Hello and welcome to another brainstorming blog to discuss the clinical evaluation of medical devices! In our previous blog post, we discussed the cycle of clinical evaluation and how to establish one for the continuous evaluation and compliance of specific devices based on risk class.
In the current blog, we are going to discuss various routes of clinical evaluation that can be considered. Please note that we are always ready to take this off your plate and serve you with tailor-made solutions for your devices. So, feel free to contact us if you need to make a clinical evaluation report.
As per TGA, Australia: clinical evidence guidelines for medical devices, clinical data (meaning safety and performance information that is generated from the clinical use of a medical device) may be generated for either the subject device or a comparable device (including substantially equivalent devices). It includes:
- Data from clinical investigations (synonymous with trials and/or studies)
- Literature reviews
- Post-market data
- Other clinical experience data (also known as real-world data).
The sufficiency of the data will depend on the risk class of the device.
Medicines and Healthcare products Regulatory Agency (MHRA), Clinical investigations of medical devices –guidance for manufacturers suggests similar requirements as MDR for the clinical evaluation of medical devices of different risk class.
The EU MDR in Article 61 provides routes for clinical evaluation. Based on the risk class, routes for clinical evaluation can be chosen from Article 61: Clinical evaluation in MDR. Note that clinical evaluation shall provide sufficient clinical evidence to prove the safety and performance of the device. So, what are the routes available for the clinical evaluation, and more importantly how do you define the route for your device? All the answers regarding the route of clinical evaluation are provided in this blog.
As per Article 61 of MDR, the following points should be considered for deciding the route of evaluation:
- The manufacturer shall specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant General Safety and Performance Requirements
- The level of clinical evidence shall be appropriate as per the characteristics of the device and its intended purpose.
- Clinical evaluation consultation process can be opted for (a) class III implantable devices, and (b) class IIb active devices intended to administer and/or remove a medicinal product. This process shall be documented in clinical evaluation report.
ROUTE OF EQUIVALENCE:
- Clinical evaluation shall be based on critical evaluation of the clinical data by establishing equivalence as per EUMDR & MDCG 2020-5: Guidance on clinical evaluation-Equivalence.
- There is a requirement for the contract with the manufacturer of an equivalent device for the adequate exchange of data. Data of the equivalent device should be adequate to justify applicable GSPRs.
- The two manufacturers shall have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis
- The original clinical evaluation has been performed in compliance with the requirements of this Regulation, and the manufacturer of the second device provides clear evidence thereof to the notified body.
- Clinical evaluation of the equivalent device should have been performed as per the requirements of MDR. Clinical data on equivalent devices may include:
- Scientific Literature currently available Data on clinical
- Investigations Consideration of currently available alternative
- Treatment options
THE NEED FOR CLINICAL INVESTIGATIONS:
In the case of implantable devices and class III devices, clinical investigations are required to generate adequate clinical data on safety and performance. However clinical investigations are exempted in the following cases:
Modifications in the design of the already marketed device by the same manufacturer. A modified device can be proven equivalent to an already-marketed device Clinical evaluation of the non-modified marketed device is adequate to justify the safety and performance of the modified device. If the device is a legacy device and lawfully placed on the market as per MDD with sufficient clinical data Compliant with the common specifications (CS), wherever available Well-established technologies like sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips or connectors for which the clinical evaluation is based on sufficient clinical data.
ROUTE OF NON-CLINICAL DATA:
In cases where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, clinical evaluation can be based on pre-clinical data according to Article 61(10) of regulation (EU) 2017/745
Hence conformity with GSPRs can be based on non-clinical testing methods alone which will include biological evaluation and bench testing. Post Market Surveillance data (PMS) data and literature data of similar devices can be used as supportive evidence.
The route of clinical evaluation as per 61(10) is considered based on following facts:
- Manufacturer’s risk management
- Interaction between the device and the human body
- Manufacturer’s claims and clinical performance
A medical device can be clinically evaluated in different ways discussed in this blog. If you are still not sure about what should be the route of evaluation for your device, you can connect to us.
If you need assistance with generating clinical data, please explore our clinical operations services. We also offer an Annual Maintenance Contract (AMC) service, where we update your documents with new data at the required frequency to maintain compliance with regulatory requirements.
In our next blog, we will discuss clinical evidence and documentation for clinical evaluation and associated data collection methods. Until then, happy brainstorming for your device’s requirements, or feel free to outsource that task to us. We are just an email away. Thank you for your time.
