As with assignment #1, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology
company that is looking to develop a new medical device for the treatment of atrial fibrillation, also
known as irregular/rapid heartbeat. To-date, your company only has experience with the
pharmacovigilance practice related to the development of drugs/biologics. Your device is similar to a
pacemaker in that it is an implantable electronic device that will be placed in a certain location within
the heart muscle of a patient and will be left there for several years to regulate the heartbeat.
Your company is preparing to embark on medical device trials in the United States and Spain.
Your task is to provide the following information to your colleagues in the form of an executive summary
(incorporation of figures and graphs HIGHLY encouraged):
1. Introduction (1 paragraph)
a) Provide a general introduction for your colleague to explain the purpose of this briefing
document and what types of information you plan to include and why.
2. Outline the Key Players (2-3 paragraphs)
a) Regulatory Oversight for Devices: In each of the 2 countries (US, Spain), what
regulatory bodies are tasked with providing direct oversight to:
i) Medical Device pre-market development
ii) Medical Device Pharmacovigilance – hint: In Spain, you will need to address this
on two levels: The European Commission’s role and the role of The Spanish
Agency of Medicines and Medical Devices (AEMPS)
3. FDA Medical Device Requirements (3-4 paragraphs)
a) Describe the different FDA classifications for medical devices. Be sure to clearly
outline how risk plays a role in the classification of devices and explain why your
company’s device, which is intended to regulate the heartbeat, will most likely
be classified as a Class III device.
b) Identify and outline, in your own words, the key areas under the Code of
Federal Regulations that pertain to pre-market medical device
pharmacovigilance as conducted under an Investigation Device Exemption (IDE).
i) What types of medical devices fall under this part of the code?
ii) What are the pharmacovigilance/safety relevant concepts introduced in
the code?
used to seeing with drugs/biologics?
1. What are the expedited reporting details? What events meet these criteria and what are the
timeframes?
4. European Commission Device Requirements (3-4 paragraphs)
a) Describe the different EC classifications for medical devices. In what ways are they
similar or different from those employed by the FDA? Be sure to clearly outline how risk
plays a role in the classification of devices and explain why your company’s device,
which is intended to regulate the heartbeat, will most likely be classified as a Class III
device.
b) Identify and outline, in your own words, the key areas under the EU MDR that pertain to
pre-market medical device clinical investigations:
i) What are the pharmacovigilance/safety relevant concepts introduced in the EU
MDR?
ii) What safety-related definitions are introduced that are different from what
your company is used to seeing with drugs/biologics?
timeframes, if any?
1. While Spain is an EU member state and therefore comes under the EC medical device
rules, what role with Spain’s Competent Authority, The Spanish Agency of Medicines and
Medical Devices (AEMPS), play with respect to safety reporting for the medical device while it is
undergoing clinical trials in Spain
5. Conclusion/Next Steps (1-2 paragraphs)
a) What resources will you use to help your company understand the pharmacovigilance
regulations related to clinical trials of medical devices in the US and EU?
b) Will you recommend any specific vendors to help manage safety reporting during
clinical trials of your device? Feel free to take this in a creative direction
Last week assignment attached
Expert Solution Preview
Introduction:
This executive summary aims to provide information to the colleagues regarding the regulatory oversight and clinical investigation requirements for a new medical device developed by a small biotechnology company for the treatment of atrial fibrillation. The document will cover the regulatory bodies tasked with providing oversight in the US and Spain, FDA medical device requirements, European Commission device requirements, and the respective pharmacovigilance/safety relevant concepts required during clinical investigations.
1. General Introduction:
The purpose of this briefing document is to provide an overview of the regulatory oversight and safety reporting requirements for clinical trials of a new medical device. This document includes information for the colleagues regarding the regulatory framework in the US and Spain, different device classifications, and the requirements for pre-market medical device pharmacovigilance.
2. Outline the Key Players:
Regulatory oversight for medical devices in the US is the responsibility of the Food and Drug Administration (FDA). In Spain, the European Commission plays a significant role in providing regulatory oversight along with the Spanish Agency of Medicines and Medical Devices (AEMPS) at a national level. The European Commission device requirements and their classifications are similar to those employed by the FDA.
3. FDA Medical Device Requirements:
The FDA classifies medical devices into three categories based on their risk level to patients. As the new device developed by the company is intended to regulate heartbeat, it will most likely be classified as a Class III device. The key areas under the Code of Federal Regulations that pertain to pre-market medical device pharmacovigilance as conducted under an Investigation Device Exemption (IDE) include medical devices that may pose a risk to human health and the safety of patients and users. The code introduces safety-related definitions that differ from drugs and biologics.
4. European Commission Device Requirements:
The European Commission also classifies medical devices into three categories based on their risk level. The company’s new medical device will most likely be classified as a Class III device. The key areas under the EU MDR that pertain to pre-market medical device clinical investigations introduce pharmacovigilance/safety relevant concepts that differ from drugs and biologics.
5. Role of Spanish Competent Authority:
While Spain is an EU member state and comes under the EC medical device rules, the Spanish Agency of Medicines and Medical Devices (AEMPS) plays a vital role in safety reporting for the medical device while it is undergoing clinical trials in Spain.
6. Conclusion/Next Steps:
To prepare the company for the pharmacovigilance regulations related to clinical trials of medical devices in the US and EU, the resources available from the FDA and the European Commission must be utilized. The company may also benefit from specific vendors to help manage safety reporting during clinical trials of the device.