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 »
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 »
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.
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 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 »
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 Read More »
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 »
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 »
In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market.
Medical Device Classification EU Read More »
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
Thank you! The checklist is now ready to download.
Complete the form below and receive instant access.
For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
UK Office
Sign up to our newsletter and we’ll deliver news and insights straight to your inbox.
