Hello!!
Writing after quite some time now!!!
I have been interacting with a friend whose organisation is developing a new medical device. A start up firm, they are keen on weaving in best practices right from start to ensure Regulatory Compliance. So I put together a small document to outline the route they could take in order to achieve that goal. I felt it was worth its while to share it here, considering that it keeps with the spirit of this blog- Quality Assurance for Novices (like me- smile)
Read on, it is pretty generic and does not cover ALL genres of medical devices (Category AP, APG, devices for Oxygen rich environments, Type A devices) but nevertheless a good start.
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Scope
This write-up is intended to give an overview of the logical steps to be followed during the Product Development Cycle of a Medical Device towards compliance to international Regulatory Requirements as dictated by the applicable Harmonized Standards for medical devices.
Target Reader Profile
The target reader is expected to have a minimum knowledge of the Product Development Life-cycle, some exposure to Risk Management in Medical Device Safety, an understanding of Risk Based Device Classification and the overall requirements to compliance.
Steps to Regulatory Compliance
1. Define the “Intended Use” and “Indications for use” of your device
a. The overall device concept
b. User profile, qualification etc.
c. Location of use
d. Max. Duration of use
e. Type of contact with patient
f. Method of powering the device
g. When NOT to use the device
Refer to Note A.2.4.2 and Annexe C of the ISO 14971 standard for more eye openers on this.
This should be a working document, under document control and will form an important part of your Technical Construction File
2. Based on “1” compile complete list of applicable Harmonised standards for medical devices available at
http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/
This compiled list will be under document control and will form an important part of your Technical Construction File
3. Conduct recursive Risk analysis exercises to identify Risks arising from
a. Functional aspects
b. Electrical
c. Mechanical
d. Biocompatibility
e. Usability
f. Ingress protection
g. Software Related Failures(if your device has some form of s/w)
h. Others
Your Risk managent Procedure, Risk Management Plan for a particular family of devices, the actual Risk Management file(identification, quantification, mitigation and requantification, residual risk handling) and a final Consolidated Risk Report for quick perusal will form your risk management file.
All these to be under document control and will form an important part of your Technical Construction File
4. Based on “1”, “2” and “3” and applying the guidelines of MDD document “classification 2_2_4-1part1_07-2001” and classification 2_2_4-1part2_07-2001 Classify your device.
Generate a clear flow-chart/ table showing which rules apply and why and the final Classification.
This classification along with the rationale for classification to be under document control and will form an important part of your Technical Construction File
5. Based on ANSI/AAMI/ISO 10993 guidelines and the characteristics identified in “1” identify the applicable Biocompatibility tests for the “Applied Part”.
a. This document showing identification of applicable Biocompatible tests along with the rationale to be under document control and will form an important part of your Technical Construction File
b. Providing cross Ref. to this document, your “Purchase” document for the applied part should identify that availability of MSDS certificate from the manufacturer of the raw material of the applied part is a REQUIREMENT for accepting the produced applied parts.
6. Classify the type of Applied Part as per IEC 60601-1 definition and classification.(Your NB may perform a test on a EUT to ascertain if your classification is justified)
7. Classify your device according to ISM standards.
"Emissions requirements
Devices shall comply with the relevant requirements of CISPR 11 that contains limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment.
ISM equipment is classified into classes and groups:
Group 1: All ISM equipment in which there is internally generated and used, conductively coupled RF energy necessary for the internal functioning of the equipment.
Group 2: All ISM equipment in which RF energy is internally generated an/or used in the form of electromagnetic radiation for the treatment of material and spark erosion equipment
Class A: Equipment is suitable for use in other than domestic establishments and those connected to the domestic power supply
Class B: Equipment is suitable for use in domestic establishments."
This forms the basis for you to identify the applicable tests for Electrical Safety in compliance to IEC 60601-1-2.
8. Complete the following tables in IEC 60601-1-2 standard.
a. Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME SYSTEMS (Fig. 1 for guidance)
b. Table 2 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for all ME EQUIPMENT and ME SYSTEMS (Fig. 3 for Guidance)
c. Table 3 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (if applicable)
d. Table 4 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING (if applicable)
Such a document with the completed tables will form the “Manufacturer’s Declaration” for the device. This will become
• a part of your final “Information to the User” documents
• The list against which your Testing Agency will perform the EMI/EMC tests.
Evidently, this will have to be under Document Control and becomes part of the Technical construction File via the IFU documents.
9. Similarly identify the applicable mechanical stability tests under IEC 60601-1 – Sec 9
10. Identify
a. The various labeling requirements per IEC 60601-1 Sec 7- specifically those required for safe installation, operation, maintenance, disposal(is any).
b. Identify the applicable symbols per EN 980 standard for medical device labeling.
Ideally there should be a working document showing what are the mandatory markings required for your device, where you intend to affix them, which EN 980 symbol(with Ref No. from the Std.) will be used etc.
This will be under Document control and will form a basis for
• Artwork for the labels
• Inclusion into the IFU to explain the various symbols found on the device to the end user.
And will be a part of your Technical Construction file
11. If your device incorporates some proprietary software, ensure that it is developed as per the ISO 62304 mandates in order to comply with IEC 60601-1-4 requirements.
a. Software Design Requirements Specification
b. Software Verification Plan
c. Software Verification Records
d. Software Validation Plan
e. Validation REcords
These will be under Document control and will be a part of your Technical Construction file
12. While designing the form factor and GUI adhere to the mandates of the IEC 60601-1-6 and maintain a working Usability File covering at a minimum the following.
a. Medical Purpose
b. Patient Population
c. Part of the body or type of tissue applied or interacted with
d. Intended Operator Profile
e. Physical Condition
f. Device Mobility
g. Primary Operating Functions (Critical, Frequently used, sparingly used)
h. Use Cases (what constitutes Pass and Failed use case)
i. Interface Requirements between user and device- GUI elements, alarms, annunciations, labels etc.
j. Safety information to be provided- symbols, labels, messages, warnings etc. On Device, in IFU etc. (ideally with ref. to the Risk management file where these needs have been identified), the symbol reference from the applicable standard etc.
k. Operator- User Interface Requirement Verification Checklist
l. Usability validation plan
m. Records of Usability Validation
These will be under Document control and will be a part of your Technical Construction file.
13. The requirements for Electrical safety, Mechanical safety and Biocompatibility identified under “5”, “6”, “7”, “8”, “9” should go into your DRS with some traceability from the DRS to those documents and if feasible- to the Risk File.
14. The Labeling and IFU requirements should be verified as fulfilled in a Review of the IFU and final Labeling of the device. An IFU validation Plan and associated records will ensure a good IFU quality
15. Clinical Evaluations/tests to prove the efficiency of the device should be performed as per ISO 14155 requirements. There should be
a. A Clinical Evaluation Plan
b. A roadmap of the Execution of such plan
c. Records of the evaluation
d. Final inferences drawn and conclusion of the Evaluations
16. It would be a good practice to populate the “Essential Requirements Checklist under MDD 93/42/EEC and do multiple reviews to ensure all requirements have been met.
17. MOST IMPORTANT- All documents to be under Document controls, dated, reviewed and cleared as Final and Acceptable for Release.
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This exercise would cover a good part of the REgulatory requirements for most regulatory approvals.
Remember this is only the ground work. Your actual design phase will incorporate the requirements you identified through this exercise. But you have the edge that you will not have to recursively repeat your design phase after finding that your design is non compliant as is the case when you do not identify the regulatory requirements early on. This reduces the time to market as also the astronomical costs associated with redegisning.
Do write in with your comments on whether at all you find this article useful. Good Day!!!
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