Light the Way: Navigate the Regulatory Grey

welocalize September 30, 2019

Highlights and key takeaways from 2019 RAPS Regulatory Convergence

RAPS Regulatory Convergence is focused exclusively on regulatory for the healthcare products industry. Some key topics and trends for this year included a strong focus on navigating regulatory changes and challenges, including the new EU Medical Devices Regulations (MDR) set to go into effect May 2020, and the in vitro diagnostic regulation (IVDR), taking effect two years later.

The Welocalize Life Sciences team was on the ground in Philadelphia for RAPS Regulatory Convergence 2019. Here are the highlights and key takeaways.

EU MDR 2020

EU MDR, which began a 5-year pre-implementation period in 2017, will be fully adopted in 2022. However, the introduction of a EU Database for Medical Devices (EUDAMED) is on track to launch in 2020.  All medical device companies that sell medical products in Europe must adhere to the new regulation. Companies that do not follow this regulation will not be allowed to sell their medical products in the EU after May 26, 2020.

The processes, changes, timelines, and potential repercussions were all front of mind at RAPS 2019.

Recent updates include a decision by the commission to launch the database simultaneously for both medical devices and in-vitro diagnostics together in May 2022. According to RAPS Regulatory Focus™, the two-year delay of the database for medical devices (the commission reiterated that date of application of the Medical Devices Regulation (MDR) remains May 2020) effectively means that device manufacturers can postpone their entering of data into Eudamed.

As this first milestone fast approaches, many of our industry peers are preparing for new safety, performance, labeling, and post-market surveillance requirements. Welocalize Life Sciences had many conversations about the impact of the new regulation. For example, there are specific language and readability requirements, as follows:

Manufacturers shall ensure 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 particulars on the label shall be indelible, easily legible, clearly comprehensible to the intended user or patient.

Take note: The definition of ‘label’ has expanded to include items such as multi-language booklets and Instructions for Use (IFUs). In this Pharma Times article, there is an excellent summary detailing the ins and outs of the new requirements, as they relate to labels.

WARNING SIGNS

Several experts warned RAPS attendees about what’s to come. Bassil Akra, VP of notified body TÜV SÜD (which recently became the fifth designated NB), explained how even if the European Commission designates 20 notified bodies by next May, the workload will not be doable, especially as companies have to deal with the old and new regulatory systems simultaneously.

THE REGULATORY “GREY”

The RAPS 2019 poster display featured themes for navigating the regulatory grey, including innovation, change, and communication.

More than anything, the key takeaway from RAPS 2019 is that the industry is opening up to new ideas, technologies, and collaboration initiatives to help navigate the regulatory grey. In addition, years of discussions around the pending EU MDR requirements are no longer three or five years away. The future is now.

How can Welocalize Life Sciences help?

EU MDR 2020: Welocalize Life Sciences has over 20 years of clinical and regulatory translation expertise, including the translation of surgical protocols, IFUs, package leaflets, and dossiers, for the 24 EU-recognized land required languages for EUDAMED.

See you at RAPS 2020!

marty karen cristobal at RAPS 2019
Left to right: Marty Carl, Karen Leyton, and Cristóbal Pérez