Guides and Advice

Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD)

Software as a Medical Device (SaMD) has revolutionised the healthcare industry. From AI helping with medical image scanning to software being used in apps, to help with clinical decision making. Understanding how SaMD is regulated is critical to its success when being launched as a product.

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Medical Device Life Cycle following the Plan, Do, Check, Action model. Used by patient guard to explain medical device design and development life cycle which start with medical device regulations, then standards, then design inputs, then risk management, then design outputs, prototypes, design verification and validation, manufacturing specifications and finally design history, before the cycle starts again at regulations.

Medical Device Design and Development

Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical Devices are required to maintain a Quality Management System, in the USA this is determined under the CFR Title 21 part 820. Within the European Union, it is placed within demonstrating certificated compliance with international standard EN ISO 13485. The USA has recently indicated that they will also use the ISO 13485 standard for the requirements of manufacturers being compliant for QMS purposes. 

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medical device post market surveillance.

Post Market Surveillance – Medical Devices

Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.

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medical device clinical evaluation.

Medical Device Clinical Evaluation

Medical device clinical evaluation is an essential part of regulatory compliance. Clinical Evaluation is a review of all the data that has been generated by the medical device manufacturer; pre-clinical, clinical and post market. The review of this data is performed to assess that the benefits of using the medical device outweigh the risks associated with using the medical device within the devices clinical intended purpose. 

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image of a blue circle with EU written in the middle and yellow stars all around the circle. This image represents the European Union (EU). The imaged is used by Patient Guard limited to highlight their EU Authorised Representative (EUAR) services and also to highlight areas on their website that cover EU regulatory requirements or news.

EU Authorised Representative

The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.

Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.

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Business people shaking hands - Patient Guard uses this image to represent their UK Medical Device Regulatory Services

UK Responsible Person (UKRP) – Medical Devices

The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.

The UKRP acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market.

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