The Medical Devices Regulation (MDR) will be applicable from May 2021.
The aim of MDR, which will be applied directly in all European Member States, replacing the existing EU directives on medical devices and active implantable medical devices, is to introduce a common regulatory framework for the medical devices market throughout the European Union – to set high standards of quality and safety and to harmonize the principles of implementation medical devices for marketing and use.
The European Union’s Medical Device Regulation will affect your medical products and their Instructions for Use (IFUs).
Apart from monitoring more thoroughly the safety profile of the products placed on the market through implementation of a post-market surveillance (PMS) plan, implementing and maintaining a risk management system throughout the lifecycle of a device is also needed. Companies not following the new rules will no longer be allowed to sell their medical products in the European Union.
An increased demand will be placed on manufacturers labelling and packing requirements through the MDR. According to FDA figures there has been a large increase inproduct recalls in the last decade of which 15 percent can be attributed to labelling errors. There will be requirements for manufacturers to have labels ready for immediate printing, thereby reducing the risk of a mass recall. In addition, companies must provide “instructions for use” (IFUs) that correspond to the format as defined by the EU MDR. The IFUs are available in several languages and require authoritative approval leading to significant effort for its management throughout the registration, production, and distribution process. The proposed procedures will enable the distribution process for appropriate IFU’s, making sure they are available in the correct language and updated as required.
MDR – Article 10 – General obligations of manufacturers states that ‘Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.’
The Regulation determines the kind of information that a manufacturer needs to include on a medical device:
- (a) information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer
- (b) any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions
- (c) any information about the expected lifetime of the device and any necessary follow-up
- (d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I. (the overall qualitative and quantitative information on the materials and substances to which patients can be exposed)
Additionally, the Article 18 thereof states that the information shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate. Updates of the information shall be made available to the patient via the website.
To see whether your company is ready for the new MDR, and in order to find gaps within a company, it is recommended that you perform a complete gap analysis. You should start with a gap assessment and evaluation of your current situation considering the type of product and define the required step to achieve compliance to MDR 2017/745. The goal of such MDR analysis is to help a Medical Company like Manufacturer, Distributor, Importer, Authorized Representative or Consultants to implement the new Regulation MDR and IVDR in an easier way. Pharma and life science companies will need to conduct a gap analysis from the linguistic point of view also to determine if any of the EU member state languages are missing in the documentation. If so, a strategy to add those missing languages is required in order to distribute product in those countries.
At SeproTec pharmaceuticals, biotechnology, medical devices, chemistry and healthcare are some of our specialties. We employ the latest technological advances in translation in work processes designed from the ground up to meet the specific needs of life science sector organizations. To learn more about how SeproTec can help you with your multilingual projects, reach out to our global team today.
For further information on the new MDR, https://ec.europa.eu/health/md_sector/new_regulations_en