Welcome back, everyone! We hope your medical devices are performing well and meeting the necessary approval standards. If you require assistance, remember that Alceon Medtech Consulting is here to help. We serve as the regulatory genie for all your medical device requirements.
Our previous blog post covered the importance of clinical data generation and its requirements for clinical evaluation. In today’s blog, we will delve into the concept of cyclic rotation of clinical information within the clinical evaluation process. Additionally, we will explore the interconnectedness of various elements such as Clinical Investigation, Post-Market Surveillance (PMS), Post-Market Clinical Follow-Up (PMCF), and clinical evaluation.
To fully grasp these concepts, let’s first take a step back and understand the historical changes in regulations pertaining to medical devices. In the past, when a device entered the EU market through the Medical Device Directive (MDD) or the current US FDA regulations, if it demonstrated substantial equivalence to an existing device, pre-market clinical investigations could be avoided.
However, recent updates in regulations have become increasingly stringent, requiring devices to provide their own clinical data to establish safety and effectiveness.
According to the medical device regulation (EU) 2017/745 and MEDDEV 2.7/1 revision 4, the clinical evaluation process can be defined as a systematic and well-planned procedure for continuously generating, gathering, analysing, and evaluating clinical data related to a device. The purpose is to confirm the device’s performance, safety, and clinical advantages when used as intended by the manufacturer.
Two crucial aspects to note in this definition are “continuously” and “clinical data.” Manufacturers must understand that continuous generation of clinical data for their devices is imperative.
The key is to establish a cycle for collecting clinical data since it is an ongoing process to ensure that your device consistently performs well and is safe for patients.
So, how do we establish this cycle? Let’s go back to basics to understand it better. Do you have a clinical development strategy for your product? What exactly is a clinical development plan (CDP)? The requirements for a clinical development plan (CDP) are outlined in MDCG 2020-13. Essentially, it is a strategy for collecting clinical data.
As per MDCG 2020-13, a CDP should include the following information:
- Exploratory investigations (pre-market clinical investigations)
- Pre-market clinical investigations, including first-in-man studies, feasibility studies, and pilot studies
- Pivotal clinical investigations
- Post-market clinical follow-up (PMCF) with milestones and potential acceptance criteria
If you’re manufacturer or regulatory personnel working for a manufacturer thinking, “Our device has no clinical development plan or clinical data. What should we do?” There’s no need to worry. Every device starts somewhere, and we would be thrilled to contribute to your device’s journey from having “No Clinical Data” to gathering “sufficient clinical evidence.” Let’s work together to make the world a safer place, one device at a time.
Under the EU Medical Device Regulation (EU-MDR), previously certified devices are referred to as legacy devices, and certain exemptions apply to them. However, when submitting for approval, clinical data will still be required. Don’t wait for a pileup of queries, as it will only delay the approval process.
Extending the transition from MDD to MDR is not advantageous for manufacturers. The longer you delay, the more rushed you’ll be during the submission period, increasing the chances of encountering lastminute surprises regarding hidden requirements for approval. The time to act is now.
Let’s discuss some ways to establish a cycle for the continuous clinical evaluation of your medical device. The simplest method involves the following steps:
- Determine the device’s class and risk level
- Understand the frequency of submitting a clinical evaluation report (CER) and periodic safety update reports (PSUR).
- Set the collection period for clinical data between two subsequent submissions.
- Identify the clinical aspects that define the safety and efficacy of your device. This will help develop the intended use, indications, and clinical benefits.
- Familiarize yourself with the formats available for collecting different types of clinical data for your device.
- Generate new types of clinical data in each cycle or continue followup studies in the next cycle to gather long-term data
Let’s use an example to illustrate these steps.
- Suppose your device is a class III, high-risk cardiovascular device, such as a coronary stent
- In this case, CER and PSUR would be submitted annually.
- The data collection period between two submissions is one year.
- Clinical aspects to explore could include Major Adverse Cardiac Events (MACE) rates, improvement in mean luminal diameter, improvement in TIMI flow, OCT/IVUS imaging analysis, etc. The patient population might include those with STEMI, NSTEMI, diabetes, etc.
- Various formats can be used to generate clinical data, such as clinical investigations, PMCF studies, registries, and feedback collection.
- For example, you could choose a PMCF study and plan studies on different patient groups or indications in different cycles, or continue the PMCF study with extended follow-ups in the next cycle.
Now you know how to establish a continuous cycle for collecting clinical data for your device. We hope this sheds enough light on the generation of clinical data. 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 the documentation requirements 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 a phone call away. Thank you for your time.
