Paul Dunleavy, Vice President of Engineering
Cogmedix is pleased to announce new medical device engineering services that highlight DFcx™ (Design for Compliance and Excellence). This blog is the first of a two-part series discussing design for compliance. Design for excellence will be discussed in my next blog.
Process and design compliance is required in the medical device industry from the design phase through manufacturing and post-market surveillance. This is true in the United States and globally. Below, I will be focusing on product development requirements.
When developing a medical device, we need to know and understand the regulatory requirements relative to the medical application, technology, and national regulations. Not all design contract medical device manufacturers provide regulatory guidance. Our DFcx™ process takes regulatory requirements into consideration at the beginning of product development, starting with determining the medical device classification. Domestically, the United States Food and Drug Administration (FDA) has three medical device classes: Class I, II, and III. Classification is based on the medical application and the potential risk associated with your product’s technology. The higher the risk of the medical application and the product technology, the higher the classification.
If you are unsure whether your product is a medical device or don’t know how to classify your product, contact the FDA’s Division of Industry and Consumer Education (DICE) by email at DICE@fda.hhs.gov or by phone at 1 (800) 638-2041 or (301) 796-7100.
In Europe, medical device classification is defined in the Medical Device Directive, MDD 93/42/EEC. Europe has four medical device classes: Class I, IIa, IIb, and III. If your product is not captured in the MDD, then you can contact the competent authority for the country in which you wish to market. The competent authority has final ruling. For example, Germany’s competent authority is the Federal Institute for Drugs and Medical Devices, also known as “BfarM.” I’d like to add a precautionary note: Not all nations classify medical devices the same way. This may drive different requirements for different nations. Be sure your overall strategy is compliant in all of the markets you wish to enter.
The medical device classification of your product will drive the regulatory path to obtaining clearance to market and distribute domestically. The medical device class also determines the necessity of design control 21 CFR 820.30 and manufacturing cGMP requirements as determined by 21 CFR 820.
Medical devices are required to meet recognized safety standards. These standards vary slightly from nation to nation. In the United States, the FDA recognizes AAMI ANSI ES60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance. Europe’s medical device safety standard is EN60601-1. Nationally Recognized Testing Laboratories can help with testing and reporting compliance to these standards. You can find the current list of NRTLs here.
There are many requirements when developing a medical device. At Cogmedix, we are dedicated to supporting our customers through all the regulatory hurdles and providing an exceptional customer experience.