In a previous post, we were talking about the importance of standardising and normalising the requirements which apply to this sector. Among other things, it involves keeping a technical file which contains all the information pertaining to the product, including a record of the tests that it has passed.
In this post, we’re going to be looking at another essential aspect of medical devices – the compliance assessment.
The market offers a multitude of medical devices which respond to different needs and not all of them are subject to the same requirements. Is it logical to demand the same levels of quality from a hearing aid as from a pacemaker? Product classification is initially concerned with the type of product and groups them into three broad categories depending on their function or intended purpose: general health devices, in vitro diagnostic medical devices (IVDs) and implantable devices. Once this category has been determined, the product must undergo a second level of classification where other criteria are applied depending on the risk that would be involved if the product was faulty in any way, the duration of use, how invasive it is to the human body, the organs that it comes into contact with, the consequences of misdiagnosis, etc. This second classification will determine its class within each of the three categories listed above.
The CE certification process establishes different directives for each category – general medical devices are regulated by directive 93/42/EEC, IVDs are regulated by 98/79/EC and implantable medical devices are regulated by 90/365/EEC.
In accordance with the implementation of these directives, classification of the device also involves the application of its own specific compliance assessment roadmap. This must outline the steps that the manufacturer has to take in order to ensure that their product meets the requirements for the market; the greater the risk, the greater the control requirements. Following this criteria, self-certification is only permitted for products which have been classified as “low risk”. All other products need to be audited and validated by an independent body which is recognised by the health authorities. These organisations are known as Notified Bodies.
These are just a few of the ways in which medical products differ from those made for other industries. Clearly their application has an impact on all those involved in the value chain and, when devices have electronic systems, it also affects EMS companies such as IKOR medical. Our quality management system is certified by AENOR as complying with the ISO 13485:2013 standard, which means that our development and manufacturing processes are guaranteed to meet industry requirements. The product and its manufacturing process are therefore fully traceable and the time-to-market for those products is reduced by streamlining the external auditing and certification processes.
Lastly, what should you do if something goes wrong despite all the above precautions having been taken? Or if the obsolescence of a component means that you have to modify your product after it has been certified? In circumstances like these, manufacturers are obliged to report the incident to the health authorities and take the relevant measures in order to mitigate the issue (regardless of whether it is real or potential) and prevent it from growing. Anticipation (such as actively monitoring components) is the best strategy for avoiding these situations.
Are you thinking of developing or assembling medical devices? Are you looking for an experienced EMS company to help these products take shape? You can count on IKOR because we’re acutely aware that you can’t take chances with health…