What is an MDEL? And why does your PPE supplier need one?
Throughout 2020, employee safety has been front-of-mind like never before. Society is working to balance the need to keep the economy moving, while considering how to keep workers safe, healthy, and comfortable.
For most North American businesses, this means the implementation of mask wearing. In every industry, especially those that previously had few safety concerns beyond fire exits, employers have had to source safe, trustworthy suppliers for personal protective equipment (PPE).
What is an MDEL?
In Canada, “if you sell or import any class of medical devices...you must apply for and maintain” a Medical Device Establishment License (MDEL).
Acquiring a Canadian MDEL is a multi-step process that requires suppliers to invest time, money, and knowledge. The purpose of medical licensing is to protect consumers by guaranteeing the safety claims of medical materials including PPE.
So, how exactly does an MDEL translate to safety? And why does your PPE supplier need to have one?
Medical products- imported or manufactured- in Canada must “be designed and manufactured to be safe” and must take reasonable measures to identify and reduce or eliminate any risks inherent to the device.
A supplier (manufacturer or importer) of medical devices must “keep objective evidence to establish that the medical device meets” applicable requirements. The supplier must also submit reports that support their safety and effectiveness claims. Licensed suppliers are subject to audits (randomly if the regulatory body is not satisfied and annually as part of an Annual License Review) to ensure that they maintain these standards.
Therefore, an MDEL means that a supplier has satisfied the Government of Canada’s regulations and their products are considered safe.
Another reason that MDELs help to guarantee safety is the ability of licensed suppliers to recall their products. To have an MDEL, businesses must maintain distribution records for each device sold, including “enough information to allow a complete and rapid withdrawal of any medical device from the market”.
In addition to providing evidence of safety, MDELs also suggest a certain level of trustworthiness.
Consumers cannot be expected to be experts in everything they purchase. This is especially true in the time since COVID, with non-medical companies requiring appropriate, medical-grade PPE.
As stated above, to have an MDEL, suppliers must have detailed, documented knowledge about their product offerings. Knowing that their supplier has adequate knowledge about the safety and effectiveness of products should give consumers confidence when purchasing.
Despite the best intentions of regulatory bodies, there is PPE on the market that is not supplied by established medical suppliers. That is why it is paramount for employers and purchasers to ensure that their PPE purchases come from suppliers with MDELs- to effectively protect those they have a duty of care to.
Compliance at Stepscan
Since 2015, Stepscan has been a registered medical device manufacturer and distributor with Health Canada and the USFDA, and is recognized by Australia's TGA.