View Larger Image Team-NB press release on 2017 sector survey has been sent to stakeholders Please click here to download it By Cindy| 2018-06-29T11:19:11+00:00 May 7th, 2018|news|0 Comments Share This Story, Choose Your Platform! FacebookTwitterLinkedinRedditGoogle+TumblrPinterestVkEmail About the Author: Cindy Related Posts Team-NB Academy is going on with training proposed to NBs only, the next training is on March 30th on “risk management” Team-NB Academy is going on with training proposed to NBs only, the next training is on March 30th on “risk management” March 2nd, 2021 It appears that there are differences in the approach between National Competent Authorities concerning the implementation the Commission Notice 2021/C 8/01 on remote audits under the Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). Therefore, at this time, Team-NB is unfortunately unable to finalise and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies. The application of remote audits under MDR and IVDR due to pandemic-related contact and travel restrictions may currently vary across Member States depending on the governance provided by authorities. It appears that there are differences in the approach between National Competent Authorities concerning the implementation the Commission Notice 2021/C 8/01 on remote audits under the Regulations (EU) 2017/745 and 2017/746 (MDR and IVDR). Therefore, at this time, Team-NB is unfortunately unable to finalise and publish its aligned position on the uniform implementation of such remote audits by Notified Bodies. The application of remote audits under MDR and IVDR due to pandemic-related contact and travel restrictions may currently vary across Member States depending on the governance provided by authorities. February 25th, 2021 The collection of datas for the Team-NB annual sector survey has been launched. The survey analyse is expected by end of March. The collection of datas for the Team-NB annual sector survey has been launched. The survey analyse is expected by end of March. February 9th, 2021 Team-NB have shared their Position Paper on remote audits with the Commission and Designating Authorities. The authorities have communicated that they are working together on different levels (national, European) in order to achieve a Union-wide harmonised implementation of the Commission Notice 2021/C 8/01. The Team-NB paper is currently on hold as the authorities work to publish a harmonised approach. Team-NB have shared their Position Paper on remote audits with the Commission and Designating Authorities. The authorities have communicated that they are working together on different levels (national, European) in order to achieve a Union-wide harmonised implementation of the Commission Notice 2021/C 8/01. The Team-NB paper is currently on hold as the authorities work to publish a harmonised approach. February 3rd, 2021 In the framework of the Notified Bodies position paper on the Commission Notice 2021/C 8/01, the task force is working to develop a list of criteria to decide whether a remote audit is justified. The document will be presented again to the Commission. In the framework of the Notified Bodies position paper on the Commission Notice 2021/C 8/01, the task force is working to develop a list of criteria to decide whether a remote audit is justified. The document will be presented again to the Commission. January 20th, 2021 EU Commission published an informative notice on the application of 2017/745 and 2017/746 regulations with regard to notified bodies audits performed in the context of quality management system assessment. EU Commission published an informative notice on the application of 2017/745 and 2017/746 regulations with regard to notified bodies audits performed in the context of quality management system assessment. January 11th, 2021 Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745. Team-NB members adopted a Position Paper for the interpretation of device related changes in relation to a Notified Body Opinion as required under Article117 of Medical Device Regulation (EU)2017/745. December 21st, 2020 Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn. Team-NB members adopted a Position paper on Directives expiring certificates – impacts and suggested solutions following a survey among NBs which took place in the automn. December 16th, 2020 The MDCG published a new guidance as MDCG 2020-17related to “Questions and Answers related to MDCG 2020-4”. The MDCG published a new guidance as MDCG 2020-17related to “Questions and Answers related to MDCG 2020-4”. December 2nd, 2020 The Commission makes available a general forecast of upcoming meetings of MDCG and subgroups for 2021 The Commission makes available a general forecast of upcoming meetings of MDCG and subgroups for 2021 December 2nd, 2020 Team-NB adopted a Position Paper prepared by the Mirror IVD WG on Team-NB consideration paper on IVDR Date of Application Team-NB adopted a Position Paper prepared by the Mirror IVD WG on Team-NB consideration paper on IVDR Date of Application November 28th, 2020 Team-NB committee adopted a Position Paper on remote auditing experience following the results of a survey addressed to all Medical Devices Notified Bodies Team-NB committee adopted a Position Paper on remote auditing experience following the results of a survey addressed to all Medical Devices Notified Bodies November 19th, 2020 Team-NB welcomed a 26th member, namely CE Certiso Kft. – Hungary, (Notified Body 2409) Team-NB welcomed a 26th member, namely CE Certiso Kft. – Hungary, (Notified Body 2409) November 6th, 2020 37 NBs answered to a survey doing their remote audit experience 37 NBs answered to a survey doing their remote audit experience November 3rd, 2020 The EU granted CORE-MD project with ESC as sponsor and Team-NB as one of the partner. The EU granted CORE-MD project with ESC as sponsor and Team-NB as one of the partner. October 23rd, 2020 Extraordinary General Assembly of the association will take place remotely. Extraordinary General Assembly of the association will take place remotely. August 27th, 2020 Team-NB participates to the AVICENNA DAY through a speech and several attendance of members Team-NB participates to the AVICENNA DAY through a speech and several attendance of members August 27th, 2020 Self-tests for coronavirus, an article from Politico Self-tests for coronavirus, an article from Politico August 26th, 2020 Team-NB welcomed a 25th member, namely AEMPS – Spain, (Notified Body 0318) Team-NB welcomed a 25th member, namely AEMPS – Spain, (Notified Body 0318) August 14th, 2020 Team-NB Academy : a new training on risk management is forecasted at the end of the year Team-NB Academy : a new training on risk management is forecasted at the end of the year July 31st, 2020 Team-NB approved a new Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical DeviceQuality Management System Regulation and ISO 13485 Audit Reports (TCP III) thanks to the preparation of the TCP task force members. Team-NB approved a new Position Paper on the requirements for the EU MDR/IVDR Notified Body Partners under the Technical Cooperation Program on Exchange of Medical DeviceQuality Management System Regulation and ISO 13485 Audit Reports (TCP III) thanks to the preparation of the TCP task force members. July 27th, 2020 Team- NB Academy : already 32 registrations for the 1 day training planned on September 29th & 30th on Technical Documentation. Team- NB Academy : already 32 registrations for the 1 day training planned on September 29th & 30th on Technical Documentation. July 22nd, 2020 Team-NB welcomed a 24th member, namely NEOEMKI – Hungary (Notified Body 1011) Team-NB welcomed a 24th member, namely NEOEMKI – Hungary (Notified Body 1011) June 23rd, 2020 List of COVID-19 essential Medical Devices (MDs and IVDs) available from now List of COVID-19 essential Medical Devices (MDs and IVDs) available from now June 8th, 2020 This rolling plan regarding the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746… This rolling plan regarding the implementation of Regulation (EU) 2017/745 and Regulation (EU) 2017/746… June 8th, 2020 Team-NB applied to the CORE-MD project as a consortium partner. Team-NB applied to the CORE-MD project as a consortium partner. June 4th, 2020 Commission published an update of the planning of MDCG meetings in 2020, due to the Covid-19 crisis. Commission published an update of the planning of MDCG meetings in 2020, due to the Covid-19 crisis. May 27th, 2020 Team-NB members have means to help you to check the validity of the certificates; please find them in the linked document. Team-NB members have means to help you to check the validity of the certificates; please find them in the linked document. May 14th, 2020 Team-NB annual sector survey is available as a graphical presentation through the link https://www.team-nb.org/team-nb-documents/ Team-NB annual sector survey is available as a graphical presentation through the link https://www.team-nb.org/team-nb-documents/ May 6th, 2020 Team-NB published a press release to present the headlines of the annual sector survey. Team-NB published a press release to present the headlines of the annual sector survey. May 5th, 2020 Team-NB wrote a statement on Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions Team-NB wrote a statement on Regulation (EU) 2020/561 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions April 29th, 2020 Team-NB approved a new Position Paper Team-NB approved a new Position Paper April 6th, 2020 During the association’s assembly, a new committee was elected. During the association’s assembly, a new committee was elected. April 2nd, 2020 Publication of a statement on COVID-19 Publication of a statement on COVID-19 March 12th, 2020 Team-NB members approved a Position Paper on Dental Implants Team-NB members approved a Position Paper on Dental Implants March 11th, 2020 62nd NB-Med meeting is planned on April 1st and 2nd in Brussels. 62nd NB-Med meeting is planned on April 1st and 2nd in Brussels. February 18th, 2020 General Assembly of the association will take place at the Hotel Martin’s Brussels EU. General Assembly of the association will take place at the Hotel Martin’s Brussels EU. February 18th, 2020 From February 1st 2020, the Withdrawal Agreement provides for a transition period until 31 December 2020 during which Union law continues to apply to and in the UK. From February 1st 2020, the Withdrawal Agreement provides for a transition period until 31 December 2020 during which Union law continues to apply to and in the UK. January 30th, 2020 European Commission makes a call for Medical Device Experts on Specific Topics European Commission makes a call for Medical Device Experts on Specific Topics January 13th, 2020 The Joint Action on Market Surveillance group held a conference opened to all stakeholders with the aim to present to the audience the key deliverables and outputs of the Joint Action. The Joint Action on Market Surveillance group held a conference opened to all stakeholders with the aim to present to the audience the key deliverables and outputs of the Joint Action. December 12th, 2019 Euromcontact invited Team-NB to speak at their Regulatory Affairs group meeting to cover items such as designations of notified bodies, difficulty of small businesses in finding a notified body, interpretation of Rule 21, Annex XVI and questions on labelling Euromcontact invited Team-NB to speak at their Regulatory Affairs group meeting to cover items such as designations of notified bodies, difficulty of small businesses in finding a notified body, interpretation of Rule 21, Annex XVI and questions on labelling December 9th, 2019 MRA with Switzerland. As long as the agreement is not signed, the MDR/IVDR Notified bodies must request an authorized representative for Swiss Manufacturers when applying for the MDR/IVDR. MRA with Switzerland. As long as the agreement is not signed, the MDR/IVDR Notified bodies must request an authorized representative for Swiss Manufacturers when applying for the MDR/IVDR. December 5th, 2019 Call for Experts on Medical Devices and In-vitro Diagnostic Medical Devices – EXTENDED Call for Experts on Medical Devices and In-vitro Diagnostic Medical Devices – EXTENDED November 12th, 2019 New member New member October 17th, 2019 Extraordinary General Assembly of the association will take place in Brussels, at the Bedford Hotel & Congress Centre Extraordinary General Assembly of the association will take place in Brussels, at the Bedford Hotel & Congress Centre September 26th, 2019 European Commission published a call for expression of interests to appoint experts to scientific panels. European Commission published a call for expression of interests to appoint experts to scientific panels. September 26th, 2019 Notified Body representatives, namely Corinne Delorme, Suzanne Halliday, Hans-Heiner Junker and Françoise Schlemmer, attended the MDCG meeting and made a presentation on important topics linked to the MDR implementation. Notified Body representatives, namely Corinne Delorme, Suzanne Halliday, Hans-Heiner Junker and Françoise Schlemmer, attended the MDCG meeting and made a presentation on important topics linked to the MDR implementation. September 25th, 2019 MedTech Dive published an article from Dana Elfin entitled “EU changes for IVDs called a ‘sea change,’ revolutionary”. MedTech Dive published an article from Dana Elfin entitled “EU changes for IVDs called a ‘sea change,’ revolutionary”. September 25th, 2019 Team-NB organised trainings on MDR clinical requirements Team-NB organised trainings on MDR clinical requirements September 12th, 2019 COMMISSION IMPLEMENTING DECISION (EU) 2019/1396 published at the Official Journal as regards the designation of expert panels in the field of medical devices COMMISSION IMPLEMENTING DECISION (EU) 2019/1396 published at the Official Journal as regards the designation of expert panels in the field of medical devices September 12th, 2019 Team-NB is invited as speaker at the 4th EAAR Annual Conference on New Medical Device Regulations. Team-NB is invited as speaker at the 4th EAAR Annual Conference on New Medical Device Regulations. August 1st, 2019 Designation process : one additional Team-NB members notified body designated against MDR Designation process : one additional Team-NB members notified body designated against MDR July 30th, 2019 Medtech Insight published an article from Amanda Maxwell entitled “30% Boost In EU MDD Certificate Renewals – And NB Staffing Levels Up 24% In 2018” Medtech Insight published an article from Amanda Maxwell entitled “30% Boost In EU MDD Certificate Renewals – And NB Staffing Levels Up 24% In 2018” June 13th, 2019 Hans-Heiner Junker and Françoise Schlemmer spoke at the 2nd EuNetHTA workshop in Vienna Hans-Heiner Junker and Françoise Schlemmer spoke at the 2nd EuNetHTA workshop in Vienna May 28th, 2019 Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued. Team-NB published a press release regarding the survey run among its members to analyse the certificates being issued. May 24th, 2019 Team-NB actively participate in NB-Med meeting which is being held on April 2nd and 3rd. Team-NB actively participate in NB-Med meeting which is being held on April 2nd and 3rd. April 3rd, 2019 Team-NB General Assembly meeting is taking place in Brussels. More than 90% of the members are present or represented. Team-NB General Assembly meeting is taking place in Brussels. More than 90% of the members are present or represented. April 3rd, 2019 Team-NB attends the NBRG meeting. The main agenda item was the change of framework as NB-Med will become NBCG under MDR/IVDR Team-NB attends the NBRG meeting. The main agenda item was the change of framework as NB-Med will become NBCG under MDR/IVDR April 3rd, 2019 AESGP Conference AESGP Conference March 26th, 2019 The Corrigendum has been published. The Corrigendum has been published. March 19th, 2019 Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs. Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs. March 4th, 2019 Team-NB, beside NB-Med, invited to attend and make a presentation at the MDCG meeting Team-NB, beside NB-Med, invited to attend and make a presentation at the MDCG meeting February 14th, 2019 The Commission published a “QUESTIONS AND ANSWERS RELATED TO THE UNITED KINGDOM’S WITHDRAWAL FROM THE EUROPEAN UNION WITH REGARD TO INDUSTRIAL PRODUCTS » with among others medical devices. The Commission published a “QUESTIONS AND ANSWERS RELATED TO THE UNITED KINGDOM’S WITHDRAWAL FROM THE EUROPEAN UNION WITH REGARD TO INDUSTRIAL PRODUCTS » with among others medical devices. February 12th, 2019 Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation. Team-NB publishes a press release regarding the designation process in the framework of the IVDR regulation. January 17th, 2019 Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are. Team-NB is publishing a survey on the MDR designation process present stages in which Team-NB notified bodies member are. December 19th, 2018 NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” NB-Med and Team-NB have jointly edited a white paper entitled “White Paper – One Year of Application” December 14th, 2018 Team-NB gave a presentation on the notified bodies views on the new regulations implementation Team-NB gave a presentation on the notified bodies views on the new regulations implementation December 5th, 2018 Team-NB publishes a statement to emphasize that Notified bodies members work within a strict regulatory framework and put patient safety at the heart of their decision making … Team-NB publishes a statement to emphasize that Notified bodies members work within a strict regulatory framework and put patient safety at the heart of their decision making … November 26th, 2018 The Commission published 3 new factsheets targeted at : The Commission published 3 new factsheets targeted at : November 22nd, 2018 A launch meeting concerning the Team-NB-MDCG mirror working groups took place in Brussels A launch meeting concerning the Team-NB-MDCG mirror working groups took place in Brussels October 22nd, 2018 Extraordinary General Assembly of the association took place in Brussels, at the NH EU Berlaymont Hotel Extraordinary General Assembly of the association took place in Brussels, at the NH EU Berlaymont Hotel October 17th, 2018 59th NB-Med meeting is planned on 16 and 17th October in Brussels. 59th NB-Med meeting is planned on 16 and 17th October in Brussels. October 17th, 2018 Team-NB attended the NBRG meeting which took place in Brussels Team-NB attended the NBRG meeting which took place in Brussels October 17th, 2018 Documents related to the new regulations are available Documents related to the new regulations are available October 8th, 2018 Further analyze of the responses of the July CIRCABC survey on the capacities of notified bodies : both the staff resource and certificates issued. Further analyze of the responses of the July CIRCABC survey on the capacities of notified bodies : both the staff resource and certificates issued. August 21st, 2018 Factsheets for manufacturers are available on the Commission website under the title “Information for manufacturers”: Factsheets for manufacturers are available on the Commission website under the title “Information for manufacturers”: August 1st, 2018 Analyse of the survey results launch on mid-June on CIRCABC related to transparency on designation process. Analyse of the survey results launch on mid-June on CIRCABC related to transparency on designation process. July 20th, 2018 Team-NB was invited to present the views of notified bodies to an EMA awareness session Team-NB was invited to present the views of notified bodies to an EMA awareness session June 28th, 2018 Team-NB director and 10 NBs members attended the COCIR seminar on Medical Device Software Team-NB director and 10 NBs members attended the COCIR seminar on Medical Device Software June 11th, 2018 Team-NB has 2 representatives attending the 1st Workshop of the EUnetHTA Task Force on HTA and Medical Device Regulation Team-NB has 2 representatives attending the 1st Workshop of the EUnetHTA Task Force on HTA and Medical Device Regulation May 31st, 2018 Registration of TEAM NB in the EMA stakeholders database Registration of TEAM NB in the EMA stakeholders database May 30th, 2018 JAMS publishes stakeholder leaflets JAMS publishes stakeholder leaflets May 23rd, 2018 Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies” Team-NB position paper on “Points to add to contracts between Manufacturers and notified bodies” May 16th, 2018 Article from Amanda Maxwell in Medtech Insight Article from Amanda Maxwell in Medtech Insight May 8th, 2018 Team-NB sector survey is available on our website Team-NB sector survey is available on our website May 2nd, 2018 During an information meeting on the new European regulation on medical devices organized by the French competent authority – ANSM, the management reports on the survey carried out by Team-NB During an information meeting on the new European regulation on medical devices organized by the French competent authority – ANSM, the management reports on the survey carried out by Team-NB April 13th, 2018 Team-NB participates at the roundtable on standard and guidelines for safety mechanisms in the Medical Devices Regulation and Sharps Directive to improve healthcare worker, patient and user safety under the aegis of Rory Palmer, MEP. Team-NB participates at the roundtable on standard and guidelines for safety mechanisms in the Medical Devices Regulation and Sharps Directive to improve healthcare worker, patient and user safety under the aegis of Rory Palmer, MEP. March 28th, 2018 Team-NB participated at the Advisory board meeting, Joint Action on market surveillance of medical devices Team-NB participated at the Advisory board meeting, Joint Action on market surveillance of medical devices March 19th, 2018 Team-NB represented at the 1st MDCG meeting open to stakeholders Team-NB represented at the 1st MDCG meeting open to stakeholders March 6th, 2018 Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD. Survey on applications by the Team-NB member notified bodies under the MDR/IVDR and how this compares with their current scope under the three current directives AIMDD/MDD/IVDD. February 15th, 2018 Team-NB participates at the international workshop on global use and application UDI. Team-NB participates at the international workshop on global use and application UDI. February 12th, 2018 MedTech forum : Team-NB members answered the questions of the audience in the session: “What’s happening with Notified Bodies?”. MedTech forum : Team-NB members answered the questions of the audience in the session: “What’s happening with Notified Bodies?”. January 25th, 2018 The CAMD (Competent Authorities for Medical Devices) published on their web site 2 documents related to FAQs to the transitional provisions of MDR and IVDR. The CAMD (Competent Authorities for Medical Devices) published on their web site 2 documents related to FAQs to the transitional provisions of MDR and IVDR. January 24th, 2018 Article in Politico by Sarah Wheaton Article in Politico by Sarah Wheaton November 29th, 2017 New member New member November 14th, 2017 Team-NB has collected information from members about their re-application. Team-NB has collected information from members about their re-application. November 8th, 2017 57th NB-Med meeting is planned on 10 and 11th October in Brussels. 57th NB-Med meeting is planned on 10 and 11th October in Brussels. September 5th, 2017 Extraordinary General Assembly of the association will take place in Brussels, at the NH Collection Grand Sablon. Extraordinary General Assembly of the association will take place in Brussels, at the NH Collection Grand Sablon. September 5th, 2017 Article from Amanda Maxwell : A majority of notified bodies members of Team-NB, will submit their application to be designated following the new regulations, still at the end of 2017. Article from Amanda Maxwell : A majority of notified bodies members of Team-NB, will submit their application to be designated following the new regulations, still at the end of 2017. September 4th, 2017 Politico Article : Medical devices regulations need action to begin relay race Politico Article : Medical devices regulations need action to begin relay race September 4th, 2017 Françoise Schlemmer attended a conference on notified bodies views on the MDR at the MEDPHARMPLAST workshop Françoise Schlemmer attended a conference on notified bodies views on the MDR at the MEDPHARMPLAST workshop August 29th, 2017 New regulations , phase 2 interpretation working groups meeting in Frankfurt New regulations , phase 2 interpretation working groups meeting in Frankfurt May 16th, 2017 Françoise Schlemmer will be involved in training on the regulatory aspects of medical devices and more specifically on the impacts of the new European regulation. Françoise Schlemmer will be involved in training on the regulatory aspects of medical devices and more specifically on the impacts of the new European regulation. May 8th, 2017 For the 7th time, Team-NB has run a survey among its members to analyse the certificates being issued, trying to differentiate between various directives and types of certificates. For the 7th time, Team-NB has run a survey among its members to analyse the certificates being issued, trying to differentiate between various directives and types of certificates. May 3rd, 2017 NBs attendance to NB-Med meetings NBs attendance to NB-Med meetings April 25th, 2017 56th NB-Med meeting will take place on 11 and 12th April. 56th NB-Med meeting will take place on 11 and 12th April. February 27th, 2017 General Assembly of the association will take place at the NH Collection Grand Sablon on April 11th 2017. General Assembly of the association will take place at the NH Collection Grand Sablon on April 11th 2017. February 27th, 2017 European Parliament adopts formally the two texts MDR and IVD European Parliament adopts formally the two texts MDR and IVD February 27th, 2017 ENVI committee tabled a recommendation for debate and vote in plenary session of the European Parliament. ENVI committee tabled a recommendation for debate and vote in plenary session of the European Parliament. February 26th, 2017 NB-MED Chair and vice-president Hans-Heiner Junker attended the Meeting of the Regulatory Affairs Committee meeting of Medtech Europe. NB-MED Chair and vice-president Hans-Heiner Junker attended the Meeting of the Regulatory Affairs Committee meeting of Medtech Europe. February 26th, 2017 Vice-president Hans-Heiner Junker attended a seminar organized by EUROMCONTACT for their members. Vice-president Hans-Heiner Junker attended a seminar organized by EUROMCONTACT for their members. February 26th, 2017 Françoise Schlemmer will make a presentation in the Afipa meeting which will take place in Paris Françoise Schlemmer will make a presentation in the Afipa meeting which will take place in Paris February 25th, 2017 Article in Medtech Insight by Amanda Maxwell : EU Notified Bodies Prepare For En Masse Redesignation Article in Medtech Insight by Amanda Maxwell : EU Notified Bodies Prepare For En Masse Redesignation February 22nd, 2017 MedpharmPlast Europe GA MedpharmPlast Europe GA November 30th, 2016 Beginning of the 2nd phase of the work concerning the interpretation of MDR requirements with the members of the MDR Working Group in Brussels. Beginning of the 2nd phase of the work concerning the interpretation of MDR requirements with the members of the MDR Working Group in Brussels. October 18th, 2016 General assembly meeting General assembly meeting October 13th, 2016 In the framework of the new Medical Device Regulations, In the framework of the new Medical Device Regulations, July 18th, 2016 New press release New press release July 8th, 2016 ENVI Committee of the European Parliament confirmed agreement on medical device and IVD regulations. ENVI Committee of the European Parliament confirmed agreement on medical device and IVD regulations. June 16th, 2016 A successful “Kick off” meeting with the Steering Committee and both MDR / IVDR working-groups took place in Brussels. A successful “Kick off” meeting with the Steering Committee and both MDR / IVDR working-groups took place in Brussels. June 13th, 2016 Medical devices : deal reached on new EU rules Medical devices : deal reached on new EU rules May 26th, 2016 The 1st meeting of the Steering Committee on MD Regulations took place in Liege. The 1st meeting of the Steering Committee on MD Regulations took place in Liege. May 19th, 2016 Survey sector Survey sector May 17th, 2016 Article in Scrip Regulatory Affair by Vibha Sharma Article in Scrip Regulatory Affair by Vibha Sharma May 9th, 2016 A new Team-NB Administrative Committee was elected during the General Assembly meeting. A new Team-NB Administrative Committee was elected during the General Assembly meeting. April 19th, 2016 Erik Hansson, deputy head of the unit responsible for medical devices within the European Commission’s Directorate General Grow, told during Team-NB 15th Anniversary meeting. Erik Hansson, deputy head of the unit responsible for medical devices within the European Commission’s Directorate General Grow, told during Team-NB 15th Anniversary meeting. April 18th, 2016 Team-NB 15th anniversary took place at the Metropole Hotel Team-NB 15th anniversary took place at the Metropole Hotel April 15th, 2016 Team-NB members attend different working groups Team-NB members attend different working groups April 1st, 2016 MEDDEV 2.7/1 Revision 4 is now at the final stage of draft for adoption. MEDDEV 2.7/1 Revision 4 is now at the final stage of draft for adoption. March 30th, 2016 General Assembly of the association will take place at the Metropole General Assembly of the association will take place at the Metropole March 30th, 2016 54th NB-Med meeting will take place on 12th and 13th April. 54th NB-Med meeting will take place on 12th and 13th April. March 30th, 2016 Transatlantic Trade and Investment Partnership (TTIP) initial position paper on Medical Devices Transatlantic Trade and Investment Partnership (TTIP) initial position paper on Medical Devices March 15th, 2016 Code of Conduct Version 3.4 has been approved by the members Code of Conduct Version 3.4 has been approved by the members March 14th, 2016 Team-NB is organising an event for its 15th anniversary. Team-NB is organising an event for its 15th anniversary. March 10th, 2016 EP ENVI Committee took place. EP ENVI Committee took place. March 3rd, 2016 Team-NB representatives will be present at IMDRF meeting, held by Commission. Team-NB representatives will be present at IMDRF meeting, held by Commission. February 2nd, 2016 2 new auditors are joining the CoC auditors’ pool : Chris Jepson and Jan van Lochem 2 new auditors are joining the CoC auditors’ pool : Chris Jepson and Jan van Lochem January 29th, 2016 Team-NB is one of the stakeholders to the first Future EUDAMED Steering Committee meeting on 19 January 2016. Team-NB is one of the stakeholders to the first Future EUDAMED Steering Committee meeting on 19 January 2016. January 18th, 2016 Guy Buijzen is Team-NB president ad interim until the vote at the next Genarl Assembly in April 2016 Guy Buijzen is Team-NB president ad interim until the vote at the next Genarl Assembly in April 2016 January 7th, 2016 Informative meeting of the Dutch EU 2016 presidency on MD/IVD Informative meeting of the Dutch EU 2016 presidency on MD/IVD December 10th, 2015 Team-NB speaker for Euromcontact Team-NB speaker for Euromcontact December 10th, 2015 Article in Clinica by Amanda Maxwell Article in Clinica by Amanda Maxwell December 7th, 2015 Article in Clinica by Amanda Maxwell Article in Clinica by Amanda Maxwell December 7th, 2015 MedpharmPlast Europe GA MedpharmPlast Europe GA November 19th, 2015 Future Eudamed Future Eudamed November 19th, 2015 Team-NB attendance to CAMD in Dublin Team-NB attendance to CAMD in Dublin November 18th, 2015 CAMD plenary in Dublin CAMD plenary in Dublin November 10th, 2015 Article in Clinica by Amanda Maxwell Article in Clinica by Amanda Maxwell November 4th, 2015 Article in Clinica Article in Clinica October 28th, 2015 NB-Med meeting open session NB-Med meeting open session October 15th, 2015 General Assembly General Assembly October 15th, 2015 NB-Med meeting close session NB-Med meeting close session October 15th, 2015 Council position on EU Medical Devices Regulation: Team-NB statment Council position on EU Medical Devices Regulation: Team-NB statment October 7th, 2015 A significant move on the way to the adoption of new regulations on medical devices: EU countries agreed on the general approach to the medical devices package. A significant move on the way to the adoption of new regulations on medical devices: EU countries agreed on the general approach to the medical devices package. October 6th, 2015 Draft regulation on MD Draft regulation on MD September 23rd, 2015 COEN guidance COEN guidance September 22nd, 2015 Negotiations Negotiations September 4th, 2015 IMDRF: IMDRF: September 1st, 2015 IMDRF meeting IMDRF meeting August 30th, 2015 Clinica “EU notified body numbers still yet to bottom out “ Clinica “EU notified body numbers still yet to bottom out “ August 8th, 2015 Clinica “TÜV Rheinland’s legal woes over PIP will strengthen NBs sector Clinica “TÜV Rheinland’s legal woes over PIP will strengthen NBs sector August 8th, 2015 Press release Press release July 10th, 2015 Michael Bothe presented Michael Bothe presented June 29th, 2015 The Council agreed The Council agreed June 22nd, 2015 Team-NB has reorganized Team-NB has reorganized May 24th, 2015 In the framework of NB transfer agreement In the framework of NB transfer agreement May 22nd, 2015 An article in Scrip Regulatory Affairs by Vibha Sharma : An article in Scrip Regulatory Affairs by Vibha Sharma : May 22nd, 2015 Important Information Important Information May 22nd, 2015 Survey sector Survey sector April 30th, 2015 Team-NB representatives Team-NB representatives March 9th, 2015 Team-NB representatives Team-NB representatives February 10th, 2015 The Code of Conduct version 4.0 The Code of Conduct version 4.0 January 29th, 2015 A revised Code of Conduct version 3.3. is now available. A revised Code of Conduct version 3.3. is now available. January 14th, 2015 General Assembly of Team-NB General Assembly of Team-NB October 20th, 2014 European Commission European Commission October 13th, 2014 Increased audit requirements Increased audit requirements September 16th, 2014 Updated Code of Conduct Updated Code of Conduct July 30th, 2014 Code of Conduct Version 3-2 Code of Conduct Version 3-2 July 22nd, 2014 Publication of working Document Publication of working Document June 17th, 2014 Survey sector on the basis of members data Survey sector on the basis of members data June 3rd, 2014 CoC 3.1 : CoC 3.1 : April 16th, 2014 General Assembly Meeting General Assembly Meeting April 15th, 2014 Kevin Butcher was elected as chairman of the CoC Board Kevin Butcher was elected as chairman of the CoC Board April 15th, 2014 Audits following the Code of conduct requirements Audits following the Code of conduct requirements April 15th, 2014 Swiss TS Technical Services AG (NB 1253) Swiss TS Technical Services AG (NB 1253) April 9th, 2014 Re-election of the Administrative Committee for 2 years Re-election of the Administrative Committee for 2 years March 15th, 2014 MDEG meeting MDEG meeting January 16th, 2014 An article in Clinica by Vibha Sharma : An article in Clinica by Vibha Sharma : December 30th, 2013 Code of Conduct enforcement : Code of Conduct enforcement : December 16th, 2013 Code of Conduct Board : Code of Conduct Board : December 9th, 2013 Auditors Pool Auditors Pool December 9th, 2013 Clinica – Amanda Maxwell wrote an article Clinica – Amanda Maxwell wrote an article October 17th, 2013 EMDT: EMDT: October 1st, 2013 Surprise! Surprise! October 1st, 2013 Preparing for unannounced EU regulatory inspections – are you ready? Preparing for unannounced EU regulatory inspections – are you ready? September 11th, 2013 An article in Clinica by Ashley Yeo titled: As MDR vote nears, EU NBs show they mean business An article in Clinica by Ashley Yeo titled: As MDR vote nears, EU NBs show they mean business August 22nd, 2013 QUESTIONS FORM on line. QUESTIONS FORM on line. July 4th, 2013 An article from Amanda Maxwell in Clinica: An article from Amanda Maxwell in Clinica: June 17th, 2013 An article from Ashley Yeo in Clinica: An article from Ashley Yeo in Clinica: June 14th, 2013 TEAM-NB-MD-Survey-PressRelease. TEAM-NB-MD-Survey-PressRelease. June 10th, 2013 Updated list of Team-NB members. Updated list of Team-NB members. May 1st, 2013 Update Notified Bodies Update Notified Bodies April 16th, 2013 “Le secteur des organismes notifiés appelé à se remodeler” “Le secteur des organismes notifiés appelé à se remodeler” April 1st, 2013 Updated list of Team-NB members Updated list of Team-NB members April 1st, 2013 Team NB Perspective Team NB Perspective April 1st, 2013 Kalitest notification Kalitest notification March 21st, 2013 The Parliament Magazine – CEOC, EUROLAB and IFIA The Parliament Magazine – CEOC, EUROLAB and IFIA March 11th, 2013 Following Mr. Geoff Hines retirement on March 2013, Following Mr. Geoff Hines retirement on March 2013, March 6th, 2013 R-TEAM-NB-PressRelease-VisionOnRevision R-TEAM-NB-PressRelease-VisionOnRevision February 26th, 2013 « Code of Conduct Version 3 signees 2012 » « Code of Conduct Version 3 signees 2012 » January 1st, 2013 Code of Conduct Version 3 signees Code of Conduct Version 3 signees November 30th, 2012 Please note that the GHTF website Please note that the GHTF website November 28th, 2012 Team-NB participated in the panel discussion on Team-NB participated in the panel discussion on November 8th, 2012 Code of Conduct Version 3 signees Code of Conduct Version 3 signees October 30th, 2012 Team-NB position regarding the Telegraph article Team-NB position regarding the Telegraph article October 23rd, 2012 Team-NB-Press-release-COC Team-NB-Press-release-COC October 10th, 2012 Code of Conduct Medical Notified-Bodies v3-0 Code of Conduct Medical Notified-Bodies v3-0 October 9th, 2012