Medical Device Regulation (MDR)
Medical Device Regulation (MDR) – new regulations for the medical sector
On 26 May 2021, the new Medical Device Regulation (MDR) will enter into force. Under this Regulation, manufacturers selling medical devices within the EU will be subject to additional requirements in order to guarantee the safety of certain medical aids, implantable medical devices, instruments, etc. To date, this sub-area within the field of medical care has been somewhat less strictly regulated by the German Act on Medical Devices (MPG) than (for example) the regulations governing the handling of drugs by the pharmaceutical industry.
Here are the five most important points to note:
- Who will be affected?
Manufacturers of medical devices that sell their products within the EU
- What needs to be adapted?
Instruction manuals, labelling, packaging, technical documents
- What needs to be taken into account?
The guidelines of the Medical Device Regulation (MDR) and the EU Regulation on In-Vitro Diagnostic Medical Medices (IVDR) must be observed
- When must the materials be adapted by?
26 May 2021
- What will the consequences be if the deadline is not adhered to?
There is a risk of criminal proceedings and thus the danger that the medical devices may no longer be sold in EU countries
What changes will accompany the new Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR) is an EU-wide corpus of requirements governing medical devices. This new regulation was adopted by the European Commission back in 2017; initially, a transition period of three years was agreed for medical devices that have already been approved. In other words, a deadline of 26 May 2020 was set in order to give manufacturers enough time to be able to fulfil the new MDR requirements. But due to the global crisis resulting from the COVID-19 pandemic, the deadline was extended by one year to 26 May 2021, when the new regulation will go into effect. The German Act on Medical Devices (MPG) and the CE seal have been adapted to include the new additions found in the MPR.
The MDR imposes a variety of additional requirements on manufacturers with the goal of ensuring the safe application of certain medical aids, implantable prostheses, instruments and the like. To date, this sub-area within the field of medical care has been somewhat less strictly regulated by the German Act on Medical Devices (MPG) than (for example) the regulations governing medicinal products in the pharmaceutical industry. However, ensuring a high level of safety is equally essential for medical devices intended for use on patients. Now the regulatory bodies of Europe are acting to codify this priority into law. The MDR contains regulations for the following areas, among others:
- Information on products
- Information on the use of instruction and operating manuals
- Information on identification and labelling
- Controlled clinical trials and clinical data evidence
- Reviews of compliance with the MDR regulations are carried out by “notified bodies”
There is also a new directive on in-vitro diagnostics in the works. This regulation will enter into force on 26 May 2022. The IVD Directive (IVDR) aims to provide greater safety and traceability of products throughout the product life-cycle and especially within the supply chain through new classifications, performance evaluations, quality-management systems and expanded technical documentation. From information for any departments and stakeholders involved in this area to internal communications or comprehensive training materials for all employees – it goes without saying that tolingo will of course provide you with reliable and competent support for your translation needs relating to the IVDR!
Who will be affected by this change?
Above all, the new MDR is most relevant for manufacturers of medical devices which are sold in the EU. The new requirements stipulate that they must collect certain types of data on their products and make this available. Furthermore, they must pass this information on to the entire supply chain, all the way to the user or patient – using easy-to-understand wording and in all the necessary languages. Distributors and importers of medical devices operating in the European Economic Area will also be held accountable. Any company that distributes a product affected by the new law within a member state of the European Union is also responsible for providing the required documentation in accordance with the applicable requirements – unless the manufacturer provides this itself.
The manufacturer, dealer or importer responsible for adapting the products must make all information regarding this available to the responsible authority in the respective EU member state – the “notified body” – at least 28 days before the products are to be first sold on the market. Many companies involved in this process have reported that they found the requirements and stipulations within the MDR to be both extensive and stringent. However, they are undeniably appropriate and logical when one considers their significance for the user and for patient safety.
What are the consequences of failing to comply with the new regulation?
Manufacturers and other stakeholders who fail to implement the requirements of the MDR by the deadline can expect to no longer be allowed to distribute their medical devices in the EU. In this case, the notified bodies have the power to arrange for distribution and use to be suspended until all the requirements have been met.
A ban on sales of this extent could result in a significant loss of revenue. For this reason, manufacturers as well as importers and distributors should note that the MDR also entails changes in the classification of medical devices. In other words, certain products that may not have been classified as medical products under the MPG may well be included under the new MDR. If your company is a manufacturer or dealer, you should therefore immediately review your entire range of medical devices in all classes (class III, class IIa, etc.) and verify whether certain documents need to be adapted and/or translated.
How can we support you?
As an ISO 17100 and ISO 9001 certified translation agency with extensive knowledge of the Medical Device Regulation (MDR) and the Regulation on In-Vitro Diagnostic Medical Devices (IVDR), tolingo is able to offer you professional support by providing clear and compliant translation of all materials for your medical devices in all official EU languages. If you need medical translations for all documents relating to your medical products, simply contact us and we will provide you with a non-binding quote.