Standards and processes in medical technology for newcomers

"MDR," "MPG," "60601," and "62304": Experienced colleagues constantly throw around these terms when developing medical electrical devices. For someone new to this field, the standards and regulations can quickly become confusing.

In the following article, I would like to give you an overview of the current (as of January 2021) legal and normative framework and briefly list the most important standards and laws so that you, as a newcomer, can get an overview.

Laws, regulations, guidelines

Let’s start with the legal framework; here we have the following important terms: MPG, MDD, MPDG and MDR.

MPG – Medical Devices Act

This law regulates the development, distribution and use of medical devices in Germany and is intended to “ensure the safety, suitability and performance of medical devices as well as the health and necessary protection of patients, users and third parties”.^[1] It complements and is the national implementation of the European directives:
• Directive 93/42/EEC on medical devices (Medical Device Directive – MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (IVDD)
In the course of the transition from MDD and IVDD to MDR and IVDR, it will soon be replaced by the MPDG.

MPDG – Medical Devices Law Implementation Act

The MPDG is intended to gradually replace the MPG from 26 May 2021 and regulates and supplements the national implementation of the MDR in Germany. ^[2]

MDR – Medical Device Regulation, Medical Device Regulation – Regulation (EU) 2017/745

The MDR is the EU’s attempt to standardize the approval and distribution of medical devices in the EU.^[3] There is a lot of information about this on the EU website.^[4] According to current status, the introduction is scheduled to come into force on May 26, 2021, with a transition period until 2024.

An overview of the legal framework and further information can also be found in our article: MDD, MPG and Co.

authorities

Authorities are often involved in the approval of medical devices:

BfArM – Federal Institute for Drugs and Medical Devices

The BfArM is responsible for the approval, improvement of the safety of medicinal products, risk assessment and evaluation of medical devices and the monitoring of the trade in narcotics and precursors.^[5] Incidents are also reported to the BfArM and can be searched for in a database. This can be useful for finding out about common errors in a product group.

FDA – Food and Drug Administration

The FDA is the regulatory authority responsible for medical devices in the United States. The FDA offers numerous guidance documents that should be considered during development and approval.

Product standards

There are two basic safety standards in the field of electrical medical devices:

IEC 60601

IEC 60601-1 is the standard for general requirements for the safety and essential performance of medical electrical devicesThe -1 is the basic standard of the 60601 family of standards, which includes numerous supplementary standards and special specifications. We've already written an article about this family of standards, which I'd like to link to here: IEC 60601-1 – How are basic standards, collateral standards and specific requirements related?

On the blog, you'll find other interesting articles on specific 60601 topics, such as insulation diagrams or EMC requirements. Simply use the search function.

IEC 61010

IEC 61010-1 is the standard for safety requirements for electrical equipment for measurement, control, and laboratory use. Like IEC 60601, it is a family of standards in which the basic standard is supplemented by specific requirements. This standard is listed here because in vitro diagnostic (IVD) medical devices are laboratory devices developed and approved according to this standard.

ISO 10993

ISO 10993 is the standard series for assessing biocompatibility. Biocompatibility means that substances that come into contact with the user or patient do not harm them, meaning they must meet certain requirements for toxicity and allergens.

Process standards

ISO 13485

ISO 13485 specifies requirements for the quality management system of
Organizations “for the design and development, production and installation as well as the maintenance of
Medical Devices”. In the article ISO 13485 – What does it actually say? You can find out more about ISO 13485.

ISO 14971

ISO 14971 describes risk management requirements. The risk management process is a central component of any medical device development. The organization's processes within the framework of ISO 13485 are also assessed for their risks according to ISO 14971. In the article The third edition of ISO 14971 the contents and changes in the current (third) edition are described.

IEC 62304

IEC 62304 addresses software lifecycle processes for medical software. This standard applies to all software in a medical device and sets requirements for documentation and development processes. The requirements arising from IEC 62304 are quite extensive and also affect legacy software, for example. We already have a blog post specifically on this topic: Handling legacy software according to IEC62304 
If you have any questions, please feel free to contact us.

IEC 62366

IEC 62366 specifies requirements for validating the usability of medical devices. To achieve usability, there are also requirements for the process and documentation of the measures taken.

This article provides only a brief overview of the essential standards and terms that anyone new to the development of electrical medical devices will encounter. In addition, there are standards for specific products, markets, and—what is becoming increasingly important—security and IT security. We will certainly write more on these topics in the future.

Please leave a comment or email us if you have any questions or comments about this article. I welcome feedback and sharing experiences.

Sources

[1] https://www.gesetze-im-internet.de/mpg/BJNR196300994.html, as of January 14, 2021↩

[2] https://www.buzer.de/gesetz/13935/b36081.htm, as of January 14, 2021↩

[3] https://lexparency.de/eu/MDR/, as of January 14, 2021↩

[4] https://ec.europa.eu/health/md_sector/overview_en, as of January 14, 2021↩

[5] https://www.bfarm.de/DE/BfArM/_node.html, as of January 14, 2021↩