Ioanna Michalopoulou, Managing Partner LL.M
Angelos Georgamlis, Trainee Lawyer
The European Commission recently published a legislative proposal to amend Regulations 745/2017 on medical devices (MDR) and 746/2017 on in vitro diagnostic medical devices (IVDR).
The MDR and IVDR introduced significant changes compared to the previous Directive framework, strengthening requirements for clinical evidence, post-market surveillance, and traceability. However, their implementation has faced practical difficulties. The initiative is based on an assessment by the European Commission, which highlighted that, despite the modernized nature of the regulations, some procedures remain overly complex, costly, and inconsistently applied, affecting innovation, competitiveness, and product availability in the EU market.
The Commission’s legislative proposal does not aim at a full revision of the MDR and IVDR, but at targeted amendments to create a more effective and innovative regulatory framework. The main objectives are:
- Better proportionality of regulatory requirements and faster market access,
- Reduction of administrative and regulatory burdens for economic operators,
- Strengthening the functionality of the compliance system,
- Enhancing the predictability and efficiency of certification processes by notified bodies,
- Maintaining a high level of public health protection and patient safety.
The European Commission’s proposal sets clear directions for achieving its objectives. Its main pillars include the simplification of procedures and documentation requirements, the improvement of the evaluation and compliance system, and alignment with the EU harmonization framework. The revision aims to reduce compliance costs through simplified procedures and reduced administrative burden for manufacturers, distributors, and authorized representatives. At the same time, greater flexibility is introduced to adapt to changing market conditions, support leading innovations, and allow testing in a controlled environment (regulatory sandboxes) without full immediate compliance. Additionally, the proposal promotes the digitalisation of procedures, the provision of electronic instructions for use, and the creation of a unified regulatory framework for medical devices incorporating artificial intelligence. Overall, more efficient and predictable processes make the European sector more attractive for investment, fostering growth and strengthening the industry. The proposed revision is expected to have significant impacts on manufacturers, authorized representatives, importers, distributors, and notified bodies.
For patients and healthcare professionals, the proposal is expected to help ensure the continuous availability of safe and effective medical devices, as well as faster access to innovative solutions. Particular emphasis is placed on preventing shortages of critical products and on improved oversight through enhanced coordination between Member States, the European Commission, and the European Medicines Agency.
At a practical level, the MDR and IVDR amendments introduce clear and risk-proportionate timelines and compliance procedures. Previously, manufacturers had to prepare full technical documentation even for low-risk products, including extensive clinical studies and repetitive data, while assessments by notified bodies were unclear, without defined deadlines, with a maximum certificate validity of five years, and high administrative burden. Now, technical documentation is more proportionate, with clear evaluation timelines (30 days for application review, 120 days for Quality Management System assessment, 90 days for technical documentation review, and 15 days for final decision), reduced repetitive elements, removal of the five-year certificate limit replaced by risk-proportionate periodic reviews, and reduced involvement of notified bodies for certain product classes. In addition, mandatory cost transparency is required, including a detailed breakdown of all expenses, monitoring of the duration and costs of assessments with annual reporting starting in 2028, and a harmonised certificate renewal procedure, with notification to manufacturers at least one year before expiry and completion of the review within 60 days.
Under the proposed MDR/IVDR simplification framework, the European Commission is strengthening the institutional oversight of Notified Bodies by introducing harmonised procedures aimed at making the steps for assessment and certification of medical devices and in vitro diagnostics more predictable and transparent. Specifically, the European Commission and the Medical Device Coordination Group (MDCG) may assess the competence and compliance of Notified Bodies through the competent authorities of the Member States that designated them and, in cases of identified deficiencies, require corrective measures or even the withdrawal of their designation, thereby ensuring harmonised practices across all Member States and addressing serious deviations. At the same time, Notified Bodies are required to maintain clear and transparent appeal procedures for their decisions. This framework does not create a new channel of appeal for manufacturers, who continue to raise objections only within the Notified Body itself. However, it significantly strengthens the oversight and accountability of Notified Bodies, supporting the safety and continuous availability of medical devices and in vitro diagnostics in the EU market. The proposal also establishes mandatory EU-level procedures, including fixed maximum timelines for critical assessment steps, mandatory cost transparency, and annual reporting to monitor the duration and costs of processes, without circumventing the national competent authorities or the Notified Bodies themselves.
Furthermore, the changes introduce tools and flexibility for innovative products and emerging technologies. Until now, entry of innovative or AI-based products was complex, with unclear frameworks and limited testing opportunities, instructions for use remained mostly in paper format, and vigilance reporting had to be submitted within 15 days. Now, the European Commission’s proposal introduces controlled testing environments for emerging technologies, priority pathways for breakthrough and orphan devices, mandatory fee reductions (50% for micro enterprises, 25% for small enterprises, and 50% for orphan devices), extended timelines for vigilance reporting to 30 days, digitalization of submissions and documentation, as well as a structured dialogue framework between manufacturers and authorized representatives.
Timely adaptation of compliance strategies and technical documentation is imperative. Economic operators are urged to closely monitor the legislative process and assess potential changes that may affect existing and future products.
In conclusion, the targeted revision of the MDR and IVDR aims to create a more effective, predictable and competitive regulatory environment that fosters innovation and ensures the sustainability of the European medical devices sector, while maintaining the highest standards of public health protection.
