Regulatory Challenges for Novel Implantable Devices under EU MDR

Regulatory Services

In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive (MDD) and introduced significant changes to the regulatory framework for medical devices in the EU. One of the most affected categories of devices is Class III, which includes the highest risk devices such as implantable devices, active implantable devices, and devices incorporating nanomaterials. Both Class IIb implantable and Class III devices are subject to the highest level of scrutiny and require a conformity assessment by a notified body, as well as clinical evaluation and post-market surveillance.

For novel implantable devices, such as a new orthopedic implant, the regulatory challenges are even greater, as the manufacturer must demonstrate the safety and performance of the device based on sufficient clinical data. In some cases, it may not be possible or feasible to conduct a clinical investigation for a novel device, due to ethical, practical, or scientific reasons. In such cases, the manufacturer must rely on alternative sources of clinical data, such as literature, existing data, or equivalent devices to support the clinical evaluation of the novel implant. There are, however, significant regulatory challenges and requirements for obtaining a CE mark for a novel implantable device without clinical investigation under the EU MDR.

Regulatory Challenges

One of the key changes in the EU MDR compared to the previous EU MDD is the increased emphasis on clinical evidence and the reduced reliance on equivalence claims. The main regulatory challenges for a novel implantable device without clinical investigation under the EU MDR are:

1. The manufacturer must identify an existing device that is equivalent to the novel device in terms of intended purpose, technical characteristics, and clinical conditions of use. The EU MDR sets a high bar for claiming equivalence, as the manufacturer must demonstrate that the subject device and the proposed equivalent device have the same intended purpose, the same technical and biological characteristics, and the same clinical use environment and that any differences do not affect the safety and performance of the novel device. These criteria are very strict and may be difficult to fulfill for some implants, such as those with novel materials, coatings, shapes, or technologies. The manufacturer must ensure that the proposed equivalent device has sufficient clinical data to support the clinical evaluation of the novel device. For a Class IIb or Class III implant, the proposed equivalent device must be approved under the same regulatory framework as the subject device, i.e., the EU MDR, and the equivalence assessment must be based on the most recent and relevant clinical data available. If a manufacturer cannot demonstrate sufficient levels of access to the data needed to demonstrate equivalence, then equivalence claims cannot be made for the purpose of conformity assessment.
2. The manufacturer must provide a justification for the absence of a clinical investigation, explaining why it is not possible or justified to conduct a clinical investigation for the novel device. The justification must be based on scientific, ethical, or practical considerations, and must be supported by relevant data and literature. The manufacturer also must consider the potential risks and benefits of the novel device for the patients and the users.
3. The manufacturer must conduct a clinical evaluation of the novel device based on alternative sources of clinical data, following the principles and methods outlined in Annex XIV of the EU MDR and the MEDDEV 2.7/1 rev. 4 guidance. The clinical evaluation must cover all the relevant aspects of the safety and performance of the novel device. The manufacturer must document the clinical evaluation in a clinical evaluation report (CER) and update it regularly throughout the life cycle of the device.
4. The manufacturer must establish a post-market follow-up (PMCF) plan to collect and evaluate clinical data after the device is placed on the market, following the requirements of Annex XIV of the EU MDR and the MEDDEV 2.12/2 rev. 2 guidance. The PMCF plan must define the objectives, methods, data sources, and timelines of the PMCF activities, and must address any residual risks, uncertainties, or gaps in the clinical data of the subject device.

Expert Support

Obtaining a CE mark for a novel Class IIb or Class III implant without clinical investigation under the EU MDR is a challenging and complex process, requiring the manufacturer to demonstrate the equivalence of the device to an existing device with sufficient, relevant clinical data. It’s important to recognize that having full access to the technical documentation of the proposed equivalent device is not synonymous with equivalency as the devices could still have differences in clinical, technical, or biological equivalence criteria. The manufacturer of the novel device must document their justification within the CER as to why the level of access they have obtained is sufficient, and this, as well as sufficiency of the equivalency demonstration itself, must be accepted by the Notified Body.

Our team can help; contact us today to discuss your clinical evaluation needs.