Kiri

Dear Colleagues,

In this letter we set out our general comments on the three templates.

Regarding the document "Proposed steps/ways for the assignment of the products", we have the same question as our Italian colleagues:  if several devices of the same operator have non-conformities and the assessment has been performed by several CAs, who will request compliance?

In the same way, we agree with our Spanish colleagues who comment on the sales volume criteria, it would be very time-consuming.

We have no comments on the document “ Final report” template and „ Template letter to MF with non conformities“.

Please find attached our completed „ Criteria evaluation risk_Marjer Surveillance Campaign_EE“

Many thanks for the work you have done.

Kind regards,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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Dear colleagues

I hope this email finds you well.

Please find attached the meeting agenda of our next online meeting, which will take place on October, 30^th . In this meeting we will reach an agreement on the three documents: “create a template for non-conformities/deficiencies”, “Preparation of a template to assign products among the participants” and “Create a template for the final reports”. In this way, we will finish the first part of our WP7 “T7.1.Campaign preparation”. Please, review the documents and if you have any comment, send them as soon as possible, so it is easier to cover all the comments during the meeting.

As you will see in the agenda, during this meeting, we will also start the second task of the WP7, “T7.2 Pilot campaign”. We will reach an agreement on the MD and IVD to be included in the campaign during the meeting. For this purpose please find attached the “Criteria for the selection of the products” so all of the group can contribute with their proposal devices to be included. We kindly ask you to fill out the document and send us back your proposals for MD and IVD before October 22^th . We will be collecting everyone’s input to share and review with all of you during the meeting, with the goal of reaching an agreement on the medical device and the in vitro device to be included in the pilot campaign.

If you have any doubt, please do not hesitate on contacting us

See you soon,

The Spanish Team

Ana Domingo Hernández

Técnico en control de mercado / Market surveillance technician

Área de Control de Mercado de Productos Sanitarios / Medical Devices Market Surveillance Area

Departamento de Productos Sanitarios / Medical Devices Department

______________________________________________

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)

(+34) 665.105.107

Calle Campezo 1 · Edificio 8 · E-28022 Madrid · España

www.aemps.gob.es

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