Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲

📝 Updated guidance 𝗠𝗗𝗖𝗚 𝟮𝟬𝟮𝟬-𝟭𝟲 "𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗖𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗥𝘂𝗹𝗲𝘀 𝗳𝗼𝗿 𝗶𝗻 𝘃𝗶𝘁𝗿𝗼 𝗗𝗶𝗮𝗴𝗻𝗼𝘀𝘁𝗶𝗰 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 𝘂𝗻𝗱𝗲𝗿 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻 (𝗘𝗨) 𝟮𝟬𝟭𝟳/𝟳𝟰𝟲"

📎 The main update has been in rule 3(f) about companion diagnostics (CDx), where more examples of CDx products and products that are not considered CDx have been added.

✏️ This revision also has a flowchart to help determine whether an IVD product can be considered a CDx.

🔎 To view the guidance click here.

To provide the best experiences, we use technologies such as cookies to store and/or access information on the device. Consent to these technologies allows us to process data such as browsing behavior or unique identifiers on this site. Not consenting or withdrawing consent may negatively impact certain features and functions.

Functional Always active

Technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or solely for the purpose of carrying out the transmission of a communication over an electronic communications network.

Preferences

Technical storage or access is necessary for the legitimate purpose of storing preferences not explicitly requested by the subscriber or user.

Statistics

El almacenamiento o acceso técnico que es utilizado exclusivamente con fines estadísticos. Technical storage or access used exclusively for anonymous statistical purposes. Without a requirement, voluntary compliance by your internet service provider, or additional records from a third party, the information stored or retrieved solely for this purpose cannot be used to identify you.

Marketing

Technical storage or access is necessary to create user profiles for sending advertising or to track the user on a website or across multiple websites for similar marketing purposes.