The Role of Medical Devices Regulatory Consulting in FDA and CE Mark Success
Medical device manufacturing firms need to comply with the CE marking conformity and FDA approval to sell and market their product in the USA and European Union (EU). The companies must align with the regulatory framework of the EU or USA to satisfy the product quality standard and safety protocol. Medical device regulatory consulting services like Maven Professional Services provide the guidance and help in strategic decision-making to attain the legislation and international standards of medical devices.
Medical devices regulatory consulting for CE Marking
CE marking refers to European conformity that suggests the product’s compliance with the European requirement. The CE mark allows a medical device manufacturing firm to sell the product across the 30 countries of the European Union. The company must satisfy the guidelines of EU regulation 2017/745, which is also known as Medical Device Regulation (MDR).
EU regulation 2017/746 is the similar regulation applicable to in vitro medical devices. Approximately 31,000 in vitro medical devices fall under the EU regulation 2017/746. It provides the guidelines for placing an in vitro medical device on the market for human use. This regulation also verifies the performance of the in vitro medical device after introduction in the market.
Medical device regulatory consulting services play a vital role in understanding the CE marking guidelines on medical devices as well as in vitro medical devices so that manufacturing firms do not face any difficulty in marketing the product.
Medical device regulatory consulting for FDA approval
FDA approval means that a company has the license to sell or export medical devices in the USA. The process of getting approval takes time, and you need to follow the stringent guidelines. Consulting with professional medical device regulatory consulting services is a must for proper documentation and adherence to the FDA guidelines.
The FDA approval process depends on the classification system, such as Class I , Class II, and Class III. The class I represent has the medical devices that have the lowest risk to human life, whereas Class III has the highest risk possibilities for the human body. The manufacturer needs to know about the FDA 510(k) program, which refers to the premarket notification sent to the FDA for getting approval for the new medical device launch in the market that has similarity with the similar existing product.
Consulting with the medical device regulatory consulting services is essential for FDA approval or CE marking conformity. The expert guidance helps to design, develop, and market a medical device that follows the regulatory guidelines and follows the safety precautions.
Frequently Asked Questions
Who is the medical device regulatory consultant?
Medical device regulatory consultants provide the expertise solution for marketing a medical device in any place by obeying the regulations of the governing authority, such as the FDA (USA) or CE marking (European Union).
What is FDA 21 CFR ?
FDA CFR (Code of Federal Regulation) Title 21 is the regulatory guideline for food and drug manufacturers operating in the USA to abide by the protocols for human safety.
What is the difference between FDA and CE marking?
The FDA and CE differ in place of their application. FDA is for the regulation of medical devices in the USA, and CE Marking is for the EU.
