MDR for e-health apps and digital care

Digital care, e-health, remote care, care apps. Whatever you call it, it's not a trend anymore. In fact, at the time of writing, Q4 2022, the apps category (Health) is the second largest app category in the Google Play and Apple App Store. During the global pandemic, the demand (and pressure) for remote care became much greater. Healthcare authorities have responded en masse to this to relieve the pressure. From a virtual dentist to remote maternity care.

Good control is essential to guarantee the quality of such medical devices and to limit the risks. Since the beginning of 2021, the European Union has introduced new legislation to ensure the quality of software. The regulation for medical devices called: Medical Device Regulation (MDR). This inspection is organized at a European level by means of a CE certificate.

This does not mean that all software developed for healthcare must comply with MDR. There are a number of risk classes that the product can fall into. No MDR is required in the lowest risk class. You can read exactly how this all works in this blog post…

First, things first… what is e-health?

E-health (or previously mentioned terms) is a collective name for all medical software and applications that (remotely) contribute to people's health. This not only increases the quality of care, it can also help to keep healthcare affordable.

MDR for e-health apps and digital healthcare

A good example of e-health is BabyManager. The digital maternity care in the form of a native iOS and Android app. Future and new parents get all the knowledge they need during and after pregnancy through educational videos, courses and week-by-week information. Do they still have a burning question? Maternity care professionals are available 24/7 via chat or video calling. Access to this app is therefore reimbursed by all health insurers in the Netherlands. Because this application falls into the low risk class, no certification is required.

Medical Device Regulation (MDR)

This new legislation has been created to ensure that all medical devices are not only safe, but also show the correct data, handle personal data safely and it is clear how they should be used.

What is the CE certification?

You can distinguish between CE marking and CE certification. You can see the CE marking on many products, which is placed on the product by the manufacturer itself.

“With CE marking, the manufacturer declares that its products have been tested against all applicable EU legislation requiring CE marking and are in compliance with the health, safety, performance and environmental requirements relevant to those products.” – National government https://www.rvo.nl/onderwerpen/eu-wetgeving/ce-markering

The CE certification on medical devices is issued by an independent party that tests the product against all EU legislation with the health, safety, performance and environmental requirements that are relevant. This certification/marking therefore also applies to medical devices, such as a mobile application and/or web app that complies with the MDR. This not only ensures that quality and safety go up. This also ensures the necessary transparency in the digital healthcare / e-health market.

How do I get the CE mark for my software? (4 steps)

The national government also considers e-health software simply as a product. To do this, you must first look into each risk class the software falls into: class I (low risk), class IIa and IIb (medium risk) and class III (high risk). To make it even more complex, a distinction is also made between MDR or In Vitro Diagnostic Regulation (IVDR). The latter only concerns software that conducts research into microorganisms, cells and biomolecules.

Step 1: Determining which risk class applies to your aid.

The first step is to analyze your product. It is possible that your development does not require CE certification at all. The National Government writes enough about this. It has also drawn up an extensive document explaining the risk classes. Please note that this is a legal document of more than 175 pages

https://eur-lex.europa.eu/legal-content/NL/TXT/PDF/?uri=CELEX%3A32017R0745&from=EN

Step 2: Choose Continue

Based on the first step, a number of options are possible:

1. The tool (the software) falls outside the risk class
Your device is not a medical device. So no CE certification is required.

2. The device falls under a low risk class
Your device is considered a medical device. A CE mark is sufficient.

3. The device falls into the medium or high risk class
Your device is considered a medium/high risk medical device. The device must be certified by a notified body.

Step 3: Technical Report

The following steps are only relevant if it concerns a medical device with a low, medium or high risk class. Regardless of the risk class of a product, each manufacturer must comply with the essential safety and performance requirements and technical documentation must be drawn up. This document (QMS 13485) describes everything about the development, implementation and risk management of the application.

Step 4: Register device with European Database on Medical Devices (EUDAMED)

Including the technical documentation, the application for certification or marking can be submitted to the EUDAMED for the EU declaration of conformity. If everything is approved, you will receive the CE mark (low risk) or if you go through the process through a notified body, you will receive the CE certification.

CE Certification is an ongoing process

Even after receipt of a marking or certification, the technical documentation must be up-to-date at all times by means of a Quality Management System. Any changes in the software and incidents must be included here. Does the focus (main functionalities) of the application change completely? Then new certification is necessary.

Technical partner for Medical software and healthcare apps

We prefer to translate complex problems into intuitive solutions that make an impact. Digital healthcare is a perfect example of this. We have had several in the past 8 years care apps developed for Kraamzorg De Waarden, RadboudUMC and UMCG, among others. We also have a software developer role NEN-7510 (Information security for the healthcare sector in the Netherlands).

Do you have the idea to improve care (remotely)? Then please contact us. App developers with a mission. Let's make an impact!