MDD to MDR Transition
Why is the modification in the regulation (MDD to MDR Transition) adapted?
History: You may be aware of the breast implant scandal in France wherein instead of medical grade Silicon, a low-quality Silicon was used as a raw material for breast implants which got ruptured and there were several complaints filed which led to the recall of the device by the manufacturer.
Because of these kinds of incidents, the MODIFICATION to MDD came into the picture and it’s called MDR, which is more comprehensive and detailed than MDD.
How do we adapt to MDR?
Gap analysis while considering additional requirements of MDR.
Refer Annexure XVII of MDR
MDR focuses on the safety and performance assurance of the devices placed on the market. MDR assures that the product causes no harm to the customers. Clinical and Non-Clinical testing methods include Clinical Investigation, PMCF studies, Literature Searches Screening and Appraisal, bench tests, in-vitro tests, biocompatibility testing, and product-specific performance Tests (if any) are utilized to establish clinical evidence for demonstrating the safety and performance of the device. The Manufacturing facility audits are conducted as per ISO 13485 to comply with Cleanroom requirements and applicable standards. Corrective and Preventive Actions (CAPA) needed to be taken depending upon the severity of complaints generated through Field Safety Notices/Field Safety Corrective Actions. The IFUs and electronic IFUs are to be supplied by the manufacturer. Product retractability with UDI implementation has become a must for troubleshooting and the appropriate diagnosis of the complaint or defect related to the product.
Let us identify the requirements in MDD to MDR transition.
The major changes to be adapted in MDR.
MD Classification
Clinical Data Sources
Risk Management
Process Validation
Software Validation
GSPR checklist
Product Retraceability
Major Inclusions in MDR
PRRC
SRN for Economic Operators
Annexure XVI includes products without an intended medical purpose like contact lenses, brain stimulators, cosmetic products, etc.
Active Implantable Medical Devices
Sterilization
EN ISO 13485 and MDSAP Requirements
Conformity Assessment Routes
EUDAMED, UDI and Labelling
Technical Documentation
Clinical Evaluation
Clinical Investigation and PMCF
Reporting of serious incidents or failures to member states and trend reporting
IFU and eIFU Requirements
Cybersecurity
SSCP linked to EUDAMED open to all end-users (including a layman)
GSPR
We at IZiel Healthcare have a long-standing collaboration withObelis,a Belgium-based (European Authorized Representatives) to provide a “One-Stop Solution” to fully support Class I, IIa, IIb & III medical device manufacturers across USA, Europe & Asia. This collaboration would ensure to obtain conformity with the MDR (2017/745) requirements and maintain the CE Marking of global medical devices through technical support, consultancy, representation, and device registration services.