Guides and Advice

Road map relating to the extension introduced by the EU commission for the medical device regulations EU 2017/745. This road map details the new dates inline with when medical device classification types need to be in compliance with the regulation

MDR Article 120

Blog, EU Regulations, Guides and Advice, Patient Guard News, Standards /

In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we’ll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance.

MDR Article 120 Read More »

The risk management of medical devices following ISO 14971

ISO 14971 and the Risk Management of Medical Devices

Blog, EU Regulations, Guides and Advice, Standards, UK Regulations, USA Regulations /

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.

ISO 14971 and the Risk Management of Medical Devices Read More »

A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations /

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.

What is ISO 13485? Read More »

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

Blog, Guides and Advice, Medical Device Pre-launch /

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. 

Medical Device Design and Development Read More »

Image of a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (EU 2017/745).

How to Structure a Medical Device Technical File

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, UK Regulations /

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.

How to Structure a Medical Device Technical File Read More »

medical device post market surveillance.

Post Market Surveillance – Medical Devices

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Quality Management, UK Regulations /

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.

Post Market Surveillance – Medical Devices Read More »

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

Blog, EU Regulations, Guides and Advice, Patient Guard News /

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.

EU Authorised Representative Read More »

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

UK Responsible Person (UKRP) – Medical Devices

Blog, Guides and Advice, Patient Guard News, UK Regulations /

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.

UK Responsible Person (UKRP) – Medical Devices Read More »

IVD regulatory consultancy offered by Patient Guard in relation to the IVDR 2017/745

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746

Blog, EU Regulations, Guides and Advice /

In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.

In Vitro Diagnostic Regulations (IVDR) – EU 2017/746 Read More »

Blood Pressure Cuff, scissors, syringe, stethoscope placed on a white background - Represents medical devices - image used by patient guard to represent subjects relating to medical device and IVD regulatory affairs and Quality Assurance.

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations /

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run? Read More »

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