Essential Principles for Safety and Performance of Medical Devices (Part 1)

In this guide, we will be sharing with you the basic overview of essential principles (also known as essential requirements in some countries) - what are they and why it is important to ensure that your medical devices meet these requirements.

 

Background

A product owner of a medical device is expected to design and manufacture a product that is safe and performs as intended. For a medical device to be supplied in the market, the essential principles of safety and performance for the medical device must be met. 

Different countries might have slightly different versions of essential principle checklist. For this walk-through, we will use the version provided by Singapore HSA, GN - 16 Essential Principle Checklist Template. You can download it here .

There are seven general requirements of safety and performance that apply to all medical devices products (including in vitro diagnostic medical devices). There are a further eleven design and manufacturing requirements, in which depending on the nature of the medical device, only those relevant to the device needs to be shown compliance.

As this could end up with a very lengthy discussion, we have decided to split them into two parts. For Part 1, we will discuss the first seven general requirements that will affect all medical devices.

 
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Roles of Standards In Meeting Essential Principles Of Safety And Performance

A standard is a document that is established by consensus and approved by a recognised body. It usually provides information based on feedback and best practices by experts from the industry, regulatory bodies and other international organisations, with the objective to provide consistencies for companies of similar industries and/or products.

Standards are drawn up at international, regional and national level.  International standard should be used whenever possible such as the ones developed by International Organisation for Standardisation (ISO) and International Electrotechnical Commission (IEC).

Compliance with applicable medical device standards is voluntary, but it is one way to establish compliance with essential principles and we would strongly encourage that!

Briefly, there are three types of standards for your consideration and will usually adopt several standards from each categories based on the type of medical devices.

Basic Standard (also known as horizontal standard)

Standard that indicates fundamental principles and requirements with regards to general safety and performance applicable to all kinds of products/processes. Examples are such as ISO 13485 (QMS) and ISO 14971 (risk management) for medical device companies.

Group Standard (also known as semi-horizontal standard)

Standard that indicates aspects applicable to families of similar products/ processes. Some examples are ISO 11135 (concerning sterile medical devices) and ISO 23640 (stability of IVD reagents).

Product standard (also known as vertical standard)

Standard that indicates necessary safety and performance aspects of specific products /processes, such as EN ISO 15197 used for self-testing blood glucose monitoring systems.


The Seven General Requirements

1- Use of medical devices not to compromise health and safety

health

Medical devices should be designed and manufactured in such a way that, they will not compromise the clinical conditions or safety of the patients, or the safety of users during proper usage.  Any risk associated with the use of the device should be acceptable risks when weighed against the intended benefit to the patient and should be compatible with a high level of protection of health and safety.


2- Design and construction of medical devices to conform with safety principles

The solutions for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state-of-the-art technology. When risk reduction is required, the product owner should control the risk(s) so that the residual risk(s) associated with each hazard is judged acceptable.

The following principles (priority order) listed should be applied:

hazard/risk
  • identify hazards and estimate the associated risks arising from the intended use and foreseeable misuse,
  • eliminate risks as far as reasonably practicable through inherently safe design and manufacture,
  • reduce the remaining risks as far as is reasonably practicable by taking adequate protection measures, including alarms,
  • inform users of any residual risks.

 

3 - Medical devices to be suitable for intended purpose

Devices must perform in the way intended by the product owner. They must also be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device.

 

4- Long-term safety

A medical device must be designed and produced in a way that ensures the characteristics and performances mentioned in clauses 1, 2 and 3 are not adversely affected when:

  • Device is used within its expected lifetime,
  • Device is subjected to stress that can occur during normal condition of use,
  • Device is properly calibrated and maintained in accordance to product owner’s instructions.

 

5- Medical devices not to be adversely affected by transport or storage

long-haul flight

The devices should be designed, manufactured and packed in such a way that their characteristics and performances as intended, will not be adversely affected by transport and storage conditions (for example, fluctuations of temperature and humidity during a long-haul flight), when the instructions and information provided by the product owner are followed.

 

benefits outweigh side effects

6- Benefits of medical devices to outweigh any undesirable effects

The benefits must outweigh any undesirable side effects for the performances intended.

 

7- Clinical evaluation to be conducted

Every medical device requires clinical evidence to demonstrate that the device complies with the applicable provisions of the essential principles. A clinical evaluation is usually performed.


SUMMARY

documents and records

All in all, complying with these seven requirements is not straightforward but it has to be done. Product owners have to ensure their products are safe and effective as intended. That is why building in a QMS based on ISO 13485 and US FDA requirements (if you are selling in the US) earlier on in your product development phase is important.

Product owners shall ensure their teams have the following procedures well setup:

  • Design & Development procedure (Clause 7.3 of ISO 13485) or Design Control (FDA 21 CFR 820.30), to include verification and validation procedures, testing protocols and reports, operating and servicing manuals, product labels, clinical evaluation and etc (drafted using applicable standards).
  • Design Change (Clause 7.3.7 of ISO 13485) procedure or Change Control (FDA 21 CFR 820.30) to ensure that the safety and performance of device are not adversely impacted when changes are made to the design of the product.
  • Risk Management (ISO 14971) to analyse hazardous situation, harm and mitigation methods to reduce overall risks of medical devices. Benefits of features should outweigh the harm.
  • Control of Documents and Records where the structure ensures that SOPs, Work Instructions, Protocols and any other documents and records are reviewed, approved and stored for the required duration within the company.

 

When you have these processes built in place within the company, complying with these seven requirements is definitely achievable. In the next article, we will discuss the other eleven essential principles which are related to the design and manufacturing of your devices. Stay tune for it!

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