Capacity Building Initiative for Trade Development in India (CITD)

Medical Devices Activity

Agenda

Venue:

  • Hotel Royal Plaza, 19 Ashoka Road, Connaught Place, Delhi on 23 Aug 2016
  • The Pride Plaza Hotel, Judges Bungalow Road, Off S.G. Road, Ahmedabad on 24 Aug 2016
  • Hotel Fortune Select Palms, 142, Rajiv Gandhi Salai – Thoraipakkam, Chennai on 26 Aug 2016
  • Hotel The Lalit, Sahar Airport Road, Andheri Est, Mumbai on 27 Aug 2016

Programme: One Day Awareness Seminars on EU Medical Device Directives and Related Regulations

Date:As mentioned above

Start Time / Session Topic / Objective
08:45-09:15 / Course Registration
09:15-09:45 / Opening Remarks
-Introduction by NABCB
-Relevant Honorable Invited Speakers
-CITD Project Objectives, Mr. Nicola Antonopoulos,
Key Expert for Technical Regulations. / Brief presentation of the CITD project, of the present seminar, of the speakers and their backgrounds.
09:45-10:00 / Break
10:00-11:00 / What is a Medical Device or Diagnostic? The Key Directives, Blue Guide, The Key Actors, Conformity Assessment Procedures and the Risk Based Approach to Classification, with examples and delegate interaction. / Introduction to the fundamentals of EU medical device regulation.
11:00-12:00 / The Essential Requirements and Technical Documentation – what is needed and where to find detailed guidance. The vital importance of using standards wherever possible with examples. / Information on the heart of CE marking – the ERs and standards.
12:00-12:45 / The importance of ISO 13485 for Quality Management System (QMS) implementation and ISO 14971 to Risk Management.This will include brief comments on the Commission Recommendation on Audits and the International Medical Device Regulators Forum Single Audit Program. / Introduction to the use of global standards for QMS and risk. Comments on unannounced NB audits will be included.
12:45-13:30 / Lunch Break
13:30-14:00 / Specific In Vitro Diagnostic (IVD) considerations to ensure robust compliance. The use of standards and other specific IVD guidance. / To provide useful IVD compliance insights.
14:00-15:00 / Clinical Evaluation of Medical Devices, including use of ISO 14155 for clinical investigation planning. / Introduction to clinical evaluation.
15:00–16:00 / Positive Post-Market Surveillance (PMS) and Vigilance. Linking back to ‘CAPA’ ! / Introduction to PMS for real business benefits and what to do if things go wrong.
16:00-16:15 / Break
16:15-17:30 / The new Medical Device and In Vitro Diagnostic Regulations (MDR - 355 pages & IVDR - 306 pages)
– Important points and the direction of travel. / An introduction to the texts published during June 2016 and pragmatic advice.
17:30-17:45 / Presentation of the Indian Certification of Medical Devices Scheme (ICMED) / NABCB
17:45-18:00 / Q&A Session and Closing Remarks.