Patient Guard News

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.

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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

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.

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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.

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Patient Guard medical device consultancy lifecycle showing support from idea and concept through design, regulatory strategy, Technical Documentation, Clinical Evaluation, CE marking, market launch and ongoing compliance.

Medical Device Consultancy

Blog, Patient Guard News /

Medical device consultancy helps manufacturers navigate complex regulatory, quality and technical requirements throughout the product lifecycle. From early regulatory strategy and product classification through to Technical Documentation, ISO 13485, clinical evaluation, biological evaluation, validation, CE marking, UKCA compliance and post-market surveillance, the right consultancy partner can reduce risk, avoid costly delays and support successful market access.

Patient Guard provides specialist medical device consultancy services for manufacturers, start-ups, distributors and international companies placing devices on the UK, EU and global markets. Our team supports organisations with practical regulatory and quality assurance guidance designed to help bring safe, compliant and effective medical devices to market.

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