The MedTech industry is undergoing extensive changes with the advent of the European Union Medical Device Regulation (EU-MDR) framework, a comprehensive set of regulations being implemented across Europe. It establishes more stringent requirements to mitigate the negative impact of hazardous substances in medical devices on human health or the environment.

These regulations have placed the burden on MedTech companies to update regulatory documents and adhere to notified guidelines. As a result, original equipment manufacturers (OEMs) are looking at outside delivery and technology-based partners to assist in document submission and to bring in value propositions to hasten the release and sustenance of the medical devices.

Impact of the EU-MDR on MedTech landscape

According to the US International Trade Commission (USITC), US companies are the biggest suppliers of medical devices to the European market. The new EU regulations have created challenges for the medical devices manufacturers such as additional compliance costs, regulatory uncertainty and possible delays to market approval.

With the documentation process becoming more stringent, organizations must review the documents for devices already in the market. Consequently, the demand for qualified professionals who can help devices makers to fulfil the compliance requirements has increased too.

“These professionals play a key role in collecting information on device input, clinical studies and risk data and bulleting all the information,” said Dr. Padma Priya Putrevu, General Manager, Engineering and R&D Services at HCLTech.

This new regulatory framework applies to medical devices approved under the old Medical Device Directive (MDD) framework. Those devices currently sold and used in the EU must go through the approval process again to meet EU-MDR regulations. In less than two years, all regulatory approvals issued under the old MDD framework will become invalid so all medical devices currently sold and used in the EU will need to be resubmitted for approval. This is a challenge that hits small- and medium-sized manufacturers hardest.

Another challenge for medical device manufacturers is that compliance with MDD doesn’t guarantee compliance under EU-MDR, which has more strict and complex regulations in a range of areas.

The length of time it takes to apply for and obtain approval under the new MDR is about twice as long as it was previously and, according to research by MedTech Europe in April 2022, there’s an anticipated approval bottleneck of over 85% as more than 500,000 medical devices certified under MDD have yet to receive MDR certification.

Furthermore, manufacturers can benefit from enhancing quality systems and introducing new procedures for document storage, post-market surveillance and risk assessments for their products. Making these enhancements is key because notified bodies will review product data to provide certifications, review quality management systems to ensure data quality and accuracy and make recommendations for remediation.  

Adding value with external partners

The burden of ensuring compliance with EU-MDR has not only impacted MedTech companies, but regulators as well. By utilizing external partners, efficiencies can be brought into the process for achieving compliance.

“If you look into the kind of work that is being involved now, the OEMs don’t have sufficient expertise in house to do these documents and, right now, most clients are in the maintenance phase and definitely looking for a partner who will help them complete it in the least possible time with the highest quality,” said Dr. Putrevu. “At the same time, these partners would help them in notified body reviews.”

HCLTech’s enterprise MDR is an end-to-end standards management solution for clinical data that spans protocol to submission with built-in traceability that can help introduce greater efficiency to regulatory compliance. The metadata-driven approach assists with refining protocol design, study setup, data collection and analysis while creating submission-ready deliverables.

It may take a few years for the industry to get to a stage where they can consistently and effectively adhere to MDR compliance, according to Dr. Putrevu.

It will require new strategies and policies to be implemented for documentation submission. Huge demands on evidence-generation systems will need to be expanded or re-designed and these will require a high level of expertise and partnerships to jumpstart progress.

Enlisting the support of partners who are experts in the field can provide reassurance that manufacturers will meet obligations at reduced costs and ease the pressure on internal teams.