Merriam-Webster defines "essential" as "of the utmost importance: basic, indispensable, necessary."
But is that the only definition of essential?
Product marketing defines essential as getting the product out the door before the competitor.
Regulatory defines essential as getting the product out door without killing someone in the process.
Regulators define essential as welcome to our country with your state-of-the-art medical device but if something goes wrong, we are going to come knocking on your door.
With all these different interpretations of essential, how do manufacturers demonstrate due diligence without getting caught up in the interpretations of others?
Well, with any good story, let's start at the beginning.
"Essential" is the appropriate term for the requirements listed in Annex I of Directive 98/79/EC on in vitro diagnostic medical devices.
The Essential Requirements lists the requirements that a device must demonstrate conformance to in order to affix the CE Mark.
All devices (List A, List B and Non List A/List B) must meet the applicable Essential Requirements. The applicability of an essential requirement is based on the intended use of the IVD.
The essential requirements include General and Design and Manufacturing Requirements.
The general requirements section include requirements that the device meet the performance specifications and will not compromise safety – safety of the patient, safety of the user, safety of property and safety of a huge profit margin. Okay, the last one isn't true but my friends in marketing can be very persuasive.
Anyways, the design and manufacturing section includes the requirements that cover the following areas:
- Chemical and physical properties
- Infection and microbial contamination
- Manufacturing and environmental properties
- Devices which are instruments or apparatus with a measuring function
- Protection against radiation
- Requirements for medical devices connected to or equipped with an energy source
- Protection against mechanical and thermal risks
- Requirements for devices for self-testing
- Information supplied by the manufacturer
Pretty easy. The European Union is telling us the rules and we just need to follow them. However, it's the following part that turns this happy story into a visit to the Black Forest.
A manufacturer is required to gather technical documentation to demonstrate compliance with the Essential Requirements. This is commonly referred to as a technical file. The technical file contains references to the technical documentation that demonstrates conformity to the applicable essential requirement. The technical file contents will be determined by which essential requirements are applicable to the IVD. It would be best to review the Essential Requirements early in the development process to ensure that the applicable essential requirements are addressed and met during the design and manufacture of the IVD.
The essential requirements can be met by providing technical documentation demonstrating compliance to an applicable harmonized standard, applicable standard, guidance or guideline or internal procedure applicable to the essential requirement.
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer. This decision should be based on risk. For high-risk devices, the notified body will probably want to review objective evidence that is based on a known standard. However, for a low risk, self-certification device, internal procedures may be sufficient.
If you decide to use standards, make sure that you keeo an eye on regulatory trends. Odds are that the applicable standards in the beginning of the project will have changed by the end. There is nothing worse than realizing near the end of the product commerciliaztion process that another standard reports into the IVD Directive. Also, keep in mind that as long as you are marketing your product in the European Union, you need to make sure that you are in compliance with the most current version of the standards.
Once you determine the methodology of proving the essential requirements, the next chapter of this saga is the documentation part.
Remember, if it is not documented, it didn’t happen. Therefore, having a checklist to explain how you met the essential requirements is, well, essential.
The following is an example of a table that can be used to help document the essential requirements.
|Essential Requirement||Applicable to the Device? Yes, No or Not Applicable (Explain if not applicable)||Method Used to Demonstrate Conformity||Method Reference||Reference to Supporting Controlled Documents|
|A. GENERAL REQUIREMENTS|
|1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise, directly or indirectly, the clinical condition or the safety of the patients, the safety or health of users or, where applicable, other persons, or the safety of property. Any risks which may be associated with their use must be accept¬able when weighed against the benefits to the patient and be compatible with a high level of protection of health and safety.||Yes||Example Responses include – Recognized Standard Other Standard In House SOP||ISO 13485 – Quality Management System for Medical Devices||ISO 13485 Certificate (Quality Assurance Files)|
Once the essential requirements have been met, you are ready to sell into the European Union. Your device bears the CE Mark demonstrating compliance to the IVD Directive. Your technical file is completed and all your hard work and planning paid off. How’s that for a happy ending?