most of the existing local codification systems currently used.
According to the MDR and IVDR, it is necessary to provide one device for each category of devices for Class IIa / Class B medical devices while it is required to provide one device from each generic group of Class IIb / Class C medical devices. In this case, the assessment procedure covers not only the quality management system but the technical documentation regarding the provided sample devices too.
The most important part of the guidance covers the aspects related to sampling criteria. During the assessment process the notified body should check whether the application meets the following criteria:
- Quantitative sampling criteria includes both sampling from before the QMS certificate being issued and also sampling from during the surveillance procedure. The notified body has to ensure that the existing certificate covers the whole range of the devices necessary under the scope of the submission. The exact number of samples to be provided should be calculated in accordance with the representation principle. The number of sample devices should also be proportional to the entire number of the devices covered by the certificate. In general, approximately 15% of the devices from each category should be sampled. If there are only a few devices included in the certificate or the appropriate technical documentation has been already assessed by a notified body, it would focus on the information on the post-marketing surveillance and data collected in the course of adverse events reporting.
- Qualitative sampling criteria is the group of criteria related to design, manufacturing processes and sterilization methods utilized, the novelty of the technology and intended purpose, etc. It is provided that the notified body must apply the appropriate qualitative sampling criteria depending on the particular device subject to review and its specific features, such as physical, chemical or other properties. The notified body should also evaluate the risk associated with the device. Due to this principle, the assessment procedure for the entirely new devices would be much more rigorous than for devices similar to ones already present at the market.
It is also noted in the guidance that sampling is not a one-time procedure – the notified body may require the manufacturer to provide samples of the device during its whole lifecycle. In most cases, additional samples will be requested in the course of special investigation in response to adverse event reports or if substantial changes were made to the device after the initial assessment.
Assessment of Technical Documentation
According to the guidance, the assessment of all Class II (a+b) and Class B / Class C medical devices should be as detailed as the procedure for higher classes, such as Class III or Class D. The documentation is subject to review under the General Safety and Performance requirements while all final information should be provided in a form allowing any third party to use it if necessary. The guidance also emphasizes that the notified body should pay attention to the variations of the particular device (e.g. size), how they are described in technical documentation and how such variations impact other features of the device. In accordance with the general rule, the application for and issuance of an EU technical documentation assessment certificate for Class IIa / Class IIb and Class B / Class C medical devices is not necessary.
At the same time, there are special requirements provided for certain types of medical devices. For example, Class IIb implantable medical devices are exempt from sampling while it is required to obtain an EU technical documentation assessment certificate for such devices. Another exemption is related to Class IIb active administering devices that should pass clinical trials prior to being eligible for further assessment. It is required to provide special Clinical Evaluation Assessment Report, that should be uploaded to the online database.
All important information related to sampling should be included in the sampling plan. The manufacturer is obliged to notify if any changes were made to the device itself. In this case, the notified body would have to amend the sampling plan to keep information on the sampling plan valid and up-to-date. To improve the communications between the manufacturer and the notified body, the guidance sets forth the rules that the manufacturer should provide access to the technical documentation while the notified body shall provide the manufacturer with the detailed report finalizing the evaluation.
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