Medical devices

 

 

The sixth meeting of the European Council working party dedicated for the medical devices under Lithuanian Presidency

 

     The sixth meeting of the Working Party on Pharmaceutical and Medical Devices regarding the medical devices was held on the 16th of December, 2013 in Brussels. The meeting was attended by representatives of the European Union member states, the European Commission and the European Council Secretariat. It was the last working party meeting chaired by Lithuanian representatives. Lithuania was represented by Jolanta Karavackaitė – Health Care Attaché of the Republic of Lithuania, Juozas Galdikas – Director of the State Health Care Accreditation Agency under the Ministry of Health and Romanas Talalajevskis – Chief specialist of the State Health Care Accreditation Agency under the Ministry of Health.

During the meeting were continued examination of EU Commission’s proposals for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. The representatives of the EU member states discussed on the chapters VII of both proposals. 

It was the last working party meeting chaired by Lithuanian representatives. During the Lithuanian Presidency 6 meetings of the Pharmaceuticals and medical devices working party as organized by Lithuanian medical device team. Also the additionally 6 meetings of the experts were organized for the technical issues of the both proposals.

The next meeting of the Working Party dedicated to medical devices is prospective on 9th of January, 2014 in Brussels and will be chaired by Greek Presidency team representatives.

 

                                                                                

 

The fifth meeting of the European Council working party for the medical devices under Lithuanian Presidency

 

The fifth meeting of the Working Party on Pharmaceutical and Medical Devices regarding the medical devices was held on the 2nd of December, 2013 in Brussels. The meeting was attended by representatives of the European Union member states, the European Commission, the European Council Secretariat and the Council Legal Service. Lithuania was represented by: Jolanta Karavackaitė – Health Care Attaché of the Republic of Lithuania and  Romanas Talalajevskis – chief specialist of the State Health Care Accreditation Agency under the Ministry of Health of Lithuania.

During the meeting were continued examination of EU Commission’s proposals for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. The representatives of the EU member states finished the discussions on the chapters III of both proposals. 

The Presidency also organized the additional experts meeting to examine the technical issues on the 3rd of December, 2013 in Brussels. The examination of the annex VIII of the IVD medical devices proposal was finish on this meeting.

The next meeting of the Working Party dedicated to medical devices will take place on 16th of December, 2013 in Brussels.

                                                                                

 

The fourth meeting of the European Council working group for medical devices under Lithuanian Presidency

 

The fourth meeting of the Working Party on Pharmaceutical and Medical Devices regarding the medical devices was held on the 19th of November, 2013 in Brussels. The meeting was attended by representatives of the European Union member states, the European Commission, the European Council Secretariat, the Council Legal Service. Lithuania was represented by: Jolanta Karavackaitė – Health Care Attaché of the Republic of Lithuania, Romanas Talalajevskis and Saulė Dainiuvienė – chief specialists of the State Health Care Accreditation Agency under the Ministry of Health of Lithuania.

During the meeting were continued examination of EU Commission’s proposals for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. The representatives of the EU member states finished the discussions on the chapters II of both proposals. 

The Presidency also organized the additional experts meetings to examine the technical issues on the 20-22 of November in Brussels. The annexes I of the both proposals were examined on those meetings.

The next meeting of the Working Party dedicated to medical devices will take place on 2nd of December, 2013 in Brussels.

                                                                                

 

The third meeting of the European Council working group for medical devices under Lithuanian Presidency

 

The third meeting of the Working Party on Pharmaceutical and Medical Devices regarding the medical devices was held on the 17th of October, 2013 in Brussels. The meeting was attended by representatives of the European Union member states, the European Commission, the European Council Secretariat. Lithuania was represented by: Jolanta Karavackaitė – HealthCare Attaché of the Republic of Lithuania, Juozas Galdikas – director of the State Health Care Accreditation Agency under the Ministry of Health, Romanas Talalajevskis – chief specialist of the State Health Care Accreditation Agency.

During the meeting were continued examination of EU Commission’s proposals for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. The representatives of the EU member - states discussed about amendments to the Commission’s proposals on chapter II. 

The Presidency also organized the additional experts meetings to examine the technical issues of the proposals annexes on the 16th and 18th of October in Brussels.

The next meeting of the Working Party dedicated to medical devices will take place on 19th of November, 2013.

                                                                                

 

The meeting of the representatives of the Competent Authorities for the Medical Devices in Vilnius

 

Competent authority for the medical devices of Lithuania – Accreditation Agency organized 33rd meeting of the representatives of the Competent Authorities for the Medical Devices in Vilnius on 25-27th of September. In this meeting participated representatives of EU member states and candidates, as well as the representatives of EEA/EFTA states and European Commission.

The purpose of this meeting was to raise the most important medical devices regulation and legislation questions, to exchange of experience and to identify and prioritize issues regarding implementation and enforcement of the medical devices directives.

During the meeting were discussed on the effectiveness of the communication and cooperation between working groups and Competent Authorities, the progress of the discussions on the new proposed regulations in the Council working party were presented, also the questions related with the scope of the regulation of new proposed Regulations were discussed, the new Commission implementing regulation on the designating and the supervision of notified bodies were presented too. The representatives of the authorities share the experience of the market surveillance and registration of medical devices, the reports from the working groups were presented as well.

Event moments.

                                                                                

 

The European Council working group the second meeting for medical devices under Lithuanian Presidency

 

The second meeting due to medical devices of the Working Party on Pharmaceutical and Medical Devices was held on the 18th of September, 2013 in Brussels. The meeting was attended by representatives of the European Union member states, the European Commission, the European Council Secretariat and the Legal Service. Lithuania was represented by: Jolanta Karavackaitė – HealthCare Attaché of the Republic of Lithuania, Juozas Galdikas – director of State Health Care Accreditation Agency under the Ministry of Health, Giedrė Medžiaušaitė – Deputy Attaché for Health Care.

During the meeting were continued examination of EU Commission’s proposals for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. The representatives of the EU member - states discussed about amendments to the Commission’s proposals on chapter II. 

The Presidency informed that technical experts for medical devices meetings will be at 16th and 18th of October in Brussels. The next meeting of the Working Party dedicated to medical devices will take place on 17th of October, 2013.

                                                                                

 

The first meeting of the European Council Working Party on medical devices under Lithuanian Presidency

 

The first meeting of the European Council Working Party on Pharmaceuticaland Medical Devices relating medical devices was held on the 16th of July, 2013 in Brussels (Belgium). During this meeting the Lithuanian program and main objectives of its Presidency were presented.

Later the discussions on the EU Commission’s proposals for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devicesand proposal for a Regulation of the European Parliament and of the Council on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009were continued.

The meeting was attendedby the representatives of the European Union member states, the European Commission, the European Council Secretariat and Legal Service. Lithuania was represented by: Jolanta Karavackaitė - Health Care Attaché of the Republic of Lithuania, Juozas Galdikas - VASPVT director, Romanas Talalajevskis – VASPVT Chief specialist of Medical Devices Market Surveillance Division, Julius Tertelis – VASPVT Chief specialist of Medical Devices Market Surveillance Division, Vita Kašėtaitė - VASPVT Office Chief specialist.

The representatives of the EU memberstates presented a lot of comments on the Commission’s proposals which were examined during this meeting. The comments will be analyzed and summarized. The next meeting of the Working Party dedicated to medical devices will take place on 18th of September, 2013.

 

                                                                                

 

On the second half of 2013 Lithuania chairs the meetings of the European Council Working Party on Pharmaceuticals and Medical Devices. During the meetings two proposals submitted by European Commission will be discussed:

- Proposal for a Regulation of the European Parliament and of the Council on Medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 No. 14493/12

- Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices

 

Purpose of the review of current directives is to eliminate the legislative gaps and uncertainties, to strengthen supervision of notified bodies, rules of clinical evaluation, provisions on market surveillance and vigilance. New regulations should improve the system of legislative of medical devices, increase cooperation between the competent authorities for medical devices and traceability of medical devices.

 

During the Lithuanian Presidency for the European Council on 26-27 of September, Lithuania will organize 33rd meeting of Competent Authorities for Medical devices in Vilnius. Representatives of competent authorities will discuss on the essential questions related with legislative of medical devices, share the information and solutions of the problems. At the meeting will participate representatives of European Union Member States and EFTA, representatives of the European Commission and the representatives of candidate countries.

 

Day before the meeting of Competent Authorities will occurred the 8th meeting of Central Management Committee. A purpose of this meeting is to discuss the questions concerning the equal implementation of provisions of directives in all member states.

 

 

Page changed 2013-12-30

VASPVT

State Health Care Accreditation Agency

under the Ministry of Health

Jeruzalės str. 21,
LT-08420 Vilnius
Tel. (+370) 5 261 51 77,
Fax. (+370) 5 212 73 10,
E-mail: vaspvt@vaspvt.gov.lt

Budgetary institution,
Date is compiled and saved on the Register of Legal Entities,
Code 191352247

Work time:

I - IV 8:00 - 17:00
V 8:00 - 15:45
Lunch 12:00 - 12:45

Contacts

How to find us?

www.eunethta.eu www.inahta.org www.pasq.eu www.isqua.org www.htai.org www.who.int