In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional system the FDA employs, classifying each device by risk class and associated panel. This leads to specific regulations for each device type. The EU s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010.
The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based system set forth in Schedule 1 of the CMDR.
The Global Harmonization Task Force (GHTF) has a guidance document on medical device risk classification that uses four classes (A, B, C, and D) based on risk level. This is a rule based system defined in the guidance document.
Why you should attend: Medical device classification is an important topic for device manufacturers. Many manufacturers market essentially the same device in multiple geographic markets. The classification rules for these markets may differ. The classifications are based on risk and, as a result, may lead to differing regulatory methods to demonstrate conformity.
The various systems can cause confusion, since many of the terms are the same, but the meaning is different in different regulatory systems. The GHTF guidance document is intended for adoption by regulatory agencies and by nations with developing regulatory programs. It will form the basis for new regulatory systems.
Understanding the various device classification systems, both similarity and differences, can help your company implement a more effective global marketing approach.
Areas Covered in the Session: - The Concepts Of Medical Device Risk
- Factors that may impact risk
- Regulatory controls keyed to risk
- Classification in the US
- Device Class
- Device Panel
- Device type regulation
- Controls
- General Controls
- Special Controls
- Pre-market Approval
- FDA Guidance documents
- Recognized consensus standards
- Classification in the EU (MDD)
- Rule based system in MDD Annex IX
- Changes after March 2010
- Device class and the EU modules
- MDD Essential Requirements (Annex I)
- Harmonized standards
- Classification in Canada
- Rule based system in CMDR Schedule 1
- Specific requirements by device class
- GHTF Guidance
- Rule based system in the classification guidance
- Linkage to the Conformity Assessment guidance
