The EU regulation 2017/745 (MDR) and 2017/746 (IVDR) for medical devices provide detailed protocols for the rigorous and comprehensive Quality Management System to verify and assure the safety, performance, reliability, and quality of medical devices available in the European Union. This regulation also focuses on a comprehensive and post-authorization measure known as Periodic Safety Update Report (PSUR). PSUR is a crucial aspect that helps drug regulatory authorities to monitor the safety and performance of the medical devices available to the public.
The Periodic Safety Update Report (PSUR) includes continual safety and benefit information updates and a detailed assessment of the general risk-benefit profile relevant to that medical device. Manufacturers must provide this information to the notified bodies of the EU to maintain their marketing authorization for medical devices. To ensure product performance, reliability, and safety, an extended type of PSUR known as PRRC must be completed within the specified timeline established by the authorities.
When it comes to protecting the interests of consumers and ensuring fair competition in the European market, a person responsible for regulatory compliance must be in place. Under the 2017/745 and 2017/746 regulations, companies must have someone in a position to analyze and evaluate the day-to-day regulatory compliance of the business.
This person is responsible for staying up to date with all regulatory changes and developing new protocols and processes to ensure compliance. They must also be able to quickly recognize any potential issues and take corrective action, as well as have an in-depth knowledge of the regulations and how they apply to the business.
The person responsible for regulatory compliance must keep precise records, notes, and communication for internal and external review. They must ensure that all regulations are met and stay in contact with government and regulatory bodies when necessary.
On top of all this, they must also be able to monitor and coach employees on proper procedures to ensure compliance is consistently maintained. It's the person responsible for regulatory compliance's job to prevent the company under their watch from potential fines or sanctions should they not be compliant.
Ultimately, this person plays a critical role in maintaining regulatory compliance, ensuring the best interests of consumers, and fair competition in Europe's market.
Recent reports have revealed that the implementation of the 2017/745 MDR regulation, mandating that all EU medical device products be certified by 26 May 2024, is extended to 31 December 2027 or 2028. The Commission proposes a new transition period for class III custom-made implantable devices until 26 May 2026.
Many manufacturers are now facing additional challenges and uncertainties while they adjust to the new timeline. Factory output, supply chain management, financial matters, and the coordination of further testing and certification requirements are just some facets that require careful consideration.
An uncertain climate such as this can bring about several complexities for medical device companies. Those making significant organizational and structural changes may need more time to carry out their plans effectively in the allocated timeframe.
Though the delay of the MDR will provide some leeway for medical companies to navigate these uncertainties, it is still essential for manufacturers to remain vigilant and start taking necessary steps toward compliance sooner rather than later.
Fortunately, the extra year allows more time to carry out the necessary tests and certification processes, which may lead to a smoother and more successful MDR transition. With the current situation in mind, manufacturers should remain mindful of the deadline to ensure smooth progress and successful completion of the MDR.