Your guide to the Medical Device regulatory framework in the CSSD
In this article, we’re going through everything you need to know to navigate the regulatory framework in Europe and Ireland. Even if you are familiar with some of the regulations and standards applicable to CSSD equipment, we want to give you the key to understanding how these came into play and what their name means.
To begin, we’ll cover what is considered a “Medical Device” and we’ll look at the difference between Directives, Regulations and Standards. Then we’ll help you understand the different institutions involved in making these norms to explain the different acronyms. Finally, we’ll list the main regulations applicable to medical devices.
What is a Medical Device?
In the Central Sterile Services Department (CSSD) also called the Hospital Sterile Services Unit (HSSU) most of the equipment is classified as a “Medical Device”. The classification comes from the European Union and comes with its own regulation. The HSE give the following summary of the EU definition “A medical device is a health product or piece of equipment that is used for a medical purpose, which can be used to diagnose, monitor, or treat illness and also, to assist people with physical impairments to improve their quality of life.”
You might feel that an autoclave for example doesn’t fall under this description. However, the spectrum of what is considered a Medical Device is in fact quite wide. Article 2 of the regulation specifies that “products specifically intended for the cleaning, disinfection or sterilisation of medical devices” are also considered as Medical Devices.
Are all equipment used in CSSD considered as “Medical Devices”?
No, not all equipment present in a CSSD is considered as a “medical device”. Some examples are benchtop tables, trolleys, sinks, pass-through hatches or drying cabinets. These would be considered as generic equipment and will fall under health and safety standards in the workplace and HSE guidelines for decontamination.
In general, the equipment needs to have a hygienic design which means easy to clean, non-porous and non-shedding.
For the likes of sinks and fixed worktops, they would be considered as part of the building and will follow once again the HSE guidelines for the build of sterile service. For the sinks, they would still follow a couple of UK standards.
Equipment like computers or drying cabinets are not medical devices but since they have an electronic board, they will fall under the CE mark explained later in this article.
What is the difference between directives, standards and regulations?
Below we are looking at directives, standards and regulations as a state member of the European Union.
A directive is a legal act of the European Union that require all or a selection of member states to achieve a particular set of goals. The directive does not include the means to achieve these goals and each state decides how to ensure compliance as well as what happens in case of a failure to meet the standards. Moreover, the member states can work at their own paste to define the national legal framework to achieve the EU directive goals. In conclusion, there is a level of flexibility with a directive at the state level regarding its application.
A regulation is also a legal act of the European Union, but it overwrites any national laws to be enforced directly and uniformly across all member states. The regulation will be more precise and has more legislative power than a directive. They come into effect directly after being ratified by the EU parliament unless stated otherwise. On that last point, the new Medical Device Regulation (MDR) is a good example. The MDR applies since the 26th of May 2021 however it includes a 4-year transition period to replace the previous Medical Device Directive.
Standards on their side are related to technical specifications. They detail requirements for products, processes, or services in order to be fit for purposes. As opposed to directives and regulations, it’s not the European Commission itself that creates these standards. The European Commission mandates standardisation institutes. Once created they overwrite any conflicting national standards. They also must be transposed into national standards in all European member states by a national standardisation body. Companies must buy the standards to use them and are based on voluntary compliance. These standards help to demonstrate compliance with the EU rules however companies can prove compliance by other means such as legal explanatory documents. If you which to dive more into compliance, this article from the Your Europe official website has everything detailed for you.
Acronyms for directives, regulations and standards explained
Names for directives, regulations and standards use a similar formula. It contains the acronym of the regulatory body, a unique number and the date of the latest amendment (i.e. EU 2017/745, ISO 13485:2016).
Directives and regulations regulatory bodies acronyms
To understand the name of directives and regulations we need to look back at history. The “European Union” (EU) terms date back to 2009 but at first, it was known as the “European Community” in 1957 (EC) and then the “European Economic Community” in 1933 (EEC). Therefore, depending on when the directive or regulation was last updated the name will contain either EC, EEC or EU.
In Ireland, the Health Products Regulatory Authority (HPRA) is the official body responsible for enforcing the directive and regulations and surveying the Irish market.
Standards regulatory bodies acronyms
There are three levels of institutions in standards:
- International Standard: The International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC)
- European Standard: The abbreviation is EN from the German “Europäische Norm” which means “European Norm”
- National Standard: In Ireland, the National Standards Authority of Ireland (NSAI) is responsible for transposing the EN standards into national standards and streamlining any national norms. It uses the acronym I.S. for Irish Standard.
Most ISO standards are adopted by the EU resulting in names including both “ISO” and “EN”. Same story with ISO and IEC which can work conjointly on a specific standard. Then when a standard is harmonised by the national standard body, the name includes all international, European and national acronyms, for example I.S. EN ISO XXXX.
Note that only the national regulatory body (NSAI in Ireland) and its accredited partners – such as EQA – can perform certifications. Certifications are used to demonstrate to regulators that the requirements are met based on the standards. Therefore, a company or a product is not “ISO certified” but “compliant with ISO XXXX”. When certified by a third party, the company receive a pdf certificate and a badge that they can use to display proof of compliance. It works on an audit base and needs to be renewed annually.
Certification badges example with ours at Manepa:
What are the main directives, regulations, standards and guidelines for your CSSD?
Now that you know what the different acronym means we have listed the main directives, regulations and standards applying to most of the equipment in your CSSD and EDU. It’s important to note that most of the equipment will fall under multiple categories and be subject to medical device, machinery and electrical regulations.
Medical Device Directive:
- 93/42 ECC– 14 June 1993 – Historical directive concerning putting medical devices on the market. Certain manufacturers would still display this directive.
- 2007/47/EC – 5 September 2007 – Directive to amend 93/42 ECC above. This directive is still applicable for those who haven’t transitioned to the Medical Device Regulation below.
Medical Device Regulation:
- EU 2017/745 – 5 April 2017 – Repeals Directive 93/42/EEC – Implemented from May 2021 with a 4-year transition roadmap.
Medical Device Standard:
- ISO 13485:2016 – March 2016 – Medical devices — Quality management systems. As mentioned previously, standards are not mandatory however it is the best way to prove compliance with regulations. This standard applies to any entity involved in the life cycle of a medical device, from design to distribution up to servicing.
National guidelines for decontamination:
- HSE Standards and Recommended Practices for Central Decontamination Units – link here.
- HSE Standards and Recommended Practices for Endoscope Reprocessing Units – link here.
- HSE Standards and Recommended Practices for Facility Design and Equipping of Endoscope Decontamination Units – link here.
- HSE Standards and Recommended Practices for Commissioning, Validation and Testing in Endoscope Decontamination Facilities – link here.
Other requirements for medical devices:
All Medical Devices need a Unique Device Identification (UDI), this is a part of the EU medical devices Regulations 2017/745 and 2017/746 (In Vitro Diagnostic Regulation).
All Medical Devices need the CE marking regarding EU safety, health and environmental protection requirements. The marking is mandatory for Medical Devices and for any electronic equipment (plugged into electricity, on battery or simply having a circuit board) which you can also find in a sterile service. It indicates conformity to all relevant EU regulations and directives however it doesn’t indicate conformity to a standard.
Finally, for equipment with electronic components, it is mandatory to comply with Directive 2012/19/EU on waste electrical and electronic equipment (WEEE). This concerns the product design and its disposal to protect the environment and human health by reducing the impact of resource use and waste management.
The European regulatory system is in place to protect the consumer, the environment and ensure best practices for manufacturers, distributors and service providers. Under the European Union, most of the equipment used in sterile service and endoscopy reprocessing services are considered as Medical Devices and need to follow the latest Regulation EU 2017/745 or the directive 93/42 ECC and its amendment 2007/47/EC if not transitioned yet to the regulation. Medical devices and other equipment can also be subject to machinery, electrical and other related directives. On the other hand, standards are available for companies to help prove compliance with the EU rules and regulations. Finally, only an accredited third party provide assessment and certification toward these standards.
We hope you found this article useful and if you have any questions or feedback don’t hesitate to get in touch. At Manepa one of our core values is knowledge, beyond fostering teamwork within our organisation, this also applies to sharing it with our community. Our teams of engineers, sales and support staff have over 200 years of collective knowledge in the healthcare industry, we are always happy to help if you have any challenges regarding decontamination or sterilisation equipment.