Medical Device Regulation 2017/745/EU (MDR)
The EU created a revised regulation for medical devices, passed in May of 2017 with a 5-year transition period. This new regulation, the Medical Devices Regulation 2017/745/EU (MDR), was built to replace 3 current medical device directives: the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDMD), the Medical Devices Directive 93/42/EEC (MDD), and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR became effective on May 16, 2021, for medical devices which fall under 2017/765 and on May 26, 2022, for in vitro diagnostic medical devices which fall under 2017/756. While the MDR and its new rules strengthen controls to ensure that medical devices are safe and effective, the process of its creation is also designed to create an environment that breeds innovation and fosters competition in the medical device market.
Summary of changes under MDR:
- Stricter pre-market control.
- Clinical evaluation and investigation are reinforced and requirements for hazardous substances are introduced.
- A comprehensive database on medical devices (EU-DAMED) was created.
- A new device identification system was created. A unique device identifier (UID) will help trace medical devices.
- Patients with implanted medical devices will be given implant cards to make information on their devices easily available.
- Devices are separated into four risk classes. Financial compensation requirements created.
- A more rigorous conformity process for high-risk devices involving notified bodies.
- Specific needs of smaller manufacturers addressed.
- Minimum requirements are set for the reprocessing of single-use medical devices.
- Rules on the incorporation of nanomaterials in medical devices.
- The addition of online sale of medical devices to the scope of this regulation
Obligations as a Manufacturer
- System for risk management and quality management.
- Conduct clinical evaluations.
- Compile technical documentation.
- Apply for conformity assessment.
- System for Financial Responsibility (in case of defective devices)
- Name person responsible for regulatory compliance
- Provide Implant Card* *not applicable to all cases.
Once these are complete, you may draft a declaration of conformity and apply CE marking to the device. Note that manufacturers outside the EU must have a contract with an authorized representative inside the EU to obtain conformity and access to the EU market.
The European Commission maintains that this regulation will create a more competitive environment within the medical device industry and will solidify confidence in these devices not only within the EU but throughout the world. The regulation also takes care to address the specific needs of SMEs (small and medium sizes enterprises) so that they do not lose a competitive edge against bigger enterprises or get buried with legal uncertainty or under requirements for financial coverage.
In general, the medical device regulation strengthens rules and guidelines found in the directives it is replacing, introduces a new level of transparency when it comes to medical devices, and creates a harmonized understanding of medical device regulation throughout the EU. The MDR also has a wider scope than the directives it is replacing; covering cleaning, sterilizing, or disinfecting, reprocessed-single use devices, use of nanomaterials, devices with no intended medical purpose, and the online sale of medical devices.
Under the medical device regulation, a comprehensive database on medical devices, the EU-DAMED, was created. This database is updated with information throughout the whole lifecycle of a product. This database was not only created for transparency and the benefit of the patient/customer but also to boost innovation in the medical device field. Since medical device manufacturers will have such abundant data at their fingertips, the ideation and creation of new medical devices will surge thus creating solutions for a variety of problems.
To be added to the EU-DAMED database a system of unique identifier codes (UDIs) was created. Each medical device will have a device identifier (UDI-DI) specific to the device and a production identifier (UDI-PI) to identify the unit producing the device. Manufacturers are responsible for the entry and updating of this information in the EUDAMED database.
Under the MDR, all medical devices and in vitro diagnostic devices may fall under four risk classes. Each risk class has its own conformity assessment and in the case of medium or high-risk classes (Class IIa, IIb, and III) Notified Bodies must be involved in the conformity process. The role of Notified Bodies under MDR is to participate in joint assessments of potentially high-risk devices (Class III, and IIb). During these assessments, an independent expert may be asked to provide an opinion, but the final decision is up to the Notified Body. For certain high-risk devices, MDR may require the Notified body to consult with an expert panel before the device goes to market and although the notified body isn’t obligated to follow the opinion of the panel, they must provide a reason for contradicting it. Documents containing a detailed account of this decision and the opinion of the panel will be available to the public via EUDAMED. In addition, manufacturers’ quality management systems must now include clinical evaluation and post-marketing clinical follow-up (in that order).
This regulation also sets minimum requirements for the reprocessing of single-use medical devices. This often can be done under controlled conditions, when properly authorized, and legal on a country-by-country basis. When this transpires, the entity which wants to reuse the device assumes the same financial and legal obligation in place of the manufacturer.
The use of nanomaterials is also addressed in the Medical Device Regulation. These devices hold their own dedicated classification. One major risk factor is the possibility of nanomaterial coming in contact with the inside of the human body. When this risk is more likely the device will fall under a medium or high-risk class and be subject to a more strict and extensive conformity assessment process.
A financial mechanism was designed to ensure companies have sufficient financial coverage in terms of potential liability. This system considers the risk class of the device, the type of device, and the size of the company that has created the device.
FAQs about the MDR Transition
- How long will my current certification under the current directives be valid?
For Medical Devices:
After the end of the transition period (May 16, 2021), 3 years. Until May 26th, 2024.*
For In Vitro Diagnostic Medical Devices:
After the end of the transition period (May 16, 2022), 3 years. Until May 26th, 2025.*
*there is a set of exemptions for clinical investigations with sufficient clinical data that support their compliance with relevant specifications.
- Are there additional requirements if my device is high-risk?
High-risk devices have a stricter process for conformity than devices that fall under other risk levels. Most notably the involvement of a notified body. The role of Notified Bodies under MDR is to participate in joint assessments of potentially high-risk devices. During these assessments, an independent expert may be asked to provide an opinion, but the final decision is up to the Notified Body. For certain high-risk devices, MDR may require the Notified body to consult with an expert panel before the device goes to market. The Notified Body isn’t obligated to follow the opinion of the panel, but they must provide a reason for contradicting it. Documents containing a detailed account of this decision and the opinion of the panel will be available to the public via EUDAMED.