Day Three – 12 June 2024Wednesday, 12 June 2024 - CEST (Cent Europe Summer, GMT+2)

The revised draft of the new Part 1 has brought about multiple changes so join us as we discuss its effects on the biological evaluation process.

• Overview of biological risk assessment per ISO 10993-1:2018
• What’s on the horizon for biological risk assessment per revisions that are currently under discussion
• Illustration of biological safety evaluation using a true risk assessment approach through a case study

• Conformity assessments for Class D
  • Current requirements from Notified Bodies
  • Challenges for manufacturers
• A focus on current common specifications
  • What changed within the new version?
  • How much effect does this change have on industry?
  • How are notified bodies ensuring compliance to these specifications?

• Feedback on the status of EU reference laboratories.
• How many EURLs are currently designated, what do they cover?
• How do notified bodies work with EURLs?
• Impact on notified bodies and manufacturers after EURL designation, taking into account IVDR transition periods.
• Possible process for IVD approval with EURL involvement based on IVDR requirements.
• What if there is no EURL for an class D testing scope yet?
• How do notified bodies work without EURLs?

• About FDA and the Center for Devices and Radiological Health (CDRH)
• Definition of a Medical Device (Intended Use, Technology)

• Premarket Notification – Traditional, Abbreviated, Special
• 510(k) Exemption
• De Novo Classification
• Premarket approval (PMA)
  • Modules, modular and full submissions
• 513(g) Request for Classification

• Breakthrough Designation and Step Program
• The 510(k) Process, Different types of 510(k)
• Predicate Devices & Substantial Equivalence
• Contents of a 510(k) submission
• The De Novo Process & Drafting De Novo Requests
• Post-market Device Modifications

• The PMA process and different types of PMAs
• Contents of a PMA submission
• Summary of Safety and Effectiveness Data (SSED)
• PMA Annual Reporting
• Advisory Panels
• Manufacturing Inspections
• Modifications to Approved Devices

• Proper study design and thorough planning that considers device-specific intricacies in sample preparation is crucial for a successful biological evaluation. Improper sample preparation or extraction conditions can lead to additional evaluation time, testing costs, and animal use.

  In this session, we will discuss some of the main contributing factors associated with:

  • Improper test article preparation.

  • Improper extraction conditions.

• Where are the notified bodies and EU Reference Laboratories with the implementation of EU 2023/2713?
• What are the potential scenarios for conformity assessment of legacy Class D devices before and after October 1, 2024.
• What can manufacturers do to prepare for the implementation of the EURLs oversight process.

• EU Chemicals regulation updates – (REACH (One Substance One Assessment (OSOA), Essential Use), CLP, RoHS, Safe and Sustainable Chemicals.
• EU Circular Economy – Batteries, ECO Design and Sustainability for Products Regulation, Packaging and Packaging Waste Regulation, Packaging Labelling Directive, Waste Framework, WEEE and Extended Producer Responsibilities, Right to Repair, Critical Raw Materials
• EU Reporting – CSRD, Modern Slavery, Conflict Minerals, Supply chain Due Diligence

What is the practical impact of IVDR for health institutions, both when new CE-IVD kits come onto the market and when CE-IVD kits are (temporarily) taken off the market? Where can health institutions collaborate with industry to increase patient safety?

• What is Q-submission (or ‘pre-submission’)
• When is it helpful?
• How to Prepare the Q-Sub Package for FDA
• How to Prepare for the Feedback Meeting
• FDA Feedback & Follow Up

• Manufacturing Requirements
  • Quality System Regulation: 21 C.F.R. Part 820
  • A Look at Upcoming Harmonization with ISO 13485
• Complaint Handling and Medical Device Reporting: 21 C.F.R. § 820.198, Part 803
• Conducting and Reporting Recalls: 21 C.F.R. Parts 7 and 806

With the recent updates and newly revised ISO 10993-1, join us in discussion as we navigate the anticipated effects of these regulatory changes.

• Revieing New Approach Methodologies (NAM)
• Identifying the various types of sensitizers that leach from medical devices
• Data initiatives tox reports and literature

• Potential Shortages of Commercially Available tests and an expected reduction in labs able to use IH-IVDs (LDTs for routine testing purposes with Precision Medicines
• Potential delays in clinical trials of Precision Medicines using IVDs with a medical purpose.

• What is the impact of IVDR on the ability to enroll patients into trials?
  • How is IVDR impacting trials that have patient selection and further what is the impact to inclusion/exclusion and assays/data used for medical management?
  • How is country by country variability impacting trials and how divergent are the various opinions?
• What is the expected impact of the US LDT regulations and what is different/the same to IVDR?
• What infrastructure is needed to support these changes for drug developers, sites and laboratories?
• Have laboratories managed to meet the requirements of IVDR and what are the current gaps?
• What infrastructure does the industry need to build for a better future state?

• First IVDR Certificates have been issued end of 2020 – First Recertification is ahead!
• Impact of transitional provisions on legacy devices – MDCG 2022-8 provides some clarity.
• Which Surveillance requirements need to be fulfilled for specific IVDs?
  • PSUR versus PMS Report
  • SSP – PMPF -Continuous update of PER
  • Regular IVDR QMS Audits
• Which data, which time intervals are expected?

• Determining proposed indications for use
• Formulating a regulatory strategy – premarket pathway and predicate device
• Preparing a verification and validation testing plan
• Seeking feedback from FDA
• Assembling the premarket submission

Device makers enrolled in the Voluntary Improvement Program (VIP), a part of the FDA’s Case for Quality initiative, have learned to design, build and deliver safer products to patients faster by shifting to a continuous improvement mindset. VIP focuses on quality, so attendees will learn how shifting from tactical to strategic thinking, and pursuing systemic changes in their programs, will deliver lasting benefits beyond addressing individual problems.

• Dissecting and explaining the requirements of MDR GSPR 10.4

• Examples of hazardous substances

• Determination whether hazardous substances are present above 0.1% w/w

• To Do’s when hazardous substances are present above 0.1% w/w

• Meeting regulatory expectations in biocompatibility testing for medical devices

• Biocompatibility challenges during MDR certification of legacy devices.

• Addressing the “gap’ between regulatory expectations and industry practices

• Current requirements for adverse events, FSCAs and trend reporting
• Similarities and differences across regions
• UK Case study: filing an adverse event on new MORE Web Portal
  • Differences between UK & Northern Ireland

Have burning questions left over from the last 2 days? Take the opportunity to connect with our speakers and raise those final questions in our ‘Ask the Experts’ panel!