Regulatory Open Forum

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

Based on your experience, could you please confirm or add any thought to how above?
Thank you!!

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

Based on your experience, could you please confirm or add any thought to how above?
Thank you!!

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.

The EU MDR regulation allows for advertising and promotion of non-approved products for HCPs to be shown at trade fairs and exhibitions when following these rules:

• the product shown in the trade fair must be indicated as per demonstration only and not bear the CE mark.
• Any advertising and promotional material must inform that the product is still not approved for its intended purpose. It is not available for commercialisation until the certification process is completed (art.21 b3 MDR 2017/745).

Regarding the US, I didn't find a specific rule. I am still investigating. It seems that any advertising and promotion is forbidden until a medical device is approved/listed.

In the US and EU, any advertising and promotion via WEB of a non-approved medical device is forbidden. However, until the product and the communication are addressed to professional users, investigators, and investors, it is possible to share information concerning the product development progress, including clinical investigation results, submission for the FDA/NB approval.