Over the past 10 years, regulations in the medical devices and diagnostics industry in Europe have become increasingly complicated. The Medical Device Regulation of 2017 and the In Vitro Diagnostic Regulation of 2017 altered vendor practices not only in documentation workflow but also in how the safety of a product is monitored after it is released to market. The shift increased the amount of technical evidence required for CE marking, as well as the responsibility placed on companies to maintain the retention of Quality Management Systems (QMS) compliant with ISO 13485. Consequently, companies across Europe sought structured support to keep up with changing rules and ensure that their internal processes met the expectations of their notified bodies.
Across the European Union, regulators have reported that the volume of technical documentation submitted for assessment has increased significantly since the transition from MDD to MDR. According to data shared by the European Commission in 2023, applications for MDR certification increased significantly compared to the previous three-year period, reflecting the growing demand for regulatory approval of medical devices in the EU. This increase has created a heightened need for specialized consulting support, particularly for firms facing gaps in documentation, risk classification, or post-market surveillance planning. These challenges have also encouraged companies to adopt more mature quality management systems that meet the requirements of ISO 13485, which remains the primary international standard guiding device manufacturing practices.
Within this broader context, SIRE Life Sciences has built a consulting practice that supports medical device and diagnostics organizations as they respond to these regulatory shifts. Under the leadership of Jordy Stravers, the company has developed capabilities that address compliance readiness, quality system development, and the preparation of technical documentation required for European market access. These services reflect a broader trend in which European firms seek external regulatory expertise to strengthen internal audit procedures and documentation accuracy, especially during the transition timelines associated with MDR and IVDR.
A central area of SIRE Life Sciences’ work is supporting companies preparing for MDR readiness assessments. Many organizations have required updated conformity strategies following changes to clinical evidence provisions, device classification rules, and post-market clinical follow-up requirements. Consultants from the firm assist clients in reviewing their existing documentation, identifying gaps, and organizing the materials required for CE marking submissions. This support has become particularly relevant as data from the European Commission shows that only a limited percentage of legacy devices completed full MDR certification by early 2024, underscoring the urgency of structured compliance planning.
Technical documentation remains one of the most resource-intensive components of device regulation. Many companies have had to revise their product dossiers to include expanded sections on risk management, usability, and post-market performance. SIRE Life Sciences contributes to this process by helping firms assemble complete files that follow MDR requirements. This work includes organizing clinical evaluation reports, updating risk documentation in accordance with ISO 14971, and preparing labeling materials that comply with relevant language and content requirements. The company’s involvement reflects a broader shift within the medtech sector, where documentation completeness has become a critical determinant of regulatory timelines.
Another area of growing demand relates to ISO 13485 quality management system maturity. European regulators have reported that gaps in QMS design are among the most common reasons for delayed device approvals. To address this, SIRE Life Sciences guides on implementing quality systems and preparing for internal audits. This includes reviews of manufacturing procedures, document control systems, supplier management frameworks, and CAPA processes. These activities align with the expectations of both notified bodies and international standards organizations, and they help clients prepare for surveillance audits conducted at regular intervals.
Post-market surveillance has become increasingly crucial under MDR, which places stronger obligations on manufacturers to collect and evaluate safety data throughout a product’s lifecycle. Companies are now required to submit periodic safety update reports and trend analyses for a wide range of devices. SIRE Life Sciences assists clients in establishing monitoring systems that track field performance, incident reporting, and follow-up investigations. This work is connected to the firm’s broader regulatory consulting activities, including safety documentation updates and preparation for unannounced audits, which have become more common in Europe since 2014.
Throughout these engagements, the company’s work is shaped by regulatory expectations set by European institutions, including the European Medicines Agency and national competent authorities. The consulting work does not reference specific clients, but it reflects a range of common challenges faced by medtech organizations throughout the continent. These challenges include the need for accurate documentation, the pressure to meet regulatory timelines, and the requirement for continuous updates to quality management practices.
SIRE Life Sciences has expanded its regulatory consulting services across Europe and other countries in recent years. Under Jordy Stravers’s leadership, they have continued to work with organizations focused on device construction, diagnostics, and quality improvement programs. The consulting work put them in touch with their network of consulting firms that assist medtech companies with compliance in a heterogeneous regulatory environment across diverse jurisdictions in Europe. Participating in this activity illustrates the continuing role of a consultancy in aiding compliance and maintaining ongoing stability within a complex set of regulations.
