How to conduct risk Analysis as per ISO 14971:2012

All medical device companies must establish as a first and foremost step, a risk management process in compliance to the International Standard ISO 14971:2012. This is  mandatory requirement for technical file submission as part of CE marking. First and foremost a plan needs to be determined and implemented where the manufacturer needs to identify the known or foreseeable hazards, and estimate the risks for each hazardous situation.

The three important steps involved in the risk management are:

1. Risk Analysis
2. Risk Evaluation
3. Risk Control

There are several techniques that can be utilized to conduct a risk analysis, a few of which being Fault tree analysis, Prelimiary hazard analysis, Failure mode and effect analysis (FMEA) among others.

The author recommends you to Contact her for further information and expert knowledge and advice on Medical devices CE marking. Contact jeyarajesh@accelregulatory.com

Medical Device Labeling

21 QSR 820.120 lies down a set of regulations for device labeling. Every manufacturer should establish and maintain a procedure to control labeling activities.

The procedure should include:

1. Labels should be printed and applied to remain legible and affixed under appropriate stages
2. Labels should be inspected by a designated individual for accuracy prior to release.
3. Labels should be stored appropriately to prevent mix-ups and provide proper identification
4. Labeling operations should be controlled to prevent mix-ups.
5. Control Numbers help in the traceability of the device throughout its lifecycle.

EN 980:2008 is the gold standard for the symbols used in the labeling of devices.

The author recommends you to Contact her  for further information and expert knowledge on your labeling requirements. Contact jeyarajesh@accelregulatory.com

Guidance for Manufacturers of class I medical Devices

Manufacturers or their Authorised representative who intend to place Class I medical devices in the market should follow the below listed steps:

1. Confirm the product as a medical device
2. Confirm if the product is a class I medical device
3. Follow the below set of procedures prior to placement of device in the market

3a- Meet the essential requirements

3b-Prepare technical File

3c- Request Notified body intervention in cases where the device is supplied sterile or has a measuring function

3d – Prepare Instructions for use and labeling

4. Draft the EC Declaration of Conformity
5. CE marking to be affixed
6. Notify the Competent Authorities
7. Review experience gained from the Post market Surveillance

The technical documentation should cover the Description, Final Product documentation, Packaging and labeling , Design verification, Risk Management, Compliance with the essential requirements and harmonized standards, Clinical evaluation  and manufacturing records.

The author recommends you to Contact her for further information and expert knowledge and advice on Medical devices CE marking. Contact me at jeyarajesh@accelregulatory.com

Sterilization- What documents need to be included in the technical file for CE marking?

Sterilization is a critical process which is monitored and reviewed during the CE marking with great care by the Notified Body due to its underlying significance. In case of terminally sterilized devices the below set of documents need to be submitted as a part of the technical file:

1. Brief description on installation qualification and validation summary with an assurance of a SAL of 10-6.
2. Process validation report with a physical performance qualification and microbiological performance qualification.
3. Load and sterilizer and cycle description should be provided.
4. Related information for all the different methods and compliance to standards should be demonstrated- Ethylene oxide, Moist Heat, Irradiation,
5. Description of routine monitoring should also be provided.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jeyadevirajesh@gmail.com

What Basic Information should your labels carry?

The labeling of medical devices should follow the Harmonised standard EN 980:2008. There are certain basic information that the labels should carry for compliance. These are

1. Manufacturer related data such as Company Name and address along with the Manufacturer symbol
2. Authorised representative name and address along with the symbol.
3. The Brand name of the product along with its generic name
4. All labels should be controlled with specific numbers mentioned on them
5. Symbols specific for temperature and storage conditions
6. Symbols related to the sterility- If provided sterile or not, Resterilization, type of sterilization employed should be mentioned.
7. For electrical Active devices, The power, wattage along with units, applied part symbols should be provided.

Al manufacturers should go through in detail the standard and determine which symbols are found appropriate and place it on the label. A description of the symbols used should be provided in the instructions for use. These labels should be provided as an integral part of the technical file for CE marking.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jeyarajesh@accelregulatory.com

How to demonstrate Equivalence as a part of the Clinical evaluation for MEDDEV 2.7/1 Revision 4

The updated MEDDEV Guidance 2.7/1 Rev 4 lays more emphasis on the choice and criteria for determination of equivalence as a part of the clinical evaluation report.

Clinical, Technical and biological characteristics of the device shall be taken into consideration. It is emphasized that only one equivalent device shall be considered finally and all the three characteristics should be fulfilled for its equivalence. There should be no significant difference in the performance and safety of the device and all differences should be fully disclosed and explained in detail why it does not affect the clinical performance of the device under evaluation. Similarly there should be a detailed evaluation of biological and technical characteristic. The equivalent device should be CE marked medical device used in accordance to the intended purpose as documented in the IFU.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jeyadevirajesh@gmail.com

Medical Device classification as per USFDA

The method and criteria for classification of medical device according to the USFDA differs from the European Medical device directive. The three classes under which medical devices fall into are:

1. Class I general Controls – With/Without exemptions.
2. Class II General Controls and Special controls- With/Without exemptions.
3. Class III General Controls and Pre-market Approval (PMA)

In case of devices that fall into class I or class II and ot exempt then these type of devices require a 510K. Usually all class III devices fall into the PMA category , unless it is a pre amendment devices and 510k would suffice.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices FDA 510K Submission. Contact jeyadevirajesh@gmail.com

Major changes in the new MEDDEV 2.7/1 for clinical evaluation

The MEDDEV 2.7/1 Revision 4 was issued in June 2016 which replaces its 2009 version. It is longer and more detailed in the steps and analysis required to conduct a clinical evaluation. Since this is a guidance document there is no implementation date or period.

The current MEDDEV guidance is more detailed on how manufacturers should conduct a clinical evaluation and a thorough detailed analyis and information needed in each of the stages of the clinical evaluation. This guidance document lays emphasis on the scoping and planning stage of the clinical evaluation and gives more detailed information on the evaluator. In addition to these, a detailed information is provided on how to conduct a literature search and determining an equivalent device. This guidance document narrows down the choice and implementation of equivalence determination.  Thus it is necessary manufacturers need to review the guidance file in detail and take steps for its implementation.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking. Contact jeyadevirajesh@gmail.com

New FDA regulation on Biocompatibility based on risk

FDA has come up with a new regulation for risk based approach to biocompatibility wherein specific steps for implementation have been listed which needs to be included in the 510k submission.

These are that the finished devices should undergo a complete risk assessment. This risk assessment should cover the device materials, processing and various manufacturing methods that are involved. Potential risks due to physical device characteristics and processing methods that pose a risk to the patient and user should be included in addition to the chemical toxicity.

All existing literature, standards, clinical and preclinical data should be identified and reviewed that can be utilized to ascertain risk mitigation in order to avoid additional testing. Risk assessment files should be submitted in the beginning of the biocompatibility sections with clear links between the risk mitigation and tests done needs to be submitted. Evaluation methods needs to be well documented for review by FDA

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking and USFDA. Contact jeyadevirajesh@gmail.com

510k Exempt devices

There are certain Medical devices that do not require review from FDA prior to being marketed. These devices are considered to be “510(k) Exempt”. These devices are generally low risk, Class I devices and a few class II devices too. These do not require a 510k submission to ascertain their safety and effectiveness. These devices are exempt from 510K submission but are not exempt from the general controls applicable for these devices.

The manufacturers of these medical devices need to make sure they are registered annually through the FURLS website for Establishment registration. These devices must be

• be suitable for their intended use
• be adequately packaged and properly labeled
• have establishment registration and device listing forms on file with FDA
• be manufactured under a quality system (with the exception of a small number of class I devices that are subject only to complaint files and general recordkeeping requirements.

The author recommends you to Contact I 3 Consulting for further information and expert knowledge and advice on Medical devices CE marking and USFDA. Contact jeyadevirajesh@gmail.com