MDR Postponement

The Medical Device Regulation 2017/745/EU (MDR), implemented by the European Commission on May 26, 2021, was postponed under specific conditions until May 26, 2024. This decision was published in the Official Journal of the European Union on March 20, 2023, due to reasons such as the COVID-19 pandemic, manufacturers’ lack of preparedness, and the insufficient number of notified bodies designated under the MDR.

Among these postponement conditions, the most critical requirement is that manufacturers must submit a formal application to a notified body designated under the MDR by no later than May 26, 2024. Additionally, they must sign a contract with the notified body by September 26, 2024, at the latest.

1. Definition of Medical Devices

   The MDR expands the definition of medical devices to include products previously excluded from regulation, such as software and certain aesthetic products.

   Common Specifications (Section II, Article 9)

   With the MDR, external documents previously referenced by medical device manufacturers in certification processes, such as harmonized standards and MEDDEV guidelines, now include new Common Specifications (CS) referred to as MDCG Guidelines. Medical device manufacturers must consider these CSs when ensuring MDR compliance.

   Manufacturers holding a valid CE certificate under the 93/42/EEC Medical Device Directive (MDD) are also required to implement some of these common specifications.

   MDCG → Medical Device Coordination Group
   Each member state appoints a member and an alternate, both experts in the field of medical devices, and a member and an alternate for in vitro diagnostic medical devices, for a renewable three-year term.

   The Common Specifications are published by this body to ensure effective and consistent implementation of the regulation, providing a shared understanding of how the MDR should be applied in practice.

   Relevant guidelines can be accessed through the following links:

   • European Commission Guidance Documents
   • TITCK EU Guidelines/Translated Guidance Documents

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   Clinical Investigations (Section VI, Annex XV)

   If a medical device manufacturer has no equivalent product accepted in the European market and defensible according to MDCG 2020-5 Guidelines, a Clinical Investigation must be conducted.

   Additionally, for legacy devices certified under the 93/42/EEC Medical Device Directive and already on the market, the need for clinical investigations must consider the following:

   Clinical investigations are required for implantable medical devices and Class III devices, except in the following cases:

   1. The device is designed as a modification of an already marketed device by the same manufacturer.
   2. The modified device has been demonstrated by the manufacturer to be equivalent to the marketed device under Annex II, Section 3, and this equivalence is confirmed by the Notified Body.
   3. The clinical evaluation of the marketed device is sufficient to demonstrate the safety and performance requirements of the modified device.

   In such cases, the Notified Body verifies the suitability of the Post-Market Clinical Follow-up (PMCF) plan and ensures it includes post-market studies demonstrating the safety and performance of the device.

   Clinical investigations are also not required in the following cases, as per paragraph 6:

   a) Devices legally placed on the market or put into service under Directives 90/385/EEC or 93/42/EEC and whose clinical evaluation:

   • Is based on sufficient clinical data, and
   • Complies with applicable product-specific Common Specifications (CSs), if available.

   b) Sutures, staples, dental fillings, dental brackets, crowns, screws, wedges, plates, wires, pins, clips, and connectors whose clinical evaluation:

   • Is based on sufficient clinical data, and
   • Complies with applicable product-specific CSs, if available.

   A manufacturer claiming equivalence to an already marketed device not produced by them can avoid conducting a clinical investigation if, in addition to fulfilling the requirements of paragraph 4, the following conditions are met:

   1. The two manufacturers have a valid agreement that explicitly and continuously grants the second device manufacturer full access to the technical documentation.
   2. The original clinical evaluation was conducted in compliance with the requirements of this regulation.

4. Clinical Evaluation

   Medical device manufacturers must verify the clinical benefit, clinical safety, clinical performance, and clinical risks of the medical devices they produce, in accordance with the MDCG 2020-5 and Meddev 2.7.1 guides.

   These evaluations must be based on clinical data. If these expectations cannot be met through the “Clinical Evaluation” study by providing sufficient clinical data, the manufacturer is required to conduct a more costly and long-term process called “Clinical Research” in accordance with EN ISO 14155 standards.

   One of the most significant innovations introduced by the MDR (Medical Device Regulation) relates to the equivalence process in clinical evaluations. Under the previous MDD (Medical Device Directive), manufacturers could demonstrate equivalence by proving that there was no clinically significant difference in the materials or the clinical use of a device, and use a similar device for certification purposes. However, the new MDR emphasizes that material differences might reduce equivalence, and this cannot be defended anymore.

   Medical device manufacturers must show a comparable device for their product when it is first placed on the market. They must also prove this equivalence with sufficient evidence in line with MDCG 2020-5.

   Post-Market Surveillance (PMS) (Section VII, Annex III)

   Post-market surveillance (PMS) refers to the collection of processes and activities used to monitor the safety and performance of medical devices after they are released to the market. This process must be proportional to the device’s risk class and type.

   The introduction of MDR brought significant changes to PMS processes, expanding the scope and adding critical reporting activities for manufacturers. These reports now include:

   • PMS Report
   • Periodic Safety Update Report (PSUR)
   • Safety and Clinical Performance Summary (SSCP)
   • Post-Market Clinical Follow-up (PMCF)
   • Reporting of Serious Adverse Events and Field Safety Corrective Actions
   • Trend Reporting

   This system ensures that design and/or usage issues are quickly identified, and real-world device behaviors and clinical outcomes are accurately characterized.

   Medical Device Classification (Annex VIII)

   Like the MDD, the MDR categorizes devices into seven different classes based on:

   1. Intended purpose
   2. Location and duration of use/contact
   3. Composition
   4. Effect/working mechanism

   With MDR, the number of classification rules has increased and become more detailed. For example, Class Ir (Reusable Surgical Instruments) was defined, and some products, like meshes used in hernia treatments, saw a change in class.

   For classification, manufacturers can refer to the MDCG 2021-24 Guide.

   UDI Codes (Section III, Annex VI)

   UDI-DI (Device Identifier) and UDI-PI (Production Identifier) are essential for tracking medical devices. UDI-DI is a unique code specific to a device model, used as an access key for information in the UDI database, and is generally obtained through organizations like GS1.

   UDI-PI reflects how the device was controlled and provides information, including serial numbers, batch numbers, or production dates.

   Implant Cards (Section II, Article 18)

   Implant Cards are required for implant manufacturers under MDR. The purpose of these cards is to:

   1. Enable patients to identify the implanted device and access additional information (e.g., via EUDAMED).
   2. Allow patients to be identified as requiring special treatment during safety checks.
   3. Ensure emergency personnel are informed of specific care needs during emergencies.

   EUDAMED Registration (Section III)

   To enhance transparency, the MDR introduces a new registration system for manufacturers, the EUDAMED database. Manufacturers must:

   • Register in EUDAMED within 18 months if the system is functional before the MDR application date.
   • If not, registration must occur within 24 months after the official notice that EUDAMED is functional.
   • In case of serious adverse events or corrective actions, devices in the market must be registered as soon as the reports are filed.

   Authorized Representative (Section II, Article 11)

   An Authorized Representative is required if the device manufacturer is not based within the European Union. This representative is responsible for carrying out specific obligations on behalf of the manufacturer. The authorized representative must be established within the EU and is jointly liable with the manufacturer for defective devices.

   Product Liability Insurance (Article 10, Section VI, Article 69)

   Manufacturers must ensure that they have appropriate liability insurance to cover potential damages caused by defective products. Insurance requirements vary depending on the device’s risk class, type, and the size of the business. This includes:

   • Product Liability Insurance (recommended)
   • Product Recall Insurance (recommended)
   • Clinical Research Volunteer Patient Insurance (mandatory)

   Compliance Officer (Section II, Article 15)

   Manufacturers must appoint at least one person responsible for compliance with medical device regulations. This individual must have expertise in areas such as law, medicine, pharmacy, engineering, or a related scientific discipline. This person’s duties include ensuring that devices meet quality management standards, preparing technical documentation, and fulfilling post-market surveillance requirements.

   In cases of research devices, the declaration outlined in Annex XV, Section II, Paragraph 4.1 must also be prepared.