EUROPEAN UNION

Regulatory Agency :

The European Union’s medical device market is regulated by the Medical Device Coordination Group (MDCG).

EU Medical Device Regulations & Guidance :

• Regulations on medical devices (MDR) : Governing general safety and performance of medical devices.
• Regulation on in vitro diagnostic medical devices (IVDR) : Focused on in vitro diagnostic medical devices.

EU Medical Device Classifications :

Medical devices are classified under a series of 22 rules, resulting in seven classifications:

• Class I : Lowest risk (e.g., wheelchairs, reading glasses).
• Class IIa : Medium risk (e.g., surgical clamps, dental fillings).
• Class IIb : Medium-to-high risk (e.g., ventilators, bone fixation plates).
• Class III : Highest risk (e.g., heart valves, defibrillators).
• MDCG 2021-24 - Guidance on classification of medical devices.

IVD Device Classifications :

The EU uses a series of 7 classification rules for IVDs, with four classifications:

• Class A : Lowest risk (e.g., specimen receptacles, buffer solutions).
• Class B : IVDs for self-testing with lower risk (e.g., pregnancy tests).
• Class C : IVDs used for detecting an infectious agent that does not have a high risk of propagation.
• Class D : IVDs detecting life-threatening transmissible agents.
• Annex VIII of the IVDR - Classification rules.

Medical Device Market Requirements in the EU :

• CE Mark : The CE mark is necessary for marketing devices within the EU. The process includes independent assessment by a notified body, conformance with applicable standards, and an EU declaration of conformity. Technical documentation and EU declaration of conformity.

EU Post-Market Requirements for Medical Devices :

• Post-Market Surveillance : Required to monitor device performance and collect use-data.
• Post-Market Vigilance : Manufacturers must report any serious incidents involving a marketed device. EU MDR Article 87 - Reporting of serious incidents and field safety corrective actions.

Medical Device Market Requirements in the EU :

• UDI Compliance : Delayed compliance deadlines for labeling are spread out from May 2022 through May 2027. EC Unique Device Identifier (UDI) information.

Standards and Essential Requirements in the EU :

• he European Commission has published a list of harmonized standards to meet the general safety and performance requirements. Major standards include EN ISO 13485, EN ISO 14971, and EN IEC 60601-2-83 Summary of harmonized standards in EU 2017/745.

How Medfins will help you !

At Medfins International, we are dedicated to guiding you through the complexities of the European Union's medical device market. Our experts are well-versed in EU regulations, including MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), and offer comprehensive support at every stage, from device classification to market authorization and post-market requirements.

• Tailored Regulatory Strategy: : We develop customized strategies to ensure your medical devices comply with all relevant EU regulations, aiming to minimize the risk of market entry delays in the European Union.
• Compliance and Submission Support : Our team aids in preparing and submitting essential documentation for CE marking, ensuring strict adherence to the EU's rigorous standards for both MDR and IVDR.
• Post-Market Surveillance Guidance : We offer advice on establishing effective post-market surveillance systems in compliance with EU mandates, crucial for maintaining market presence and fulfilling vigilance requirements.
• Ongoing Regulatory Support : Stay informed of regulatory changes with our continuous monitoring and advisory services, ensuring your sustained compliance with EU medical device regulations.