Software as a Medical Device (SaMD) Registration in the European Union (EU) Market

In the European Union (EU), compliance for Software as a Medical Device (SaMD) is governed by the Medical Device Regulation (EU MDR) 2017/745 and the In Vitro Diagnostic Regulation (EU IVDR) 2017/746. Pharma Wizard offers end-to-end regulatory support for SaMDs, ensuring full alignment with EU requirements and enabling a smooth, successful market entry.

Overview

Expertise & Advantages

Performance Evaluation for Medical Devices – Overview

The global Software as a Medical Device (SaMD) market is experiencing rapid growth, driven by increasing demand for remote healthcare services and continuous innovation in digital health technologies. In Europe, the SaMD market is projected to grow at a CAGR of approximately 27.1% between 2021 and 2027. It’s important to note that EU regulations do not use the term “Software as a Medical Device (SaMD).” Instead, the term Medical Device Software (MDSW) is applied, as defined under EU MDR 2017/745 and IVDR 2017/746.

How Does Software Qualify as a Medical Device?

To determine if your software qualifies as an SaMD (or MDSW under EU terms), assess whether it is:

If your software meets these conditions, it may be considered standalone MDSW and subject to MDR or IVDR requirements. If it’s intended to control, drive, or be part of a hardware medical device, it’s not considered standalone and follows different classification rules.

How to Register Your SaMD in the EU

Introducing SaMD into the EU market under MDR or IVDR requires a structured regulatory pathway:

Classification – Determine the risk class based on the intended purpose
Conformity Assessment – Engage a Notified Body (NB) if required (typically for higher-risk classes)
Technical Documentation – Prepare comprehensive files that align with MDR/IVDR Annexes
Clinical Evaluation or Performance Evaluation – Provide evidence of safety, efficacy, and intended performance
Quality Management System (QMS) – Implement and maintain a system compliant with ISO 13485
CE Marking – Affix CE mark post successful conformity assessment
EUDAMED Registration – Register the device in the European Database on Medical Devices
Post-Market Surveillance (PMS) & Vigilance – Monitor safety and performance throughout the product lifecycle
Cybersecurity Compliance – Ensure software meets data protection and security standards

Pharma Wizard helps manufacturers navigate every step of this process—from classification and documentation to CE marking and post-market compliance—ensuring your software meets EU regulatory expectations efficiently and effectively.

FAQS

1. What is an EU MDR/IVDR certificate?

An EU MDR/IVDR certificate is an official document issued by a Notified Body (NB) following a successful conformity assessment under the European Union Medical Device Regulation (EU MDR 2017/745) or the In Vitro Diagnostic Regulation (IVDR 2017/746).
This certificate confirms that the medical or in-vitro diagnostic device complies with the required safety, performance, and quality standards set by EU regulations. It is a mandatory requirement for legally placing such devices on the EU market.

2. What are Class I, II and III for SaMD in the EU?

In the EU, medical devices are classified into four (04) risk classes: Class I, Class IIa, Class IIb, and Class III. Class I represents devices with the lowest risk, and Class III includes devices with the highest risk. The classification considers factors such as the invasiveness of the device, the duration of use, the part of the body affected, and the potential risks associated with the device’s technical design and manufacture.
In the same manner, SaMD is also classified according to the risk it poses to patients and users, ranging from low risk (Class I) to high risk (Class III).

3. What is the difference between Medical Device Software (MDSW), Software as a Medical Device (SaMD), and Software in a Medical Device (SiMD)?

The term “Software as a Medical Device (SaMD)” is applied when the software is designed for one (01) or more medical purposes, independently performing these functions without being an integral part of a hardware medical device. On the other hand, “Software in a Medical Device (SiMD)” is utilized when software is integrated into medical equipment, known as embedded software or firmware.

It is crucial to emphasize that the EU regulations do not employ the term “Software as a Medical Device.” Instead, they utilize the term “Medical Device Software,” abbreviated as MDSW.

“Medical Device Software (MDSW)” refers to software intended for use, either on its own or in combination, for a purpose outlined in the definition of a “Medical Device” as per the EU MDR 2017/745 and EU IVDR 2017/746.

4. How long does it take to get a SaMD approved?

The time it takes to get an SaMD approved in the EU can vary significantly based on several factors. The key determinants include the device’s classification, complexity, conformity assessment route, the involvement of an NB, and the efficiency of the Regulatory submission process.

SaMD Registration in the other markets (EU/Australia/Korea) for Medical Devices

Comprehensive EU MDR/IVDR Regulatory strategy for SaMDs.
Regulatory and market intelligence support.
Product classification and registration services for SaMDs.
Regulatory support for SaMD product development documents.
Consultation services on SaMD clinical evaluation studies.
Post-approval change management.
EAR/UKRP/CH-Rep services.

Successful submissions for various classes of SaMDs.
Dedicated and expert personnel to provide Regulatory support.
On-time submission of deliverables.
Local affiliate access to meet Health Authority (HA) challenges and language-specific requirements.
In-country or Legal Representative (LR) support, with a cost-effective model.
Regulatory resource management/staff augmentation services.

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