Regulations and compliance are generally complex subjects. However, they exist for a clear reason: to ensure that quality and safety standards are met and to reduce potential risks. This is particularly critical in the biomedical sector, especially when it comes to the equipment used in laboratories and clinics.
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With numerous regulatory changes in recent years, a level of uncertainty has emerged, resulting in laboratories and clinics unknowingly exposing themselves to unnecessary risk.
Whether responsible for managing a laboratory, conducting research that relies on certified equipment, evaluating purchases as part of a procurement team, or overseeing quality assurance, it is important to understand how to confirm that equipment meets the required standards.
Background
When the United Kingdom was part of the European Union, confirming equipment compliance was relatively straightforward. Manufacturers were required to ensure that biomedical equipment carried a CE mark to be legally sold in Europe.
The presence of this mark indicated that the product met essential safety, health, and environmental protection requirements.
Following Brexit, the UKCA mark was introduced to replace CE marking for products sold in the United Kingdom. A transition period allowed CE-marked products to remain on the market while re-certification was completed. However, this process has proven challenging, and there are current proposals to recognize CE marking indefinitely.
Adding further complexity, the Medical Device Directive transitioned to the Medical Device Regulation in 2021. The MDR was introduced to further improve patient safety by placing increased emphasis on transparency, traceability, and clinical evidence. Manufacturers are now required to meet MDR requirements while continuing to maintain CE marking.
Does all biomedical equipment meet CE or MDR regulations?
In principle, all biomedical equipment should meet CE or MDR requirements. In practice, this is not always the case.
Regulations specify that when a liquid nitrogen cryogenic freezer is supplied for applications in which stored samples are intended to be reintroduced into the human body, it is classified as a medical device and must be certified under the MDD or MDR framework.
MDR certification is more demanding than CE marking and represents specific medical device legislation. Whether demonstrated through CE marking or MDR certification, compliance indicates that equipment meets high standards for safety, health, and environmental protection and is fit for its intended purpose.
Although manufacturers are responsible for certifying their equipment, regulations place responsibility on both the supplier and the end user to confirm compliance. This assumption that certification is solely the manufacturer’s responsibility has allowed non-compliant equipment to enter laboratory environments.
When suppliers fail to disclose non-compliance, laboratory managers and procurement teams may assume certification is in place and proceed with the installation.
If the Medicines and Healthcare products Regulatory Agency (MHRA) conducts an inspection, organizations must be able to justify why uncertified equipment is in use. Failure to do so can result in serious consequences.
The risks non-compliance carries
Using equipment without proper certification means there is no assurance that required safety standards have been met, potentially placing patients at risk.
In addition to safety concerns, non-compliant equipment may result in regulatory failures, delays to clinical trials, rejection by regulatory authorities, wasted research efforts, and, in severe cases, loss of operating licenses or legal action.
For fertility clinics or biobanks, trust is central to service delivery. Any damage to reputation caused by non-compliance can have a significant financial and operational impact.
For these reasons, it is essential to verify CE or MDR compliance for medical devices and for the gases used in biomedical applications.
How Air Products can help
Making informed purchasing decisions and avoiding the risks associated with non-compliance is essential. However, time pressures, limited resources, and insufficient transparency from some manufacturers can make this difficult.
Air Products supports customers in two key ways. Firstly, as a responsible supplier partner, Air Products helps organizations stay informed about evolving UK standards, explains regulatory requirements, and provides guidance to support compliance. This forms part of the consultative support offered.
Secondly, Air Products supplies a range of fully CE-marked and Medical Device-certified equipment, supported by clear documentation, traceability, and assistance with audits and clinical validation. Air Products is also the only industrial gas manufacturer in the United Kingdom that provides MDR-certified liquid nitrogen.
In conclusion
Following Brexit and the transition to MDR, biomedical equipment is now being sold in the United Kingdom without the automatic assurance of CE marking. As a result, it is no longer safe to assume that all equipment meets required compliance standards.
Careful consideration is essential. By taking the time to verify certification and review supporting documentation, laboratories and clinics can significantly reduce regulatory, operational, and patient safety risks.
Acknowledgments
This article was produced using materials originally authored by Kenny Rea at Air Products.
About Air Products PLC
Air Products touch the lives of consumers around the globe in positive ways every day. With approximately 16,000 employees and operations in 50 countries, we serve customers across a wide range of industries from food and beverage to medical, energy, and transportation. We supply a unique portfolio of atmospheric and process gases, equipment, and services.
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