The European Union’s In vitro Diagnostic Regulation took full force on May 26, 2022, replacing the former In Vitro Diagnostic Medical Devices Directive (IVDD). The IVDR specifies stricter rules for certifying and marketing in vitro diagnostic (IVD) equipment in the EU. While the regulation aims to improve patient safety and diagnostic device quality, it presents significant obstacles to small and medium-sized businesses (SMEs). Compliance with IVDR can be especially difficult for SMEs due to limited resources, experience, and financial capability. This article looks at the impact of IVDR on SMEs, the issues they experience, and compliance measures, including the involvement of consultants.
Challenges Faced by SMEs
- Stringent Classification and Increased Scrutiny:
IVDR introduces a risk-based classification system, increasing the proportion of devices that require external conformity review by an estimated 80%. Many SMEs now need independent certification for products that formerly required only self-declaration, which necessitates additional documentation and technical assessment. - Documentation and Technical File Requirements
This regulation mandates significant technical information, such as detailed performance assessments, clinical evidence, and post-market surveillance plans. Preparing these documents demands extensive skill and effort, which can overwhelm SMEs without specialized regulatory teams.
- Limited Body Capacity Notified
The increase in devices that require verification has put an added burden on the limited number of notified bodies designated under IVDR. SMEs frequently find themselves in long waiting lines, which affects their access to markets and causes insecurity. - Financial Stress
IVDR compliance necessitates a large investment in clinical research, testing, and regulatory knowledge. These expenses may be unaffordable for SMEs with little resources, endangering their ability to continue operating. - Resource Constraints
Unlike large corporations, SMEs typically lack in-house regulatory teams and resources to manage the complexities of IVDR compliance. This resource gap leaves them vulnerable to non-compliance penalties and market exclusion.
To achieve IVDR compliance, SMEs need to implement several strategies:
- Start early to allow time for clinical evidence collection, technical documentation development, and addressing feedback.
- Conduct a thorough gap analysis to identify and address deficiencies.
- Leverage existing clinical and performance data to reduce costs and efforts.
- Collaborate with academic institutions, research organizations, or other SMEs to share resources and knowledge.
- Invest in regulatory and quality management employee training to develop a compliance-focused culture and employ regulatory consultants to assist you in negotiating rules, streamlining procedures, and efficiently using resources.
Role of Consultants in IVDR Compliance:
Consultants serve as a lifeline for SMEs struggling to meet IVDR requirements. Their roles include:
Technical documentation support – Preparing IVDR-compliant technical files is a rigorous procedure. Consultants help with document drafting, review, and organization to ensure compliance with notified body expectations. They check that all needed components—including performance evaluations, risk assessments, and clinical evidence—are comprehensive and correct.
Notified Body Liaison – Small and medium-sized enterprises might struggle to navigate contacts with notified bodies. Consultants are facilitators, promoting communication, handling issues, and ensuring smooth progress through the certification process.
Strategic Planning
Consultants support SMEs in prioritizing activities and allocating resources efficiently. Their strategic insights can help to avoid wasteful expenses and focus efforts on high-impact compliance actions.
Training and Mentorship
Consultants encourage SMEs by giving training sessions and coaching internal teams, allowing them to develop in-house knowledge and lessen their need for external support.
Conclusion:
The IVDR presents significant challenges for SMEs, but compliance is possible with the proper strategy and support. Early preparation, efficient resource management, and utilizing the experience of regulatory experts can help to reduce the burden of compliance. While the transition may be difficult, the higher safety and quality requirements imposed by IVDR will eventually benefit patients and strengthen trust in the medical device industry.
For SMEs, examining IVDR difficulties as an opportunity to tighten systems and improve product quality can set them up for long-term success in a highly regulated market. Consultants play an important role in this journey, bridging knowledge gaps and bringing SMEs to compliance with confidence and efficiency.
Author: Meena Kumari Malavarapu
EU MDR/IVDR Consultant.