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Informa

11 - 15 June 2018
Hotel Okura,
Amsterdam

Achieve successful EU MDR & IVDR implementation through direct access to competent authorities, notified bodies and industry

Thank you to everyone who attended the MedTech Summit 2017

Including clinical strategies, PMS & vigilance, legal, combination products, companion diagnostics, and emerging markets requirements

MedTech Summit 2017 on film...


Watch the video for a glimpse of the MedTech Summit 2017 in Amsterdam.

Over 400 attendees from the medical device, diagnostics and combination combination product communities gathered in Amsterdam for all the latest EU MDR, IVDR and Emerging Market Regulation updates. The agenda covered 8 crucial areas: EU MDR, IVDR, Post Market Surveillance and Vigilance, Clinical Evaluations and Invetsigations for Medical Devices, Medical Device Law, Drug Device Combination Products, Regulatory Affairs in Emerging Markets, and Companion Diagnostics.

MedTech Summit 2017 Testimonials


Attendee Testimonials:

“Excellent summit with a good combination of notified bodies, competent authorities and industry”

"Attending the MedTech Summit is an excellent opportunity to learn about new regulations in a comprehensive and compact way and introduces several options on how to implement and fulfil resulting requirements"

"Informative meeting with excellent networking opportunities"

"MedTech Summit – educating and inspiring event"

Sponsor & Exhibitor testimonials:

"Very good contacts and new business as a result of sponsoring and exhibiting"

“Very good meeting. We made lots of good new contacts and found the Mobile App very useful”

“Great meeting, very comprehensive and high level professional attendees”


MedTech Summit 2017 Event Highlights:

EU Medical Device Regulation PLUS EU Medical Device Law
  • Implementing the new MDR: Regulator, Notified Body and industry perspectives
  • How can you set up a successful transition plan under the new MDR?
  • Sharing thoughts and concerns on the Notified Body re-designation process
  • How will the MDSAP program impact industry?

EU Medical Device Law Focus Day

  • Examining new liability rules under the MDR
  • Transitioning to an implementation plan: gap analysis and resource
  • Assessing the legal obligations of manufacturers, importers and distributors
IVD Regulatory & Strategic Forum PLUS Companion Diagnostics
  • Implementing the IVDR – Regulator, Notified Body and industry perspectives
  • The new classification system for IVDs: what does this mean for industry? 
  • Demonstrating conformity with safety and performance requirements for clinical evidence and legacy products

Companion Diagnostics Focus Day

  • What are the implications for CDx under the new EU IVDR?
  • Ensuring optimal partnerships between diagnostic and pharma companies

See the companion diagnostics 2017 agenda

Post Market Surveillance & Vigilance
  • Compiling PMS plans and meeting requirements of the new MDR
  • Ensuring best practice for Field Safety Corrective Action (FSCA) reporting
  • How should Post Market Clinical Follow-Up (PMCF) activities be implemented?
  • Complying with regulatory requirements for trend reporting
  • What are the new timelines for post-market reporting?
Clinical Evaluations & Investigations for Medical Devices
  • Clinical investigation applications under the new MDR - Regulatory perspective
  • What are the new clinical evidence requirements for class III devices?
  • Understanding MEDDEV 2.7.1 Rev 4: Regulator and industry discussions
  • How should you implement a successful clinical investigation strategy?
  • Exploring patient recruitment - from study design to execution
Medical Device Regulatory Affairs in Emerging Markets
  • Accessing the exemption list and achieving compliance in Chinese clinical trials
  • What are the current and upcoming plans for dossier designs in the ASEAN region?
  • INMETRO Ordinance 54/2016 in Brazil for electro medical devices
  • How can you navigate the approval requirements in Saudi Arabia? 
  • Examining Russian clinical trial requirements and expectations

Drug Device Combination Products
  • What are the implications for combination products under the new EU MDR?
  • FDA latest regulatory updates and requirements
  • How can you operate in a heterogeneous global regulatory environment?
  • Reviewing the newly introduced Rule 21 on classification of substance-based devices
  • Implementing human factors testing and "user centric designs"

MedTech Summit 2017 Agenda Breakdown


To find out more about the individual event tracks, take a look at the online agenda and select the days of interest...

FREE ON-DEMAND CONTENT

WEBINAR:
Navigating the challenging transition to the new EU MDR: An interview with Bassil Akra, TÜV SÜD Product Service GmbH

Amanda Maxwell interviewed Dr. Bassil Akra on Tuesday 23 May to get a Notified Body perspective on the changing medical device regulatory landscape, and the impact it will have on industry. The webinar explores the advantages of the new European medical device regulations, discusses the expected challenges surrounding regulatory implementation, assesses the timelines for implementation, and lots more.

Led by:

Amanda Maxwell, Medtech Regulatory Affairs Editor, MedTech Insight, Informa, UK

Dr. Bassil Akra, Vice President - Global Focus Teams (Cardiovascular, Orthopedic and Clinical), TÜV SÜD Product Service GmbH, Germany 

Click here to download the webinar slides

450+ industry experts preparing for the new MDR and IVDR

18
Competent Authority and Notified Body Representatives Speaking
7/10
Top Global Medical Device and IVD Manufacturers
250+
Device and Diagnostic Companies Attending

The expected impact of the EU MDR according to key-opinion leader Gert Bos


Free On-Demand Webinar

What will the webinar cover?

  • 10 most critical changes
  • Key impact for manufacturers
  • Practical approach on hot issues (clinical evaluation, OBL)
  • Notified Body situation, risks and precautions
  • Tools for help with the impact of the MDR

Led by: Dr.Ir. Gert Bos, Executive Director and Partner, Qserve Group

Sponsorship and exhibition opportunities

Promotional Participant

Medical Device Training International | MDTI


MDTI is a global interactive training partner committed to the personal progression of Medtech professionals. We deliver CPD certified training on a wide range of topics including clinical evaluations, clinical investigations, regulatory affairs, combination products, PMS and vigilance, In Vitro Diagnostics (IVD)and soft skills. Our courses are delivered in a variety of formats such as public face-to-face, customised in-house, webinars, eBooks and online academies.