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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.

 

Dr. Sanjeev Kumar Gupta Managing Consultant, Intrust-Consulting LLP A-301/A Green Heritage, Sector 20, Kharghar 410210, Navi Mumbai (Maharahstra), India +919879617573 Info@intrust-consulting.com , intrust.info@gmail.com www.intrust-consulting.com