The European legislation on medical devices has undergone significant reform in recent years, resulting in two main regulations: Regulation (EU) 2017/745 (MDR) for medical devices and Regulation (EU) 2017/746 (IVDR) for in vitro diagnostic devices. These legislations replaced the old directives and aim to strengthen patient safety, harmonize the European market, and increase transparency in the evaluation and monitoring of these devices.
Regulation (EU) 2017/745 – MDR
The MDR, which came into effect in May 2017, applies to conventional medical devices, such as implants, prostheses, imaging equipment, and others. It introduces significant changes, such as new certification requirements, traceability, post-market monitoring, and stricter risk categorization. Moreover, it emphasizes clinical evaluation and increased oversight by notified bodies.
Initially, the transition to the MDR was expected to be completed by May 2020, but due to the COVID-19 pandemic, the deadline was extended to May 2021. For some devices that were compliant with previous directives, there is a transition period allowing them to remain on the market until 2024, provided they do not undergo significant modifications.
Regulation (EU) 2017/746 – IVDR
The IVDR, on the other hand, focuses on in vitro diagnostic devices, such as laboratory tests used to detect diseases. This regulation also came into effect in 2017, but had a longer transition timeline due to the complexity involved. It requires diagnostic devices to meet more rigorous performance and safety standards, introduces a new risk classification system, and demands greater regulatory oversight.
The original implementation deadline for the IVDR was May 2022, but due to logistical challenges and a lack of capacity from notified bodies to meet demand, the European Commission announced a staggered extension. For higher-risk devices, the new deadline is until May 2025, while lower-risk devices have until May 2027.
Impact of the Legislation and Challenges
These changes represent a significant transformation for the medical device industry, requiring greater technical compliance, more robust clinical evaluations, and more comprehensive post-market surveillance systems. Many companies have faced significant challenges in meeting these requirements, from adapting their processes to training teams to comply with the new standards.
Additionally, the shortage of notified bodies to carry out the compliance assessments of devices has been a major hurdle, increasing pressure on the industry and regulators to ensure deadlines are met without compromising patient safety.
The MDR and IVDR regulations reflect the European Union’s commitment to ensuring the safety and effectiveness of medical devices, increasing consumer and patient confidence. However, the transition to these new rules has been complex, and the extended implementation deadlines reflect the challenges faced by the industry and regulators. For companies in the sector, compliance with these new rules is essential not only for access to the European market but also to maintain competitiveness in an increasingly demanding global market.
Sanitary Intelligence: Specialist in Medical Devices in the European Union
Sanitary Intelligence is a company specializing in providing technical and regulatory support to companies seeking compliance with the stringent European Union regulations for medical devices under both the MDR (Regulation 2017/745) and IVDR (Regulation 2017/746). With extensive experience in the sector, Sanitary Intelligence stands out by assisting companies throughout the process of adapting to European regulatory requirements, ensuring that their products can be efficiently and safely introduced and maintained in the market.
Among the main services offered by Sanitary Intelligence are:
Regulatory Consulting: Guidance on the specific requirements of the MDR and IVDR regulations, including the preparation of technical documentation, labeling, conformity assessment, and registrations in European systems such as EUDAMED. Also about global level.
Product Certification and Approval: Support in obtaining the necessary certifications from notified bodies, including conducting internal and external audits to ensure that devices meet the new safety and performance standards.
Post-Market Monitoring: Implementation of post-market surveillance systems to ensure that devices remain safe and effective throughout their lifecycle in the market, as required by the new regulations.
Training and Capacity Building: Customized training programs for teams on the practical application of the MDR and IVDR regulations, preparing companies to face audits and ensure continuous compliance.
With a highly skilled team of specialists and extensive experience in the medical device sector, Sanitary Intelligence has become a strategic partner for companies looking to ensure compliance with European Union requirements, helping avoid delays in product market introduction and minimizing regulatory risks.
This comprehensive support simplifies the transition process and keeps companies compliant with the stringent regulatory requirements, providing security for both manufacturers and patients.
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