• Simulate the role of a Regulatory Affairs manager in identifying the key differences between pharmacovigilance practices for drugs/biologics vs. medical devices
• Demonstrate understanding of the relevant Safety Reporting guidelines for drugs and devices in the US and EU, specifically
• Apply knowledge of the relevant Safety Reporting regulations for drugs, biologics, and devices in a real-world setting

Imagine 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)
   1. 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)
   1. Regulatory Oversight for Devices: In each of the 2 countries (US, Spain), what regulatory bodies are tasked with providing direct oversight to:
      1. Medical Device pre-market development
      2. 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)
   2. FDA Medical Device Requirements (3-4 paragraphs)
      1. 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.
      2. 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).
         1. What types of medical devices fall under this part of the code?
         2. What are the pharmacovigilance/safety relevant concepts introduced in the code?

• What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?

1. What are the expedited reporting details? What events meet these criteria and what are the timeframes?

1. European Commission Device Requirements (3-4 paragraphs)
   1. 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.
   2. Identify and outline, in your own words, the key areas under the EU MDR that pertain to pre-market medical device clinical investigations:
      1. What are the pharmacovigilance/safety relevant concepts introduced in the EU MDR?
      2. What safety-related definitions are introduced that are different from what your company is used to seeing with drugs/biologics?

• What are the expedited reporting details? What events meet these criteria and what are the timeframes, if any?

1. Optional: 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

1. Conclusion/Next Steps (1-2 paragraphs)
   1. 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?
   2. 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.