Mapping Your Success 2013 BSI Healthcare Road Show
Welcome & Outline Objectives for Today Please let me introduce myself.. Gary Slack Global Director BSI Medical Devices Based London 2
Changing Global Regulatory Environment for Medical Device Manufacturers The regulatory roadmap is undergoing unprecedented change in many regions of the World. Its vital that regulatory experts within manufacturers ensure they are up to date with the evolving essential requirements in key geographies.. EU 28 Member States US FDA Japan JPAL China CFDA (Formerly SFDA) Brazil ANVISA TGA Australia More! 3
Key Geographical Changes Europe: All Three EU Medical Device Directives are undergoing significant change over the next 2 years the MDD, AIMD and the IVDD. Key Dates AIMD/MDD ENVI vote postponed from 18 th to 25 th September at 10.00 am 18 th September 2013 (this week!) - EU ENVI Committee Vote on the proposed amendments. November 19 th Commission Trialogue Debate Adoption new MDR in 2014 with a transition period (2016?) 4
Key Geographical Changes The Majority of Todays Programme will relate to EU Changes, however, BSI can also help understand / discuss the proposed changes in the other regions below. US: Significant change is imminent for medical device facility audit with the proposed Medical Device Single Audit Programme (MDSAP). Initiated by the US FDA with Canada, Australia and Brazil initially linked to IMDRF. Australia: Device manufacturers of all Class Devices (including AIMD)will be able choose to have their conformity assessment certificates issued by an EU notified body rather than being limited to using the TGA. Japan: Ministry Health Labour & Welfare (JPAL) look to open up Japanese Class III (= EU Class IIb) products to Third Party Providers To speed up new product registrations 5
So to The Outputs from Today We aim to provide delegates with insight to recently enacted and current EU regulatory requirements relating to. Changes (already enacted) to the risk management standard in Europe (New Annex Z) Mobile Health: Software, Mobile Phones and Telemedicine under the EU Approach Update on the latest requirements within the EU relating to Animal Derived Material EU electronic Labelling requirements to EU 207/2012 6
So to The Outputs from Today. We aim to provide delegates with the latest insight to the proposed EU Regulatory Changes Specifically. Increased Clinical Investigation Requirements (CIR) Increased Expectations with respect to Post Market Clinical Follow Up (PMCF) Unique Device Identification (Implications of CIR and PMCF) 7
Working with BSI! Product Certification EU / FDA / JPAL / TGA / SFDA / MDA (Malaysia)/ ANVISA (Brazil) / GHOST (Russia) BSI has >110 Product Experts located primarily in the US, UK, France, Germany, Netherlands, Sweden, Russia, Australia, India, Japan & China. Medical Device Auditing to ISO 13485 we have global coverage with Auditors in 23 worldwide office locations. The BSI objective in Medical Devices is to... Making Excellence a Habit in ensuring rapid full market access for all of our clients across all continents to all continents 8
BSI appreciate you taking your time out of what we know are busy schedules to attend todays event. We hope you will find today informative and that the presentation material, discussions and networking opportunities, have real practical value when you return to your respective organisations Thank You 9