Medical Device & In
Vitro Diagnostic Devices:
MDR 2017 and Industry Preparedness
In addition to above applicants would
require several levels of technical documents to support
their applications for licensing. The technical documents
submitted on portal help regulatory officers to gain
knowledge about company (administrative documents and Site
Master File), its product development activities (Design &
Development), product characteristics (Device Master File,
Appendix II for MD and Appendix III for IVD), safety
through Risk Management Report & Essential Principles
Checklist and effectiveness through Clinical Investigation
(Medical Devices), Performance Evaluation and Clinical
Performance Evaluation Reports for IVD.
As these come under Rules many products
may now need to be subjected to structured clinical
studies to generate authentic technical documentation.
Such evaluation may be time and money intensive. A number
of manufacturers may find it difficult and may again need
services of Experts & Consultants who have domain
knowledge and experience in clinical studies. The
preparedness requires contacts and working contracts with
CMTDL, MDTL and NABL laboratories (Box 2).
Among various preparedness manufacturers
would also need to identify applicable technical standards
to ensure safety and effectiveness of products. The MDR
2017 explicitly emphasize that manufacturer must
demonstrate compliance to a) CDSCO standards, b) BIS
standards, c) ISO & other international standards and d)
Manufacturer’s in-house standards in order of
availability.
The working towards so much of
preparedness for compliance can be intimidating in terms
of time, money and efforts. However, it can be very
rewarding and may enable industry to think for global
markets since most markets have overlapping regulation.
Box-2 Industry need to select CMDTL,
MDTL and NABL in sequence of availability for Performance
Evaluations.
CMDTL: Central Medical
Device Testing Laboratory such as
Sri Chitra Institute of Medical Sciences for MD
and NIB for IVDs
MDTL: Medical Device Testing Laboratory such as
NIV, Pune
NABL Accredited Labs: > 2500 labs across
country Clinical Investigations and Clinical
Performance Evaluations can be
conducted at NABH accredited hospitals in accordance
with Rules. |
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