WHAT IS MDR?
MDR FAQ
GENERAL FAQs
STEPS TO MDR CERTIFICATION
MDR = Medical Device Regulation
The MDR replaces the former MDD (Medical Device Directive) and introduces an EU-wide legislation to ensure the quality, safety, traceability and reliability of medical devices. The MDR regulates the approval of medical devices on the EU market. Countries outside the European Union which use the CE-Mark as quality seal, are also affected by the MDR.
The MDR was published on May 5th 2017. It was initially planned to be legally binding from May 26th 2021. But due to the Covid-Pandemia and further bottlenecks in implementation the binding date was moved to May 26th 2024.
The introduction of the MDR pursues various objectives. On the one hand, it aims to improve the coordination between the EU member states. On the other hand, it aims to promote the safe use of medical devices for patients, and thus the service life of the devices.
The regulation replaces previously valid directives the MDD (Medical Device Directive 93/42/EEC) or the AIMDD (Directive on Active Implantable Medical Devices). All medical devices that are currently MDD or AIMDD certified must be re-evaluated. If the transition to MDR is intended and agreed with the notified body, products that currently comply with the MDD remain useable and can be legally marketed until end of 2027. Products which are not intended to be transferred but already in stock in healthcare facilities can be used until they expire.
Medical devices of all classes and active implantable medical devices are affected by the new regulation. The definition of medical devices has been significantly expanded and now also includes products without a medical purpose, such as colored contact lenses. Aids such as wheelchairs, hearing aids, prostheses and software programs for medical purposes, such as imaging software and electronic patient records, also fall under the definition of medical devices.
All products in the portfolio must be checked against the new classification and technical data must be updated accordingly. Depending on the product class, different requirements must be met. For example, for class III medical devices, clinical investigations must be carried out to demonstrate the required safety and performance of a product. Manufacturers are also obliged to collect and store clinical data on potential safety risks.
An important factor of the MDR is greater transparency, both for healthcare professionals and for patients. Therefore, the Unique Device Identifier (UID) and a central database (EUDAMED) are introduced. Patients will now have direct access to valuable information on a specific product.
Each manufacturer is also obliged to implement its own patient website, which is specially tailored to the needs of patients and presents relevant content in an easily understandable way.
Manufacturers of implantable products are obliged to provide patients with an implantation card.
EUDAMED, the “European Database on Medical Devices”, is an EU-wide database that includes all MDR-certified medical devices and provides relevant information on the individual products. There is a public page for patients and the general public, as well as a separate restricted area for healthcare providers.
With the UDI (Unique Device Identification), a 14-digit number, each device is uniquely identifiable. The UDI can be found for example on the identification card and enables the easy identification of a product in EUDAMED.
The implantation card is an indispensable tool for ensuring patient safety and the traceability of implantable medical devices. It helps to ensure that the patient and healthcare professionals always have the necessary information to safely handle an implanted device and is an important component in the monitoring and regulation of medical devices under the MDR.
WHICH STEPS ARE NECESSARY TO REACH MDR CERTIFICATION FOR A MEDICAL DEVIC
In the first step, the risk class of a product must be determined. The products are divided into different classes based on the requirements of the MDR Regulation. Class I is the class with the lowest risk, class III products have the highest risk.
Depending on the risk, the products are assessed in different ways. Class III products, for example, must not only be tested by a notified body, but must also fulfil additional requirements such as clinical testing and the assessment of the notified body needs to be confirmed from an expert group in the European Commission before the CE certificate can be issued.
Detailed technical documentation must be prepared for each product. In addition to aspects such as product description and instructions for use, this also includes documentation on risk management, results of clinical evaluations and more.
A clinical evaluation must be carried out to demonstrate the safety and performance of a device. This is an essential part of MDR certification for devices in the higher risk classes. The clinical evaluation includes also the final definition of the intended use which can be determined as safe and efficient.
A notified body is a certified testing and certification organization, such as TÜV. Class IIa, IIb and III devices must be verified by a notified body on the basis of their technical documentation and their compliance with the requirements of the MDR.
The notified body also audits the manufacturer's quality management system to ensure continuous production in accordance with the requirements of the MDR.
If the testing and auditing by the notified body is successful, the manufacturer can issue an EU declaration of conformity for its product, which authorizes its sale on the EU market.
The CE marking indicates that the product can be sold in the EU. As soon as the declaration of conformity has been issued for a product, it may be labelled with the CE marking.
After market launch, the performance and safety of a product must be continuously monitored through the lifecycle of a product, for example by collecting and analyzing feedback from the market. If necessary, corrective actions must be taken and serious incidents or safety problems must be reported to the respective authority.
In order to maintain conformity, the notified body may carry out audits and verifications at any time after market introduction.
Further Information – MDR legislation
RE-CERTIFICATION PROCESS
These products are curently in the Re-Certification Process
