Present:

For SK+MED
Dr Vladimir Miceita
Jana Adamcová, MBA, MPH
Mgr. Lenka Borošová

For MZ SR:
Dr. A. Table
PharmDr. Rastislav Pullmann
RNDr. J. Slaný, CSc.
MUDr. M. Slávik (ŠÚKL)

MUDr. A. Hlôška, Director General Department of Pharmacy and Drug Policy of the Slovak Republic welcomed and started negotiation. He asked SK+MED representatives to present their requests. The representatives of SK+MED stated that they supported many aspects of the proposed changes in Proposal for an EU regulation on medical devices drawn up and presented for further legislative action, the European Commission on 26.09.2012. Representatives SK+MED stated that some of the proposed measures were seen as questionable as will lead to a much more complex approval system and create more barriers. They raised objections to some of the comments and proposals of the European Parliament of 22.10.2013 which contains a number of changes leading to improvement current system, but in some specific situations submitted proposals make the system more complex, uncertain and burdensome in some key areas.

Representatives of SK+MED submitted comments on the most important aspects of the proposal for a regulation on health tools. The opinion of RNDr. J. Slaný, CSc. participates in the proceedings of the Council Working Party on Health products and medical devices.

Reminder No. 1
Control (Strutinium called)
The representatives of SK+MED presented the problem of the approval of medical devices in Class 3, which will increase the burden on manufacturers and delay the approval process and thereby delaying the marketing of new medical devices.

The representative of the Slovak Republic stated that in general the proposal Regulation to strengthen pre-market control, i.e. to increase quality requirements the activities of the notified bodies and their appointment.

Reminder No. 2
Reprocessing (Reprocessing) single use medical devices
The representatives of SK+MED disagreed with the comments made by the European Parliament in the reprocessing area is not precisely defined criteria and is not defined responsibility for reprocessing.

The representative of MZ SR stated that in the working group the proposal is being discussed. EN joins Member States supporting Reprocessing, if a clear responsibility for reprocessing is established; and encourages the development of harmonised conformity assessment procedures medical devices after reprocessing.

Reminder No. 3
Clinical studies
The representatives of SK+MED disagreed with the European Parliament's proposal that all medical devices have been subjected to clinical trials and have justified this by This is contrary to international standards according to which clinical trials requires only to demonstrate safety and efficacy if necessary.

The representative of MZ SR stated that the scope of medical devices, which will be subject to clinical trial has not yet been agreed. There was a consensus that The principles of the clinical trial will apply mutatis mutandis to clinical trial ZP as in a clinical trial of medicinal products.

Reminder No. 4
Use of hazardous substances
SK+MED representatives support the European Commission's original proposal. They object European Parliament's request to exclude the use of all hazardous substances in medical devices.

MZ SR representative stated that the working group did not support the proposal EP to exclude all hazardous substances across the board. For some exactly defined groups ZP will be hazardous substances in justified cases tolerated. The outcome will depend on the agreement with the EP.

Reminder No 5
Health technology and device industry in Europe
Representatives of SK+MED stressed that the medical device industry is significant a source of innovation in Europe.

The representative of MZ SR concluded that the working group was still The EP's comments have not been systematically addressed because the EP will be the comments to be discussed in plenary until 2.4.2014.

The representative of MZ SR suggested that the representatives of SK+MED should prepared and sent to the Slovak Ministry of Agriculture their comments and proposals on individual articles the proposal for a regulation on medical devices.

Signed up by Mgr. Bronislava Lettuce
MZ SR Þ Department of Pharmacy

They approved: RNDr. Jozef Slaný, CSc.
Director of the Department of Pharmacy

Dr. Adam Hlôška,
Director-General of the Pharmacy and Drug Policy Section