How Medical Device Manufacturers are Gearing Up for EU Regulations Update

European Union recently implemented Medical Devices Regulation (MDR) which is seen as a step to strengthen the European regulatory system. For long the EU have been enamoured with endless complains regarding its regulations and directives. It has also had to face the wrath of many scandals. For long a need was felt for formulating medical devices regulations that were at part with the advancements seen in medical technology.

While the regulation is set to be completely implemented by 26th May 2021, medical device manufacturers are battling against all odds to revise their strategies to incorporate the new directives. The last time the regulations were updated was over 25 years ago. Though the MedTech industry has welcomed the move, everyone realises how financially straining the compliance is going to be. They will also need to allow adequate manpower to simply adhere to the new rules.

What is the Way Forward?

With very little time left in hand, medical device companies will now have to rethink their strategies to comply with the changes mandated by the MDR. A few preparatory steps that must be immediately taken include -

• Reviewing Current Medical Device Portfolio – Currently medical device manufacturers are adhering to the old certification which allows them to sell their devices. But that won’t be for long. They have to be proactive to adapt to the changing requirements so that in the coming days they do not see any delays and customers face shortages in the market. This can happen when they start reviewing their current medical device portfolio.

• Identify Changing Needs of the Supply Chain – The revised MDR will inadvertently change the workings of the supply chain. Medical device manufacturers will have to identify with the distributors and importers and educate them about the upcoming changes.

• Reworking on the Clinical Evaluation Report – A tedious process that acts almost as a precursor to the revised MDR is the need to rework on the clinical evaluation report. It is a time-consuming work that must be done by companies to meet the new guidelines. Medtech companies can outsource the work to medical literature writers who are qualified for the job.

• Review Existing Agreements – Medical device companies will have to revisit their existing agreements with other companies. Many changes will be necessary for the coming days.

With the implementation of the path-breaking MDR, the industry will see numerous changes. Companies have to start working on bringing about the necessary changes.