The medical devices industry is one industry that is considered to be highly regulated. ISO certification for the medical devices industry is not to be taken lightly. Failure to comply with a number of regulations may force an organisation to shut down and lose its necessary permits if all goes to worse.

A lot weighs on whether the organisation is involved in manufacturing, distributing, or importing medical devices. There might be other elements which may also impact the level of certification required to work in such an industry. For example, if an organisation dealing with medical device manufacturing uses a laboratory to output data, then additional certifications would be required. These have to be in line with the regulations covering laboratory instrument usage.

When it comes to medical devices, we must consider MDR and IVDR. These two regulations became enforced in May 2012 and May 2022, respectively. The In Vitro Diagnostic Regulation (IVDR) is a European Union (EU) regulation that sets out the requirements for the design, manufacture, and performance of in vitro diagnostic medical devices (IVDs). The Medical Device Regulation (MDR) is another EU regulation that applies to medical devices, including IVDs.

Both the IVDR and MDR are designed to ensure the safety and performance of medical devices in the EU, and both regulations are intended to protect public health. However, each regulation’s specific requirements differ, and medical device manufacturers must comply with the relevant requirements to place their products on the EU market.

Part of the requirements of the MDR is to have a GDP – a good distribution practice. An additional requirement is to have a quality management system; ideally, such quality management system is built on ISO 9001 foundations. Essentially, all medical device companies have to ensure they have a quality management system and get ISO 9001 certification. Apart from that, some companies involved in the medical devices market also choose to get ISO 13485 certified, which is a quality management system specific for companies involved in Medical Devices.

Luke has worked with many clients involved with medical devices – and from his experience, he can confirm that for importers and distributors of medical devices, ISO 9001 will be enough. However, it is also good for manufacturers to go the extra step and get ISO 13485. When it comes to medical devices, we have to ensure that elements such as forward and backward traceability are present.

Moreover, companies must work with reliable suppliers registered on the European Database for Medical Devices for companies operating from Malta. These suppliers must be registered with the Malta Medicines Authority as companies in the medical device industry. Moreover, all companies handling medical devices must have an MDRP – a medical device registered person… Luke is an MDRP and can help you meet all your compliance needs.

Wait no longer and get the necessary ISO certification for the medical devices industry!