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February 12, 2021 - Medical Devices + Diagnostics, European Union, Regulatory

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 1 of 6)

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The COVID-19 pandemic has significantly accelerated the adoption of digital health and virtual care in Europe, as well as globally. Fueled by technological advancement, including in the space of data analytics and AI, this trend is likely to continue.

As with every health-related product or service, manufacturers of software addressing certain health issues must navigate a complex regulatory landscape. In Europe, prior to being placed on the market, software applications must obtain a CE marking when intended to be used for one or more of the following medical purposes:

  • Diagnosis, prevention, monitoring, treatment, or alleviation of disease;
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
  • Investigation, replacement, or modification of the anatomy or of a physiological process;
  • Providing information by means of in vitro examination of specimens derived from the human body, including blood and tissue donations; or
  • Control or support of conception.

Software also falls under the medical devices regulatory framework and requires CE marking if the software is (i) intended for controlling or influencing the performance of medical devices (e.g., software controlling the dosage of automatically given medication) or (ii) is an “accessory for a medical device” (e.g., software on a smartphone linked wirelessly for data collection to a monitoring medical device).

The relevant framework is currently laid out in the EU Medical Device Directive (93/42/EEC, as amended by Directive 2007/47/EC – “MDD”), as transposed in various national laws of the EU Member States, in Germany, for example, the German Medical Device Act (Medizinproduktegesetz).

On May 26, 2021, the MDD is intended to be replaced by the EU Medical Device Regulation 2017/745 (“MDR”). The MDR will provide for a revised and, in certain areas, significantly stricter regulatory framework not only for medical devices in general but also for medical devices software (“MDSW”) in particular. Other than the MDD, the MDR will apply directly in all EU Member States without requiring transposition into national law.

The MDR was initially intended to come into effect on May 26, 2020. This date was moved to May 26, 2021, to avoid the chance that medical device companies will be burdened with additional requirements amidst the COVID-19 pandemic.

Albeit rumor has it that the EU lawmaker is contemplating a further postponement. Given the time and resources that will be required to comply with the new requirements that lie ahead, it is high time for companies planning to offer new MDSW products or services in the EU to start getting up to speed with the new framework now if they have not already done so.

In this series of consecutive articles, we will give a detailed overview on certain key changes that the new MDR regime will bring about for companies that market stand-alone MDSW in Europe.[1] In our upcoming five articles, we will discuss the following issues in greater detail:

  1. A more detailed approach to the “intended purpose.” The new definition of “intended purpose” covers more devices. This includes MDSW for the purpose of “prediction and prognosis” of diseases and health conditions. Furthermore, companies should be aware of the way the intended purpose is determined, as this requires a consistent approach to labelling, use instructions, and promotional material. (Available 2/19)
  2. Risk class re-categorization. The new risk categorization regime of the MDR introduces a specific rule dedicated to stand-alone MDSW, according to which many stand-alone MDSWs are expected to be categorized as Class IIa and higher. As a result of that, mere self‑certification will no longer suffice, and there may be a need to update technical documentation. There will, however, still be room for categorization in Class I. (Available 2/25)
  3. Additional quality assurance and documentation requirements for MDSW. In contrast to the MDD, the MDR places more emphasis on the entire life cycle of a MDSW. This approach entails new requirements and an increased level of detail to Quality Managements Systems, Clinical Evaluations, and Technical Data, as well as the reinforcement of the post‑market obligations. (Available 3/11)
  4. Introduction of a Unique Device Identification requirement for MDSW. The MDR introduces a more detailed tracking mechanism. The unique device identification (“UDI”) must be used by any MDSW company. It allows the company and authorities to trace individual devices through their supply chain. The intention here is to make recalls fast and efficient if devices have been deemed a safety risk. Moreover, the MDR aims for a more efficient access to information about approved MDSW through the European Databank on Medical Devices (“EUDAMED”). (Available 3/24)
  5. How about Class I MDSW already on the market? MDSW currently classified as a Class I medical device under the MDD, which would be moved into a higher-risk class under the MDR, will only be required to comply with the new rules as of May 26, 2024, if it continues to comply with the requirements of the MDD and there are no significant changes in design and the intended purpose. Guidance on what constitutes significant changes can be found here. Yet, these MDSWs, too, will be subject to the requirements of the MDR relating to market surveillance and post-market surveillance, vigilance, registration of economic operators, and of devices from May 26, 2021. (Available 4/13)

MDSW companies placing or intending to place MDSW on the EU market should be aware of the key changes of the MDR and consider whether these affect their operations in order to ensure a smooth transition from the MDD to the MDR. Read more in our weekly series publications.


[1] Note that this article does not address the In Vitro Diagnostic Regulation (“IVDR”); the interested reader can find information here.