Medical Devices Regulations: Incorporating biological tissue requirements
The regulatory requirements for manufacturers of medical devices incorporating materials of biological origin (e.g. animal tissue/derivatives, non- viable human tissues/derivatives) can be challenging. BSI understands that the utilization of materials of biological origin in your device can bring added benefits but that the regulatory process will be subject to increased scrutiny.
Additional demands include justification for the use of the tissue or derivative, and information relating to sourcing and processing controls.
The Medical Devices Regulation (MDR, 2017/745/EU) replaces the Medical Devices Directive (MDD, 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD, 90/385/EEC), and has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
The scope of the new MDR has expanded to include the following:
- Devices manufactured utilizing derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable (Article 1)
The wording of Rule 18 has changed to include devices utilizing cells or tissues of human origin, or their derivatives, which are non-viable or rendered non-viable. There will be limited changes to the way that devices utilizing tissues/derivatives of animal origin are assessed, other than to include the additional requirements for UDI, PMS, clinical evaluation etc.
This webinar will discuss the implications of the new MDR on manufacturers who utilize biological tissues or their derivatives, and highlight some key points of note for manufacturers as they plan for the transition to the new Regulation.
Dr. Jennifer Durrant is a BSI Product Specialist designated by the MHRA to review Medical Devices utilizing animal tissues or derivatives, including those for which a TSE risk is suspected, and woundcare devices.
Jennifer spent 10 years within the pharmaceutical and medical device industries and has extensive experience in R&D of biological products utilizing animal tissues and derivatives, including the manufacture of cGMP-compliant cell banks, collagen manufacture, viral elimination/inactivation studies, viral safety/biosafety, design, manufacture, validation, risk management activities for ATMPs and devices utilizing animal tissues/derivatives, regulatory affairs and quality assurance for advanced therapy medicinal products and Class III devices, and global regulatory approvals for Class III devices utilizing animal tissues/derivatives.
Jennifer has a PhD in Cell Engineering Studies on Human Skin Cells; Implications for Dermal Wound Repair and an undergraduate BSc (Hons) Biomedical Sciences.