Navigating the regulatory landscape

Make the CPSL Life Sciences team part of your Master Implementation Plan for the new Medical Devices Regulation

Building a roadmap for implementation of the new EU Medical Devices Regulation means defining sub-projects like translations, resource requirements, and a steering group, while ensuring overall responsibility. This major undertaking has been hindered by the COVID-19 pandemic, so much so that the European Commission has issued the “Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices” to give the industry a little more time to adapt.

The new Medical Devices Regulation encompasses a wide range of laboratory developed tests, point-of-care devices, instruments, reagents and kits used to analyse human samples and guide clinical decision-making and is far more rigorous and detailed. All these have a crucial role in saving lives by providing innovative medical solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment and alleviation of disease. It is estimated 70% of clinical decisions are made using in vitro diagnostic medical devices.

Because this is such an exciting, fast-moving field, the European Union has reversed its previously lenient stance by introducing the Diagnostic Medical Device Regulation. It is a robust, transparent, predictable and sustainable regulatory process envisaged to raise quality and safety standards with clearer definitions and scope, improving oversight and traceability across the supply chain throughout the device lifecycle. All this will enable the industry to accommodate recent technologies and scientific advances and facilitate global trade by promoting regulatory convergence.

COVID-19 difficulties: notification and NANDO

The new regulation calls for reinforcement of the criteria for the designation and overseeing of notified bodies (a ‘notified body‘ is an independent third-party conformity assessment body). Under the Nando (New Approach Notified and Designated Organisations) Information System, notification is an act whereby a Member State informs the Commission and the other Member States that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive. Notification of Notified Bodies and their withdrawal are the responsibility of the notifying Member State.

Breathing space

The best laid plans of mice and men often go awry (Robert Burns, 1785), and the COVID-19 pandemic has unexpectedly diverted resources and caused delays. The impact of COVID means that there are only six notified bodies designated so far under the In Vitro Diagnostic Medical Device Regulation. This critical shortage of notified body capacity is making it difficult for manufacturers to complete the requisite conformity assessment procedures. There are currently designated notified bodies in only three countries (Germany, France and the Netherlands), making the situation extremely problematic for SMEs in other Member States, which tend to apply to notified bodies in their own or neighbouring Member States.

In response to the unprecedented challenges of the COVID-19 pandemic, Stella Kyriakides, EU Commissioner for Health and Food Safety, made an announcement in October 2021, calling on all manufacturers “to prepare for certification under the new Regulation and not wait until the end of the transition period.” The Commission has nevertheless proposed a progressive roll-out of the IVMDR to account for the impact of the diversion of resources from Member States.

Our experts are here to lighten the load

Despite the postponement, the countdown to the implementation of the In-Vitro Diagnostic Medical Devices Regulation continues, and the current directive, IVDD 98/79/EC is being phased out. That’s why CPSL has a dedicated Life Sciences team working to lighten the load. Industry players are finding CPSL’s expert services invaluable to successfully navigate the demands of the new regulatory standards. The Life Sciences team at CPSL is poised to smooth the transition to all kinds of changes in this rapidly developing industry, and a trusted language partner to bear the burden of managing time-consuming tasks, leaving your experts free to conquer new challenges with clarity and confidence.

The industry has been granted a little more breathing space to account for the effects of the pandemic. That said, the basic requirements have not changed. One feature of the new law is the introduction of a risk-based classification system with four risk classes of in vitro diagnostic medical devices: class A (low individual risk and low public health risk), class B (moderate individual risk and/or low public health risk), class C (high individual risk and/or moderate public health risk) and class D (high individual risk and high public health risk). However, the length of the new proposed transition periods now depends on the type of device, establishing a transition period until May 2025 and 2026 for high-risk devices like HIV and hepatitis tests, allowing until May 2027 for lower risk class B and A sterile devices.

CPSL has the transition assistance you need

Linguistic excellence is always non-negotiable, but never more so than in medical and regulatory matters where everything must be precisely drafted and verified to give the highest of guarantees in matters of life and death. The new regulation accounts for this. For example:

Article 10.10 on General obligations of manufacturers, states that “Manufacturers shall ensure that the device is accompanied by the information […..] in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient. The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.”

Article 37 of the new regulation also deals with language requirements and states that “All documents required pursuant to Articles 34 and 35 shall be drawn up in a language or languages which shall be determined by the Member State concerned. Member States, in applying the first paragraph, shall consider accepting and using a commonly understood language in the medical field, for all or part of the documentation concerned. The Commission shall provide translations of the documentation [……], or parts thereof into an official Union language, such as is necessary for that documentation to be readily understood by the joint assessment team appointed in accordance with Article 35(3).”

The European Union has published a series of dedicated factsheets with a summarised view of the principal areas of activities in the medical devices sector for manufacturers of medical devices and in vitro diagnostic medical devices, urging the industry to make an early start because of the expected pressure on notified bodies. As a global leader in serving the Life Sciences sector, we are fully committed to streamlining regulatory compliance by meeting all your needs – translation, revision, adaptation, and back-translation. We master the latest technologies to ensure consistency and effective terminology management, following strict translation protocols for guaranteed excellence.

If you need assistance with this crucial process, CPSL is your language provider of choice: download our guide to the new MDR now or get in touch to find out how we can assist you.