Regulatory Open Forum

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Hi Corey, these were Directive documents so no longer applicable, as is also MEDDEV 2.12/1 Rev 8 on vigilance. You may still be able to find them somewhere buried in the internet but they have no guidance status under the MDR anymore. My book, the Enriched MDR and IVDR does discuss their usefulness under the MDR and provides links to all of them in the EU online document archive. 

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Dear Corey,
You will find them under https://health.ec.europa.eu/system/files/2022-01/md_guidance_meddevs_0.pdf
In this pdf you will find all links to the MEDDEV's and DSVG.
Hope this helps
Margit

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

In February 2023, the MDCG published MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This can be found on the EC website.

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Hi Corey,

To add along with the additional information already provided, why there is no specific MDCG guidance on vigilance quite yet is the EUDAMED module for Vigilance is not yet available.  If you look at the planning and the MDCG release these type of activities are in the works, but releasing guidance now would be premature without having the electronic system available.  The MDCG 2023-3 is an example of things being prepared for when the EUDAMED module will be available.  The current Manufacturers Incident Report (MIR) form has been already updated to align with EUDAMED fields which are expected.  However, the vigilance process of notifying the country or countries where incident occurred or products sold, i.e. following along the intent of MEDDEV 2.12, is still applicable.

In February 2023, the MDCG published MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This can be found on the EC website.

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Thank you, Richard.

Hi Corey,

To add along with the additional information already provided, why there is no specific MDCG guidance on vigilance quite yet is the EUDAMED module for Vigilance is not yet available.  If you look at the planning and the MDCG release these type of activities are in the works, but releasing guidance now would be premature without having the electronic system available.  The MDCG 2023-3 is an example of things being prepared for when the EUDAMED module will be available.  The current Manufacturers Incident Report (MIR) form has been already updated to align with EUDAMED fields which are expected.  However, the vigilance process of notifying the country or countries where incident occurred or products sold, i.e. following along the intent of MEDDEV 2.12, is still applicable.

In February 2023, the MDCG published MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This can be found on the EC website.

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Nothing wrong with still keeping Med Dev 2.12 in mind but it is scope for all MDR activities and is not applicable either for legacy devices.

2023-3 Q&A and the MDR are the only MDR specific guidance (check out the footnotes in 2023-3).

I would think the DSVG docs however could be more applicable than MedDev 2.12.

Thank you, Richard.

Hi Corey,

To add along with the additional information already provided, why there is no specific MDCG guidance on vigilance quite yet is the EUDAMED module for Vigilance is not yet available.  If you look at the planning and the MDCG release these type of activities are in the works, but releasing guidance now would be premature without having the electronic system available.  The MDCG 2023-3 is an example of things being prepared for when the EUDAMED module will be available.  The current Manufacturers Incident Report (MIR) form has been already updated to align with EUDAMED fields which are expected.  However, the vigilance process of notifying the country or countries where incident occurred or products sold, i.e. following along the intent of MEDDEV 2.12, is still applicable.

In February 2023, the MDCG published MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This can be found on the EC website.

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Morongo Valley CA
United States
------------------------------

Hi Corey

Here is one of many points in which I wish the EC responsible authorities would give a clear statement rather than the MDCG listing the point in a footnote.

MEDDEV 2.12 is no longer valid since the release of the MDR with Article 120. This statement as well as the change in reporting exemptions, I have had confirmed, with contacts within a competent authority about a year ago. 

Also this is stated in MDCG 2023-3 the first footnote.

"Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013.
Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)) and is not applicable under the MDR."

Under the MDR, there are limited exclusions for non-reporting a serious incident – in which specific conditions need to be fulfilled - in comparison under the MEDDEV 2.12, there are many exceptions listed for not reporting a serious incident.

Please remember in case of conflicting statements, the MDR as a regulation, overrules guidances. 

Maybe see you in RAPS Convergence in Montreal? Looking forward to it!

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 17-May-2023 14:21
From: Corey Jaseph
Subject: Where are the EU device specific vigilance guidance documents? (DSVGs)

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Morongo Valley CA
United States
------------------------------

But then European regulators point to the MEDDEV on clinical evidence... So confusing. But thank you for your excellent response, and I hope to make it to Montreal (not confirmed yet, but hopeful).

Hi Corey

Here is one of many points in which I wish the EC responsible authorities would give a clear statement rather than the MDCG listing the point in a footnote.

MEDDEV 2.12 is no longer valid since the release of the MDR with Article 120. This statement as well as the change in reporting exemptions, I have had confirmed, with contacts within a competent authority about a year ago. 

Also this is stated in MDCG 2023-3 the first footnote.

"Guidelines on a Medical Devices Vigilance System, MEDDEV 2/12-1 rev. 8, January 2013.
Please note that the MEDDEV 2.12/1 rev. 8, January 2013 was in operation under the Directives (Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMDD)) and is not applicable under the MDR."

Under the MDR, there are limited exclusions for non-reporting a serious incident – in which specific conditions need to be fulfilled - in comparison under the MEDDEV 2.12, there are many exceptions listed for not reporting a serious incident.

Please remember in case of conflicting statements, the MDR as a regulation, overrules guidances. 

Maybe see you in RAPS Convergence in Montreal? Looking forward to it!

Best Regards,

Stephanie 

------------------------------
Stephanie Grassmann
Founder & Managing Director of MedTechXperts Ltd
Biberstein
Switzerland

Original Message:
Sent: 17-May-2023 14:21
From: Corey Jaseph
Subject: Where are the EU device specific vigilance guidance documents? (DSVGs)

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,

------------------------------
Corey Jaseph RAC
Senior Research Analyst
Morongo Valley CA
United States
------------------------------

Hello,

Does anyone know where the EU has the DSVGs? I can find them on the MHRA page, but not the EC vigilance and market surveillance page, though the document, "Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev8" points to the Commission webpage on  the directives to find them.

Thanks,