Patient Guard


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ISO 14971 and the Risk Management of Medical Devices

In the world of medical devices, ensuring both safety and compliance with industry standards is paramount. One such crucial standard is ISO 14971, a guideline that outlines the application of risk management to medical devices. In this blog post, we will delve into the significance of ISO 14971 in medical device compliance and explore how tools like Patient Guard can aid in achieving and maintaining compliance with this essential standard.

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Image shows a person writing on a chalk board in white chalk with the words " A Guide to ISO 13485" - Patient Guard uses this image to describe medical device and IVD regulatory and quality assurance related content.

What is ISO 13485?

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

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Is Your Product a Medical Device?

In the rapidly evolving landscape of product development, especially within the health and wellness sector, it’s crucial for developers and manufacturers to understand the regulatory implications of their innovations. One burning question that often arises is, “Is my product a medical device?” The classification of a product as a medical device carries significant regulatory and legal implications, impacting market access, safety standards, and compliance requirements. In this blog, we’ll explore the criteria that determine whether a product falls into the medical device category and shed light on the importance of regulatory compliance in this complex field.

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Medical Device & IVD registration

Commercialising your medical device or IVD first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies. 

Depending on where you plan to sell your device(s), successful registration may involve a substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

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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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CE Marking Medical Devices

The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.

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How to Structure a Medical Device Technical File

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of  medical device class.

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The EU Authorised Representative – Medical Devices, how the role has changed since the introduction of the MDR & IVDR

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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UK Responsible Person – Medical Devices

Manufacturers who are not registered businesses in the UK but wish to place medical devices or In Vitro Diagnostics (IVDs) on the UK market, are not allowed to do so without having in place an agreement with a UK registered organisation. This organisation is the UK Responsible Person, and represents and registers the manufacturers medical devices and IVDs with the Medicines & Healthcare products Regulatory Agency (MHRA). 

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