The beginning is the most important part of the work” – Plato

Exhale. The regulatory affairs team has successfully managed to bring the required portfolio data into a state of compliance to meet the portentous date, 26 May 2021. Surely the cross-functional teams and key stakeholders have celebrated the end of the programme and are now ready to move on to the next business target.

Stop, right, there.

The difficult work is just starting. The act of maintaining MDR compliance now represents one of the biggest challenges for Medical Device companies entering or continuing business in the European market. Survival dictates establishment of a sustainable MDR continuation plan for successful and long-term business stability.

Maintaining company awareness that compliance to the MDR “is not just for Christmas” is critical.

Preparation for a stable continuity plan entails bringing together internal and external stakeholders across the entire device supply chain to ensure the correct communications and data infrastructure are utilised. Regulatory affairs teams will need to implement effective delivery methods for continued company-wide information exchanges and to track on-going progress and processes. The usual workarounds and patchy gap filling process will eventually become not fit for purpose.

As with most change, compliance to MDR will cause major disruptions, possibly cause significant increases in internal spending, resulting in a possible reduction in product revenue potential and reduce availability of investments in R&D. Senior management decision makers must allow regulatory affairs teams to engage in approaches to minimise the possible negative effects attributed to conformity to the regulations.

MDR is pushing medical device companies, their regulatory teams and supply chain partners to actively embrace integrated solutions for effective data access, visibility, management and governance. Innovative digital technologies can support the newly implemented regulatory requirements for increased data volume and speed of data transmission whilst maintaining data integrity. When software solutions are implemented, costs are decreased as regulatory professionals are able to apply their skills and knowledge to developing regulatory strategy and other significant value-adding activities rather than completing rote data administrative tasks.

MDR has shifted the legislative enforcement spotlight from approvals to encompassing the entire medical device life-cycle management as a means to engender increased device safety, effectiveness and transparency throughout the European medical device market. Integrated solutions will support industry in meeting those requirements for greater transparency, identification, traceability though to continuous postmarket surveillance.

It is clear from monitoring the association websites, guidelines, conferences and social media, that all European medical device industry players — manufacturers, NBs, PRRCs, ARs, importers, distributors— must invest heavily in their respective application of the new regulations, or risk considerable financial and competitive losses.

“The secret to change is to focus all of your energy, not on fighting the old, but on building the new.” -Socrates

KimYoung@instem.com

K Young