Standardization is a basic operative strategy for companies in all fields, but especially in highly regulated and critical sectors such as aviation, pharmaceuticals, food, or medical devices. As presented in our previous regulatory posts (EU and US regulation), there are several requirements applicable for medical device companies regarding the definition and implementation of certain processes that are common in the field, such as a quality management system, labeling, or risk management, among others. Standards are guides that help companies comply with these requirements in a uniform way that is shared among organizations worldwide and which facilitates communication, compliance, and operability.
In this article, we will dive into what standards are and which role they play in the medical device industry.
What are the main different legal acts that apply to medical devices?
You may have heard concepts like standard, guidance, regulation, or directive when referring to legal acts, but you don’t exactly know the difference between all of them. Don’t worry, we will decipher the main ones for you now.
- Regulations and directives are binding acts, like laws. They set the requirements that manufacturers need to follow to place devices on the market. These include requirements to ensure that manufacturers design, manufacture, and commercialize safe and effective products.
- Guidance documents are issued by regulatory agencies, governmental bodies, or professional organizations to provide recommendations or best practices on how to interpret and comply with laws, regulations, or standards. Each document clarifies a specific issue that is developed in a more in-depth manner compared to legislative texts.
- Standards are documents established by an accredited organization that provide rules and guidelines for products, processes, services, or systems. Each standard specifies the regions where it applies and most are international. Competent authorities may decide to adopt standards as a way to demonstrate compliance with certain requirements laid in the legislation.
Regulations, Directives, and Guidance for Medical Devices
In the EU, regulations are binding documents in their entirety and are directly applicable in all EU Member States. Unlike regulations, the directives set the objectives that every Member State must meet but provide freedom on how to regulate them. As a result, each state may have different rules on how to enforce the directive. If you remember from our first regulatory piece, the previous legislation on medical devices was a directive, and therefore, national authorities had to develop their own legislations to detail how to achieve what was mandated in the MDD 93/42/EEC Directive. The new legislation, Regulation EU 2017/745, is not a Directive but a Regulation, which means that its contents are directly applicable to all EU Member States. Nevertheless, some aspects are left to be decided at a national level such as languages or single-use reprocessing, and, therefore, national authorities still have some specific legislation in their countries that manufacturers and other operators need to be aware of.
This is similar in the US, where regulations are binding acts in all states although each state may have their specific regulations that establish, for example, requirements related to licensing and establishments. As we presented in our second post, Title 21 of the Code of Federal Regulations (21 CFR) is the applicable legislation for medical devices in all US states.
Regarding guidances, in the EU most of them are endorsed by the Medical Device Coordination Group (MDCG) and present a common understanding of how the MDR and IVDR should be applied in practice. The FDA also provides an extensive list of guidance documents to describe their interpretation of a regulatory issue. It is recommended to follow them to successfully ensure compliance with 21 CFR.
Standards Used in the Medical Device Sector
Following a standard process that is recognized by a regulatory authority, makes it easy for companies to comply with requirements and to easily reinforce their processes. Companies may read the standard and implement their rules into their processes or they can take a step further and obtain a certification demonstrating compliance with said standard.
Normally standards are denominated by using an alphanumeric code consisting of the acronym of the accreditation body (e.g. ISO, IEC), followed by a numeric sequence, particularly in series or sets of related standards (e.g. 60601, 27000), and finishes with the publication date to indicate the version or edition of the standard. ISO 13485:2016 means that the standard was issued by the International Standardization Organization (ISO), 13485 is the code of the standard for medical device companies’ quality management system and 2016 is the date of publication.
An important thing to consider if commercializing in the EU is the existence of the harmonized standards, which are European standards developed by a recognized European Standards Organisation (CEN, CENELEC, or ETSI) that manufacturers, other economic operators, can use to demonstrate compliance with the MDR requirements. For example, EN ISO 13485:2021 is the standard specifically harmonized for compliance with EU regulations and shares the same core requirements with ISO 13485:2016. Although it is not mandatory to follow these standards to demonstrate compliance with the regulatory requirements, and manufacturers may decide to demonstrate compliance otherwise, it is highly advisable to follow them, as they have already been adopted by the regulatory authority as an acceptable approach to fulfill the established requirements (the so-called “presumption of conformity”). In the US there is a similar situation, as the FDA also recognizes standards.
There are a lot of standards that may apply to a medical device company, depending on their activities and products, but some of the most useful ones are:
- ISO 13485:2016 – Medical devices – Quality management systems
- ISO 14971:2019 – Medical devices – Application of risk management to medical devices
- ISO 15223-1:2021 – Medical devices – Symbols to be used with information to be supplied by the manufacturer
- ISO 14155:2020 – Clinical investigation of medical devices for human subjects
- IEC 62304:2006 – Medical device software – Software life cycle processes
- ISO 20417:2021 – Medical devices – Information to be supplied by the manufacturer
- ISO 10993 series – Biological evaluation of medical devices
- IEC 60601 series – Medical electrical equipment
- IEC 81001-5-1:2021 – Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle
We will provide additional information on these standards in upcoming posts. Stay tuned if you’re interested!
Neuroelectrics Certification
Neuroelectrics fulfills its obligations as a manufacturer of medical devices by maintaining a certified quality management system under ISO 13485:2016. All our medical devices comply with a certain set of standards, which has been key to ensuring their regulatory approval before placing them on the market.
You can find in our website our medical devices:
- CE marked devices:
- Enobio
- NG Pistim
- NG Geltrode
- Earclip
- Foretrode
- Drytrode
- Sponstim
- Neoprene Headcap
- Neoprene Headcap Pro
- Neoprene Headband
- 510k cleared devices:
- Enobio Dx
Conclusion
In summary, every medical device company needs to develop its processes by introducing the guidelines defined standards. At Neuroelectrics, we make sure to follow these guidelines to ensure the safety, effectiveness, and compliance of our products. This not only guarantees the well-being of patients but also helps us build a trustworthy reputation within the healthcare community. By doing so, we contribute to enhancing the quality of patient care on a global scale.
References
- Code of Federal Regulations (CFR). URL: https://www.ecfr.gov/current/title-21
- EU 93/42/EEC Directive. URL: https://eur-lex.europa.eu/eli/dir/1993/42
- EU 2017/745 Regulation. URL: http://data.europa.eu/eli/reg/2017/745
- EU harmonized standards. URL: https://single-market-economy.ec.europa.eu/single-market/european-standards/harmonised-standards_en
- FDA guidance documents. URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents
- FDA Database of recognized standards. URL: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
- MDCG guidance. URL: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
