This piece is part of Lionbridge's series addressing language challenges under the new medical device regulation (MDR) in the E.U. which applies from 26 May 2021. In this blog, we focus on clinical investigations.

On 21 May 2021, the Medical Device Coordination Group (MDCG) released yet another guidance document. This guidance, entitled “MDCG 2021-08 Clinical investigation application/notification documents,” helps manufacturers of medical devices implement the new requirements for clinical investigations under the MDR. It specifically addresses sponsors’ responsibilities to submit an application to every Member State where a device investigation is carried out.

A Workaround Due to Delay of EUDAMED

The guidance is a temporary support and recommendation to sponsors until the EUDAMED module for clinical investigations is fully functional from May 2022 which coincides with the Date of Application of the new in vitro diagnostic medical devices regulation (Regulation (EU) 2017/746). According to Article 73 of the MDR, all applications or notifications for clinical investigations are required to be submitted via EUDAMED.

In the absence of a fully functional EUDAMED, the MDCG offers templates including application and notification forms as well as information on documents to submit in a clinical investigation application. Since the templates contain the same data fields that will be required for the EUDAMED system, the intention clearly is to prepare sponsors for working in the EUDAMED module and facilitate a smooth transition.

National Requirements Remain Relevant Under the MDR

The intent of the MDR is to drive harmonization across the European Union. This is partly by changing its legal status from Directives to a Regulation and partly by enforcing a set of general safety and performance requirements on medical devices made available in the European Union. However, even with this harmonization, some bioethical and operational aspects of clinical investigations will remain national matters determined by individual Member States.

Because of these country-level requirements, sponsors still need to check any specific local requirements with National Competent Authorities. This applies for language requirements as well. Not all National Competent Authorities across the EU Member States have provided guidance in preparation for the Date of Application of the MDR on specific local requirements.

A Danish Textbook Example of MDR Implementation

One entity that has done this is the Danish Medicines Agency (DMA). According to the DMA’s Strategy for 2017-2021, the agency’s ambition is to be a key driver in the European collaboration during preparatory legislative work. Denmark is recognized as a country with an extremely high standard in life sciences.

On 21 May 2021, the same date that the MDCG guidance was released, the Danish Medicines Agency released a regulatory guidance entitled “Vejledning om ansøgning om tilladelse til klinisk afprøvning af medicinsk udstyr” (guidance on the authorization for clinical investigations of medical devices). The guidance specifies both MDR and Danish national requirements on medical devices, and how any sponsor that wishes to carry out a clinical investigation in Denmark must comply with both union and national requirements.

In the Danish legal implementation of MDR, the clinical investigation application may be submitted in Danish or in English except for documents that are intended either for Ethics Committee approval or for trial participants which must be in Danish language. These documents include a synopsis of the clinical investigation, Informed Consent documents and all other information intended for trial participants such as instructions and recruitment materials.

Also, labeling and instructions for use are required in Danish and must contain a specific phrase in Danish to indicate that the device is for clinical investigation only: “udelukkende til klinisk afprøvning”. In the application form available on the Danish Medicines Agency’s website, the title of the clinical investigation plan (the protocol) is also required in Danish.

Implementation: A Continued Challenge After MDR Application

While a lot of work has already gone into transitioning to the new regulations before the Date of Application on 26 May, there are still some roadblocks and workarounds ahead before compliance readiness can be fully obtained across the ecosystem of medical devices in Europe.

In reality, many sponsors, regulators and economic operators will remain in a transition phase for a period of time. This means that national Member State requirements on local aspects such as language are likely to remain a burden or even complicate a seamless MDR implementation. In this period, it is a good idea to partner with a language service provider to explore which language requirements may be harmonized or centralized across the device portfolio while still complying with national requirements.

Flexibility and Compliance Expertise

Lionbridge is precisely that type of a provider and is well-equipped to manage a broad cross-section of regulations. Our decades in the industry mean more insights for you. Even more importantly, working with Lionbridge means efficiencies gleaned from smooth onboarding and scaling across functional divisions. We can guide you on when to use machine translations and when you need an on-the-ground expert.

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