EU Regulations Archives

December 2023 News Letter

EU Regulations, Patient Guard News, Standards / David Small

As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year. What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective?

The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024

We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.

December 2023 News Letter Read More »

image of a colourful world map - used by patient guard limited on their blog about global medical device and IVD registrations.

Medical Device & IVD registration

Blog, EU Regulations, UK Regulations, USA Regulations / David Small

Medical device registration is an essential part of 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.

Medical Device & IVD registration 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 / David Small

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 / David Small

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 the EU flag - This image is used by Patient Guard to show their EU medical device and IVD consultancy services.

EUDAMED

Blog, EU Regulations, Patient Guard News / David Small

The EU Commission has recently announced that the transition period for completing and implementing EUDAMED has been extended again. The previous target for full functionality was the second quarter of 2024. The new target date for this is now the second quarter of 2027.

EUDAMED 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 / David Small

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 »

EUDAMED: European Database on Medical Devices

Blog, EU Regulations, Quality Management, Standards / David Small

EUDAMED stands for the European Database on Medical Devices. It is a secure, web-based platform established by the EU to collect, store, and disseminate information related to medical devices available in the European market. The primary objective of EUDAMED is to centralize and harmonize data on medical devices, manufacturers, and notified bodies throughout the EU member states.

EUDAMED: European Database on Medical Devices 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 / David Small

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 »

Image shows a Doctor in green scrubs with folded arms - This image is used by Patient Guard to describe its medical device and IVD regulatory and quality assurance related content.

What is the importance of medical device registration?

Blog, Client Questions, EU Regulations, UK Regulations, USA Regulations / David Small

The main reason medical device registration is so important is safety. Ensuring that devices meet medical device regulations means that everyone involved can be confident that they are safe for their intended use. All medical devices are extremely important and can have life-saving capabilities. This means that devices must be working to their full potential.

What is the importance of medical device registration? Read More »

illustration of people with pencils in their hands writing on a large clipboard with the heading regulations on it - used by patient guard limited to discuss the topic of EU regulations and PRRC under article 15 in relation to medical devices and IVDS.

Person Responsible for Regulatory Compliance (PRRC)

Blog, EU Regulations, Patient Guard News / David Small

Person Responsible for Regulatory Compliance (PRRC), is a requirement for medical device and IVD manufacturers and Authorised Representative. Article 15 of regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR), define the legal requirements for a PRRC.

They state that each manufacturer and authorised representative (if applicable) must have at their disposal a PRRC, who has the necessary requisite qualifications and experience for regulatory compliance.

Person Responsible for Regulatory Compliance (PRRC) Read More »

EU Regulations