Welcome to our November 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.
November 2024 News Letter Read More »
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 »
PPE Regulations are in place to ensure the safety, quality, and efficacy of products used to protect the body from hazards. Regulations ensure that personal protective equipment is fit for purpose and conforms to standards.
Personal Protective Equipment (PPE) Regulations Read More »
Cosmetics Regulations are in place to ensure the safety, quality, and efficacy of products used on the skin, hair, and body. Regulations prevent the inclusion of harmful ingredients, protect consumers from potential health risks, and ensure accurate labeling and claims.
Cosmetics Regulations Read More »
Welcome to out October 2024 news letter, here we share the latest medical device regulatory news from the EU, UK and the USA as well as updated or new medical device standards that have been issued.
October 2024 News Letter Read More »
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 »
Great news everyone! Patient Guard is thrilled to bring you fresh updates
through our May 2024 newsletter. We’re super excited to share that
we’ve started offering Training courses – kicking off with our inaugural course on ‘EU Medical Device Regulations 2017/745’.
May 2024 News Letter Read More »
As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.
We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information.
April 2024 – News Letter Read More »
March already! It’s starting to look like spring, the daffodils are out, it’s staying light for longer.
This month we exhibited at the Medical Technology Exhibition at the Coventry Arena, here is our CEO and Founder David Small at our Stand. It was lovely to meet many of our current customers and lots of potential new ones too.
This month we have also been updating our website and our marketing content. To keep UpToDate with the latest regulatory news and content from Patient Guard subscribe to our news letter. You will receive a news letter email with the latest news at the beginning of the month, which is usually 2 to 3 weeks earlier than you will get it on our website news letter.
March 2024 – News Letter Read More »
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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