Skip to main content

Preparing for The New EU Medical Device Regulations (MDR): Strategies and Tactics

Compliance Key INC - Medical Device Training

David R. Dills, Regulatory Affairs & Compliance Consultant is a Keynote Speaker at Compliance Key INC provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 24 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.

  Seminar Id: IJ2018S4
 6:00 AM PT | 9:00 AM ET
 03/09/2018
 Duration 1 Day
Overview
The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation. We will provide our attendees with an understanding of the Transition Provisions, Re-Certification and Reclassification Components of MDR.

The European Union released the Medical Devices Regulation (MDR 2017/745/EU) to eventually replace the Medical Devices Directive and Active Implantable Medical Devices Directive. The MDR introduces numerous changes, including a shift from the pre-approval stage to more of a life-cycle approach. It also incorporates a variety of European guidance documents (MEDDEVs) into the regulation and emphasizes the importance of Post-Market Surveillance (PMS), clinical data, clinical evaluations, and Post-Market Clinical Follow-up (PMCF). MDR compliance presents many new challenges to medical device manufacturers. 

Why should you attend this seminar?

  • Understand the Medical Device Regulations approach in Europe
  • Understand the structure and purpose of the Medical Device Directives 
  • Explain the use of Essential requirements, including the use of (harmonized) Standards
  • Understand the key changes upcoming in the new EU MDR 
  • Understand the essence of early start in the transition 
  • Understand how to prepare a transition plan
  • Apply the Classification Criteria and Implementation rules
  • Identify the conformity assessment routes 
  • Identify Technical Documentation requirements 
  • Importance and Role of Clinical Data 
  • Identify the importance and contents of Post Market Surveillance
  • Explain and differentiate between the scope of the three EU device directives
Areas Covered in the Session:

  • Introductions and Background
  • The objectives of the MDR
  • Scope & Definitions
  • Placing CE marked product on the market
  • EUDAMED and significance of the European Electronic Database
  • Notified Bodies
  • Classification and Conformity Assessment
  • Clinical Evaluation & Investigations
  • PMS and Vigilance
  • Quality management system requirements in the MDR
  • Device classification and conformity assessment routes changes in the MDR
  • Technical documentation requirements
  • Clinical evaluation process requirements 
  • UDI and traceability requirements 
  • Postmarket surveillance and reporting requirements 
  • Life-cycle review of products linked to risk management and clinical evidence
  • Implications for Notified Bodies, and for organizations working with Notified Bodies
  • Impact on product portfolios and classification
  • The need for improved clinical evidence
  • Strengthening of post market surveillance (PMS)
  • What do our employees need to know about the MDR to maintain compliance?
  • How can we prepare to recertify to the MDR?
  • General obligations of the medical device manufacturer
  • Uploading data and maintaining compliance with EUDAMED
  • UDI in Europe and how it compares with US FDA UDI requirements and traceability of the supply chain
  • Classifying medical devices under the European MDR
  • Conformity assessment procedures and the role of Notified Bodies
Who can Benefit:

  • Class I, II and III/In Vitro Diagnostic medical device manufacturers
  • Contract medical device manufacturers
  • Contract sterilizers
  • Repackagers, relabelers, specification developers, reprocessors of single-use devices
  • Manufacturers of accessories and components sold directly to the end user 
  • U.S. manufacturers of "export only" devices
  • Distributors 
  • Importers
  • User Facilities (e.g., hospitals, nursing homes)

Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

New 2019 HIPAA Guidance on De-Identifying Protected Health Information

Compliance Key  -   HIPAA Compliance Training Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle  has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you attend this seminar? This Sem...
Post a Comment
Read more

Classifying Medical Devices in US and EU

Compliance Key INC  -  Healthcare Compliance Webinars Overview The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.The determination process, how you apply the classification process to your device, is complex and requires several levels of analysis to make the proper device classification. Proper medical device classification is the fundamental first step in submitting your device for approval anywhere in the world. This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provid...
Post a Comment
Read more

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Compliance Key INC  -  H ipaa webinar                                           Jonathan P. Tomes Jonathan P. Tomes , J.D., is Keynote Speaker at Compliance key Inc. He is a health care attorney practicing in the greater Kansas City.   Webinar Id:   HIPHJPT001  2:30 PM PT | 03:30 PM ET    01/18/2018  Duration: 60 mins  Overview Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the necessary actions to prepar...
Post a Comment
Read more