The MDR Deadline Has Passed: Is Your Company Compliant?
As of May 26th this year, the new Medical Device Regulation (MDR) has come into effect, bringing significant changes and challenges for medical device companies operating within the European Union and the United Kingdom. With the deadline now passed, the question arises: Is your company compliant with the new regulations? Failure to comply means that a company cannot bring its medical devices to market.
Under the MDR, the regulatory landscape has undergone a significant shift. Previously, Class 1 medical devices were considered low risk and could be released onto the market without the need for extensive sign-off. However, with the implementation of the MDR, every medical device, regardless of its class, must undergo careful certification processes to ensure compliance and safety standards are met before being authorised for sale.
The introduction of the MDR coincided with the complexities of Brexit, further complicating the situation for medical device companies. With the UK’s departure from the European Union, the use of the CE marking, previously required for medical devices sold in the EU, is no longer recognised in the UK market. Instead, UK companies must now adhere to the UKCA marking for products sold domestically, adding an additional layer of regulatory compliance requirements.
To achieve compliance with the MDR, companies need to establish regulatory teams equipped to navigate the regulatory landscape. These teams are responsible for creating technical files that document every aspect of the medical device, including its clinical trial data, research and development processes and risk assessments. These files are then submitted to notified bodies for thorough review and approval before the product can be placed on the market.
The MDR also necessitates the updating of existing technical files to align with the new regulatory requirements. This process involves revisiting the technical documentation, including clinical trial protocols, biological reports, and Clinical Evaluation Reports (CERs), to ensure they meet the stringent criteria set forth by the MDR.
In navigating the transition to MDR compliance, regulatory professionals are a key part in ensuring that companies adhere to the new regulatory standards. From drafting and updating documents to establishing and implementing compliant policies and procedures, regulatory experts are instrumental in guiding companies through the regulatory landscape.
As medical device companies continue to adapt to the new regulatory environment, it is essential to assess their current compliance status and take proactive measures to address any gaps in compliance.
Verbatim Life Sciences specialises in recruiting highly skilled professionals to assist companies in meeting MDR requirements. Our extensive network includes regulatory affairs experts, consultants, and specialists who can provide tailored solutions to navigate regulatory complexities.
Our Solutions:
Regulatory Affairs: We connect companies with regulatory affairs professionals experienced in MDR compliance and UKCA requirements.
Gap Analysis Support: Our consultants can conduct comprehensive gap analyses to identify areas of non-compliance and recommend solutions.
Consulting Expertise: Whether companies require short-term assistance or long-term support, we can match them with consultants who possess the necessary expertise.
Verbatim Life Sciences understands the importance of finding the right people to meet regulatory needs. Our personalised approach ensures that companies have access to top-tier candidates who can drive compliance and navigate regulatory challenges effectively. In the face of evolving regulatory requirements, partnering with a recruitment agency like Verbatim Life Sciences can provide companies with the talent needed to achieve MDR compliance and navigate the intricacies of regulatory affairs successfully.
For more information on how we can assist with your staffing needs, please contact us.