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EU Medical Device Regulation

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Author: Mark Hodgson
Practice Leader, Life Sciences, LanguageWire

EU Medical Device Regulation

EU Medical Device Regulation

This blog was updated on 01-05-2020 to reflect the new date of application for the EU MDR.

In May 2017, the European Union published two new regulations, the Medical Device Regulation (MDR), and the In Vitro Diagnostic Device Regulation (IVDR). These two regulations will replace the current directives, with a three-year transition period for the MDR and a five-year transition period for the IVDR.

Manufacturers of medical devices must show clinical evidence of safety and effectiveness, which marked the initiation of this three-year transition period for those selling their medical devices across Europe.

With a deadline of 26 May 2021, the clock is ticking away for manufacturers and distributors of medical devices in the EU to ensure that their data and documentation meet the new requirements.

  • Many organisations are behind in their readiness for the MDR. Source documentation must be updated and then translated into 24 languages in order to be able to sell the devices to EU countries.

Much of this new content can be found in the IFUs (Instructions for Use) and medical device manuals, to name a few.

Manufacturers are under immense pressure to update their documentation into the relevant languages. At LanguageWire we are working with our customers to ensure their content is translated in time to meet these requirements.

These new regulations have also introduced a Unique Device Identification (UDI) System, which will help in the traceability of all medical devices sold across the EU. These devices need to be marked with a device identifier and each batch series of a product will now need to be marked with a production identifier.

Devices which fall under Class IIa/IIb and Class III will have their UDI recorded, indexed and registered on the central EU database EUDAMED – the European Database for Medical Devices. The new database was initially planned to go live in March 2020. However, the European Commission decided to launch the database for both medical devices and in-vitro diagnostic devices simultaneously in May 2022.

Within the MDR guidance, manufacturers also need to establish, implement and create documentation within a quality management system (QMS) and maintain its efficacy throughout the medical device’s lifecycle (this quality management system needs to be in accordance with ISO 13485 for MDR as well as for IVDR).

QMS procedures will need to cover the following

  1. Quality objectives and the organisation of the business
  2. How procedures and techniques are used for controlling design, validation and verification/review of medical devices
  3. Relevant clinical trials and tests documents are to be stored
  4. Post-market surveillance
  5. How risk assessments are carried out for new and existing devices
  6. Manufacturers need to have an appointed individual responsible for regulatory compliance (shown in Article 15 of the MDR and IVDR)
  7. Ample financial coverage regarding a manufacturer’s potential liability (shown in Article 10 of the MDR and IVDR).

For IVDR, this will also create the following key changes for manufacturers

  1. The testing and performance will need to be checked and verified by referenced laboratories for Class D medical devices.
  2. Contiguous evidence of the medical device’s performance throughout the life of the product will need to be provided.
  3. Conformity assessments will need to be carried out by specific notified bodies for the majority of IVDs.

LanguageWire is one of the world’s leading providers of language services. We are here to guide you through the process of delivering multilingual content to ensure that your content meets the new EU regulations.

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