EC Regulatory Background
The new regulations set forth the measures necessary to ensure that any and all medical devices allowed to be imported, marketed or used within the European Union are compliant with the applicable safety and performance standards, providing the highest level of public health protection. Both MDR and IVDR additionally emphasize the importance of compliance with the relevant harmonized standards. At the same time, the use of harmonized standards is important to simplify the regulatory procedures and free movement of devices in the European Union.
It is also important to mention that the new Regulations implement certain significant changes in comparison to the Directives they replace. In particular, the MDR and IVDR provide additional requirements related to the design of medical devices, the manufacturing process, as well as labeling and documents to be provided together with the device. The scope of such changes also covers certain aspects related to the quality management system and introduce additional measures aimed at the mitigation of risks associated with the use of medical devices.
The approach applied to medical devices also provides taking into consideration the benefit/risk balance. In particular, the European Commission states that the benefits should be compared with the risks to the patient`s health associated with the use of the device. According to this approach, the medical device should not expose patients to an undue or unacceptable risk that actually exceeds the benefits from the use of the device.
Under the general rule set forth by the Regulations, the medical devices shall not expose patients to undue risks when being used for the intended purpose, and in the appropriate environment. To ensure this, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) issued the appropriate harmonized standards related to the Directives. At the same time, these standards will need an additional revision in the context of the implementation of the new Regulations.
In accordance with the document published by the EC, harmonized standards cover the requirements related to:
- The design of medical devices,
- The manufacturing process,
- Risk management,
- Quality management systems,
- Clinical investigations,
- Performance studies,
- Clinical evaluation and clinical evidence.
Under the Regulations, the information should be provided in the form of special symbols. To avoid any doubts or misunderstandings, all symbols used should be internationally recognized, and their description should be publicly available. It is also important to mention, that such symbols could not be subject to copyright protection.
Harmonized Standards` Development Process
The EC also describes in detail the whole process of the development of the harmonized standards. In particular, it will include the following steps:
- Both standardization Committees (CEN and Cenelec) shall develop a draft roadmap (work program) covering all the standards to be created.
- The Committees shall provide the EC with the aforementioned draft within the timeframe indicated in the document – by June 30, 2020. They shall also duly notify the EC about any changes made to the program.
- The Committees shall make the global project plan available to the EC.
- Reporting should be performed by both Committees on an annual basis, providing that the first annual report should be submitted by May 19, 2021.
- The final report should be submitted by June 30, 2024.
The aforementioned Committees have already confirmed that the procedures related to the adoption of the new harmonized standards, as well as rigorous review and modification of existing ones, fall within the scope of their competence. The EC also stated that in case if the additional time would be reasonably needed for the Committees to carry out all procedures described hereabove, the terms could be extended upon motivated request filed by any of the Committees.
Another important point relates to the validity of standardization mandates granted by the EC. The European Commission states that due to the fact that the Directives would be replaced by the new Regulations, the appropriate mandates related to the Directives would be no longer valid.
According to the decision issued by the European Commission, harmonized standards should include detailed technical specifications compliant with the requirements set forth by the new Regulations (both MDR and IVDR), mandatory for all parties involved in operations with medical devices. Each standard should refer to the particular requirements provided under the Regulations.
Harmonized Standards Subject to Review
The European Commission also published a list of harmonized standards that should be reviewed by the Committees in the context of the actual implementation of the MDR and IVDR. These harmonized standards should cover the most important aspects related to medical devices.
The list of harmonized standards subject to review are covering, inter alia, the following spheres:
- Sterilization of medical devices – Requirements for medical devices to be designated “STERILE”.
- Biological evaluation of medical devices.
- Sterilization of health-care products.
- Packaging for terminally sterilized medical devices.
- Aseptic processing of health care products.
- Medical devices – quality management systems.
- Clinical investigation of medical devices for human subjects.
- Non-active surgical implants.
- Medical devices – application of risk management to medical devices.
- Medical devices – symbols to be used with medical device labels, labeling, and information to be supplied.
- Medical devices utilizing animal tissues and their derivatives.
- Medical electrical equipment.
- Medical device software – Software life-cycle process.
- Medical devices – Application of usability engineering to medical devices.
The scope of harmonized standards related to the in vitro diagnostic medical devices, that are subject to revision, covers the following aspects:
- Elimination or reduction of risk of infection related to in vitro diagnostic reagents.
- Sampling procedures used for acceptance testing of in vitro diagnostic medical devices.
- Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures.
- Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials, and human samples.
Summarizing the information provided here above, the European Commission requested the European Committee for Standardization, and the European Committee for Electrotechnical Standardization to review existing harmonized standards related to medical devices (including in vitro diagnostic devices), and also to develop new standards in accordance with the requirements set forth by the new regulations – the Medical Devices Regulation 2017/745 and the In Vitro Diagnostic Medical Devices Regulation 2017/746.
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