The main activities in the clinical development phase of a medical device is the undertaking of clinical assessments, i.e. clinical trials. The data and information gathered from these studies are used to demonstrate and evidence the safety and efficacy of the device’s use in a human healthcare setting — ensuring that they are as safe as possible before they are placed on the market.
For IVDs, performance studies are required to confirm the analytical or clinical performance of device.
From the design of the investigations and studies themselves, to the drafting of the CER or PER files, our team of expert MedTech consultants can support you every step of the way.
We can strategically design clinical investigations and write protocols with certification in mind — smoothing the way to bringing your medical devices or IVD to market quickly. This is particularly important in ensuring a consistent and coherent development pathway.
Our specialist team — consisting of clinicians and medical writers — can draft comprehensive protocols that can be quickly implemented, including purpose, number of subjects, and primary and secondary endpoints. Our consultants also work closely with our clinical statisticians and use their insight and knowledge gained over years of industry experience to guide on demonstrating statistical significance in clinical benefit.
From application to implementation, our MedTech professionals can assist at every stage. Particularly for drug-device combinations, we can help to draft and submit your application for Clinical Trial Authorisation (CTA) to ensure approval by supporting you with the collation of data and providing the highest quality strategic advice, and guide you through agency meetings.
Once approved, we will apply our knowledge and experience in a wide range of clinical indications to facilitate a smooth delivery of clinic trials by close collaboration with study centres and the timely collation and interpretation of clinical data.
Alternatively, if a medical device is a Well-Established Technology (WET) then clinical trials may not be required, and the clinical evaluation will consist of a review of literature and studies available on the safety and efficacy of equivalent technology to demonstrate the product is fit for certification.
Our consultants have the insight and expertise to enable them to carry out this activity to an extreme level of details, to promote the highest chance of success.
To document the results of your clinical evaluation, a Clinical Evaluation Report (CER) must be compiled, forming a vital part of the technical documentation. This document evidences that the device in question meets its intended purpose with an acceptable level of risk to users and patients.
At Woodley BioReg, our medical device specialists are well-versed in the composition of CER files, and will guide you on the creation of the file for your device, or draft it on your behalf. We are also review files that you have already created internally to ensure that all requirements are met.
Performance studies are the most important source of evidence for IVDs, apart from literature searches — required to clarify the analytical and / or clinical performance of IVDs. These studies support the product’s compliance with general safety and performance requirements.
Our specialist IVD consultants can help you to plan, develop, and carry out performance studies with the regulatory strategy in mind to ensure optimal chances of successful certification.
Similar to the CER for medical devices, every IVD must have a Performance Evaluation Report (PER), which consists of three pillars: scientific validity, analytical performance, and clinical performance. Data must be collected to address each area to evidence to the Notified Body that the device is suitable to bring to market.
Notified Bodies are under intense pressure currently and therefore will dismiss any PER file submission that does not address all the requirements. At Woodley BioReg, our consultant team specialising in IVDs can assist you in creating a comprehensive PER file that is up to the Notified Body standard — ensuring the highest chance of success in registration of your device.
