MEDICAL DEVICE

Medical Device

Medical Devices are one of the most important sectors in healthcare. With advancing technologies and rapid innovations medical devices are one of the fastest growing industries. To accommodate with the rapid changes, medical device regulations are also very dynamic and changing very fast. The regulatory compliance is also growing as the various regulators are making the requirements more stringent. The industry as a whole is shifting from a reactive to a proactive approach across all aspects from research and development (R&D) all the way through to distribution. Medical device manufacturers are being required to submit more data on their processes and products than ever before. Thus, in today’s market, medical device companies need a proactive global regulatory strategy for rapid commercialization. We at IPRA understand your need and offer strategic guidance for India Registrations, CE Marking, ISO 13485 implementation, Clinical Investigation, and Approvals with various Regulatory Authorities.

We provide following services for Medical Devices.

1. India Regulatory Services

a. Manufacturing License

b. Import License

c. Permission to conduct Clinical Investigation of Medical Devices

d. Compliance with Quality Management System

e. Wholesale Distribution License (Form 20B and 21B)

f. Test License

2. CE Marking Services as per EU MDR 2017 / 745

3. ISO 13485 Certification

ISO 13485 Consulting

Introduction

ISO 13485 Certification is the world’s most accepted and followed international Quality Management System (QMS) standard by the medical device industry. QMS is designed to help manufacturers comply with regulatory systems and understand what they need to do to place compliant devices on markets throughout the world. It is a collection of policies, processes, documented procedures, and records to be followed by an organization.

The most important point about ISO 13485 is that it is often used in a regulatory environment. Medical device manufacturers use it to implement an effective management system to meet regulatory requirements of the most of the countries.

IPRA is specializes in helping organizations become ISO 13485 compliant and achieve ISO 13485 Certification. We do quality consulting for the Medical Devices Industry to offer you expert guidance & know-how, coaching & mentoring, online and onsite training, templates and everything you need to achieve ISO 13485 Certification. We help in creation of the SOPs, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the next phase, we assist to implement the system at shop floor and provide the need-based training to make sure that the system is adequately implemented.

CE Mark Consulting Services

Introduction

The CE Mark on a product indicates that it complies with all the applicable requirements of the European Union. Obtaining the CE Mark allows your company to freely commercialize the product in the European Economic Area (EEA).

To obtain CE mark for Medical devices, manufactures are now need to comply with the new Medical Device Regulations (MDR) 2017/745. Manufacturer need to demonstrates compliance with general safety and performance requirements Annex I of MDR 2017/745. With the commencement of MDR, requirements have become more stringent.

What is MDR 2017 / 745

MDR 2017 / 745 is new regulation for medical devices in Europe.
On April 5, 2017, the EU adopted the new Medical Device Regulation, replacing the two existing directives, the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD).
This means that MDR is required to access the European market (EU member states, the members of the EEA – Iceland, Lichtenstein and Norway, and through bilateral treaties Switzerland)
NO Grandfather Status – Existing devices will NOT be automatically grandfathered into the new Regulation without complying with the new MDR requirements. Means, NO CE Certificate transfer from MDD to MDR.

MDR 2017/745 vs MDD

Regulation vs Directive
175 pages document vs 60 MDD
123 articles and 17 Annexes vs 23 articles and 12 Annexes
MDD and AIMDD integrated into MDR
MEDDEV guidelines integrated
Shift from pre approval stage to ‘life cycle approach’
More EU Control
More NB Harmonization
Active from 26 may 2020 (Will be delayed by a year due to COVID 19 Outbreak)
New MDR CE certificates has to obtaine for existing devices.

MDR Impact

Minimum 1 unannounced audit mandatory
Reinforced conformity assessment on Notified Body (NB) and other economic operators (including manufacturer, Authorised Representative, importer, distributor)
Clearer obligations for economic operators.
More stringent requirements for documentation: Requirements are much more detailed regarding both content and regular updates of technical documentations and there is an increased focus on clinical assessments. Importantly, there will be no differentiation between class III product documentation and the other classes.
More stringent requirements for clinical evaluation.
New classification rules. (such as introduction of rules for medical devices with non medical purpose.)
New requirement: Appointment of PRRC (Person Responsible for Regulatory Compliance)
Notified bodies more strictly regulated
Extended scope: now includes devices with non-medical purpose
New scrutiny procedure for high risk medical devices
Enhanced market surveillance by Authorities
EUDAMED: Europe-wide database for more transparency and cooperation
Greater emphasis on supply chain traceability.
UDI: unique device identification number for every medical device.
PMCF is mandatory for all devices. Annual reporting of PMCF Report is mandatory.
PMS is proactive.
IFU, label and summary of safety and performance (criteria for CE approval) will be made public.
Damage compensation – pre requirement for Clinical investigation.
Italian Medical Device Codes (CND) will replace GMDN in Europe.
Under MDR, class III implants and active class IIb products which are intended to administer and/or remove medicinal products from the body are subject to a double safety mechanism. First, these products must undergo clinical consultation with expert panel before they are placed on the market. Once on the market, they might be put through a scrutiny process.

CE Marking Services

We have the experiences and expertise preparing technical file and can work with any Notified Body of your choice. We can assist you to switch smoothly from MDD to MDR by auditing the gaps in the existing documents or creating new documents.

Medical Device Technical File should be prepared as per MDR 2017 / 745 Annex II. Technical file should be clear, well-organized, readily searchable and unambiguous manner to demonstrate the safety and performance of the device.

Irrespective of a device class, intended use, construction and or safe history of the device, the manufacturer must have and keep up-to-date technical file to demonstrates compliance with general safety and performance requirements Annex I of MDR 2017/745. Rbridge can help you with following services.

Preparation of Technical File as per MDR
Transition of existing technical files from MDD to MDR
GAP Analysis in the existing documents
Risk Management Report
1. GAP analysis in exiting Risk management report
2. Performs Risk Identification and Benefit-Risk Analysis with the support of the manufacturer
3. Sets up Risk Management documents such as Risk Management Plan (RMP), Hazard Traceability Matrix, Risk Management File (RMF), etc. with the support of the manufacturer

Clinical Evaluation Report Preparation
1. Gap analysis in existing Clinical evaluation report
2. Identifies the equivalent/similar device with same risk biological clinical and technical equivalency with the support of the manufacturer
3. Identifies patient population, clinical conditions, contraindications, warnings with the support of the manufacturer
4. Prepare Clinical Evaluation report, Post Market Surveillance Report and Periodic Safety Update Report
Device Classification
Strategies for conducting tests such as Evaluation of Safety, Biocompatibility, Physical characterization tests, Chemical characterization tests, Stability studies, Validations, Verifications, etc. with the support of the manufacturer.
Supports in biological evaluation documentation and testing
Helps in identifying the Notified Body and submitting the MDR/IVDR Application
Prepares Usability Engineering Documentation
Help manufactures to prepare PMS plan and PMS report/PSUR.

India Regulatory Services

Introduction

With the implementation of new Medical Device Rules 2017 (“MDR 2017”), Indian medical device regulations have become more streamlined with the global regulatory requirement. In tune with the global practice, the 2017 Rules have introduced a risked based classification system and classified medical devices in to 4 classes A, B, C and D.

CLASS A------LOW

CLASS B------LOW-MODERATE

CLASS C------MODERATE-HIGH

CLASS D------HIGH

India has opted a mixture of US and EU Medical Device Regulatory system. Indian Regulatory Authority, CDSCO has designated some Notified Bodies like EU system. These Notified Bodies audit the quality system of the low risk device manufacture. However, for high risk devices CDSCO have kept the full regulatory control with themselves like US.

We at IPRA can help you with complete regulatory support for your India operations. Our services are –

a. Manufacturing License

We help customers to obtain the manufacturing license by preparing the dossier as per CDSCO requirements, submitting the dossier to SUGAM portal and responding to the queries raised by Authorities.

b. Import License

India has notified some medical devices. Companies need import license to import these devices in India. We help the customers to search predicate device and compare the Indian predicate device with the device under registration. We prepare the dossier, submit to CDSCO portal, respond to the CDSCO queries to obtain the license.

c. Permission to conduct Clinical Investigation of Medical Devices

India classifies any device which is first time is in India as “NEW DEVICE”. New devices require Clinical investigation permission. Also, claims for new intended use or new population or new material or major design change may also need clinical investigation.

If a medical device is not a “New Device” for India but does not have a Free Sale Certificate by any of the GHTF countries (U.S, Canada, EU, Japan and Australia) needs to undergo clinical investigation.

We help our customers to get the test license to import the investigational device, chose them right CRO. We compile the data as per format suggested by MDR 2017 and submit to online portal to obtain the permission to perform the clinical investigation.

d. QMS (Medical Devices)

Indian manufacturers need to implement the Quality Management System (QMS) as specified in the Fifth Schedule of Medical Device Rules 2017. Indian QMS requirements are quite similar to Internationally recognized ISO 13485 requirements. we understand the unique needs and manufacturing scenarios of the industry. Our team will help you to create the documentation and provide adequate training. This includes the creation of the SOPs, work instructions, Quality Manuals, VMP’s, Process Validation documentation etc. In the next phase, we provide assistance to implement the system at shop floor and provide the need-based training to make sure that the system is adequately implemented.

e. Wholesale Distribution License (Form 20B and 21B)

Wholesale distribution license is mandatory for sale or distribution. Also, companies holding wholesale distribution license can be the Indian agent to get the import license. We help customers to comply with the requirements and obtain the license.

f. Test License

Small quantity of Class A or Class B or Class C or Class D of medical devices may be manufactured or imported for the purpose of clinical investigations, test, evaluation, examination, demonstration or training. We help the customer to file correct application and get the license.