Conformity assessment in the European Economic Area - The long road to a certified medical device
As a certified manufacturer and developer of medical devices, we deal with the high quality requirements for our X-ray systems and software solutions every day in order to guarantee their safety and reliability.
Every medical device that is placed on the market in the European Economic Area must fulfil high quality standards. The safety of patients and users is clearly top priority. With the introduction of the EU Medical Device Regulation (MDR), two previously applicable directives, the Medical Device Directive (MDD) and the Active Implantable Medical Devices (AIMD), have been replaced. In this article, we would like to summarise the requirements that this entails and the processes that must be completed before a medical device receives approval.
A certified medical device that fulfils all legal requirements receives a CE mark. Whether these requirements are met is checked in advance in a conformity assessment procedure. The individual steps involved depend largely on the risk characteristics of the product. The requirements placed, for example, on the technical documentation, the quality management system of the respective manufacturer or the type are based on this. For example, the requirements for the technical documentation were significantly increased during the changeover to the MDR. This documentation is now required to be more comprehensive and detailed.
The risk classification of medical devices is based on the intended purpose and the inherent risk of a product and is divided into classes I, IIa, IIb and III in accordance with EU-MDR Annex VIII. The higher the risk, the more evidence of safety and performance over the entire product life cycle is required. All EXAMION products correspond to risk class IIb (medium risk) in accordance with the classification rules and implementing regulations.
Regardless of the risk class, safety and performance must be proven by a clinical evaluation, i.e. a process for the continuous collection and evaluation of clinical data. This evidence is provided with the help of literature, experience values or clinical trials. Post-market clinical follow-up is also required. The clinical evaluation is an essential part of the conformity assessment procedure for CE marking and must take place before the medical devices are authorised and placed on the market.
Conformity assessment therefore not only focusses on the status quo of the product. Rather, the focus is on the processes through which safety, functionality and effectiveness are to be guaranteed consistently and in the long term. A key component of this is post-market surveillance, the monitoring of products after they have been placed on the market. This is a systematic process from which corrective and preventive measures are derived when necessary. In this way, potential risks should be identified in time and effectively minimised. The performance of the products is thus permanently checked under conditions of use and any safety deficiencies are recognised as quickly as possible. This process includes continuous data collection and analysis as well as follow-up measures if required. Based on the data, a clinical evaluation file or risk management file must be constantly updated, in which the results are reported. This requires a vigilance system, i.e. a system that defines how any incidents are reported to the relevant competent authoritie
For the majority of medical devices (all from risk class IIa), a notified body is involved in the assessment procedure, which issues a certificate of conformity after the review and if all requirements are met. The Notified Bodies are in turn monitored by The Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices (ZLG). The activities and test certificates of the notified bodies were standardised at EU level with the introduction of the MDR. Our quality management is also regularly reviewed in external audits by our Notified Body DNV (Notified Body 2460). Our ISO 13485:2016 certificate confirms its effectiveness. In addition, we undergo internal audits in order to fully fulfil our high quality standards.
The changeover from the MDD to the MDR is intended to create more transparency in market surveillance. For example, the information stored in the European Database on Medical Devices (EUDAMED) will be made available to a larger group of people. The authorities therefore have faster access to relevant information and can react more quickly if necessary.
As a medical device manufacturer, we guarantee that our products meet the highest standards. With our quality management system, we at EXAMION strive to continuously optimise our own processes and procedures. Patient safety when using our digital X-ray systems is our top priority. Every day we do our best to achieve this.