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BSI Blog

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics sidebar.

What are the differences between Market Surveillance, Post-market Surveillance and Vigilance?

Regulations for medical devices have distinct terms for oversight of devices on the market

One area that has been changed substantially in the Medical Devices Regulations (MDR) and In Vitro Diagnostic Medical Devices Regulations (IVDR) is the oversight by manufacturers and competent authorities of devices on the market.  The Regulations use the terms market surveillance, post-market surveillance (PMS) and vigilance.  The differences between these terms are not always understood.

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The Rise and Risks of the "Internet of Things"

Internet of Things (IoT) is a phrase which seems to be cropping up more and more in conversation these days, quite the hot topic - and often when it does, I find it’s accompanied by looks of confusion.

What does it really mean?

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Using voluntary, consensus standards to support medical devices regulations

Developments on both sides of the Atlantic in the use of standards

With its work plan for implementing The 21st Century Cures Act, the US FDA has introduced changes in its programme to recognise standards in support of medical devices regulation. Manufacturers can submit a declaration of conformity to a recognised standard to facilitate the review process to clear their devices. The FDA has recognised more than 1,200 standards developed nationally within the USA or internationally by ISO and IEC. 

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Motorbike protective clothing and the PPE Directive

As an avid motorcyclist I speak from experience when I say, “if you do ride a motorcycle there is a reasonable chance you will fall at some point in your riding career.” The reasons why and the resulting outcomes of a fall will vary greatly but wearing the correct protective clothing may help to reduce potential injuries that follow.

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Why it’s important to choose the correct type of equestrian helmet

This blog has been created to help both consumers understand why it’s important to choose the correct type of equestrian helmet, and for manufacturers to understand the significance of the BSI Kitemark logo.

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Have you identified your person responsible for regulatory compliance?

Medical device and IVD regulations have specific responsibilities for this new role at manufacturers and Authorised Representatives

Article 15 of both the Medical Device Regulations and the In Vitro Medical Device Regulations have significant new requirements for appointing a ‘person responsible for regulatory compliance’. Manufacturers and Authorised Representatives (AR) for both medical devices and IVDs have to identify at least one such person. This person responsible for regulatory compliance has to meet minimum requirements for qualification and experience.

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Functional Safety and why it’s important in today’s environment.

There is an inherent risk associated with every activity that we undertake on a daily basis, for me examples of these could be walking to work, working in the laboratory, going shopping, even sitting here in the office writing this post at my desk.

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Top tips for managing your PPE transition

21 April 2018 is a very important date for the European PPE industry; the PPE Directive 89/686/EEC is repealed with effect from that date and the PPE Regulation (EU) 2016/425 applies. This starts the biggest regulatory process change for over 20 years, that manufacturers need to follow before they can place Personal Protective Equipment onto the European market.

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Changes in the Medical Devices Regulation affect drug delivery devices

The Medical Devices Regulation introduces significant changes in approval process under the Medicinal Products Directive

Article 117 of the Medical Devices Regulation (MDR) (Regulation (EU) 2017/745) amends the Directive on medicinal products for human use (MPD) (Directive 2001/83/EC). This will significantly affect pharmaceutical manufacturers supplying drug delivery devices in combination with their medicinal products (such as pre-filled syringes). 

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Green potatoes are good?

Green potatoes aren’t normally considered a safe or healthy choice. But when the green refers to the process of how they’re grown, processed and transported, the greener the better.

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For how long will you need certificates of conformity to the Directives for medical devices?

Knowing the dates of validity for certificates of conformity is critical in transition planning

An earlier blog post referred to the continued validity of certificates issued under existing Directives after the end of the transition periods for the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The transition provisions in Article 120 of the MDR and Article 110 of the IVDR need careful consideration. 

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Is your emergency lighting fit for purpose?

If you take a look around as you go about your day to day business, you’ll notice just how often you’ll see examples of emergency lighting without even knowing it’s there..  But where does emergency lighting come into play and why is it important? 

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Single audit program for medical device QMS audits taking off

Manufacturer participation driven by requirement to use audit program for Canada from 2019 

While the audit duration for an MDSAP audit is longer than that for a single jurisdiction, the benefit should be a reduction in the number of separate audits that take place. Consequently, an individual regulator should have fewer audits to perform and a manufacturer experience less time being audited in aggregate. 

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5 key steps for a successful transition

Whether you are an existing BSI client or certified with another certification body, BSI can help you transition quickly and effectively to the new standard.  

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Are your medical garments protecting the wearer?

Compliance of protective garments with the Medical Devices Directive (MDD) 93/42/EEC or the Personal Protective Equipment (PPE) Directive 89/686/EEC was a choice between the two when the Directives first came into force. You would normally pick which one to comply with, based on the garments primary use. This changed completely when the MDD was amended in 2007 (2007/47/EC).

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Sterilization standardization moves into new areas

ISO TC 198 – Sterilization of health care products – starts two significant new projects

ISO TC 198, Sterilization of health care products, met in Minneapolis in the last week of April. As well as progressing with a number of new editions of standards in its portfolio, such as those for moist heat, ethylene oxide and radiation sterilization, the Committee initiated work in two new areas.

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Top tips for a safer sizzle

Anybody walking round a UK supermarket last weekend would have noticed the tell-tale signs of the first weekend of really good weather of the year, as out came the displays of barbecue food, as the nation brought their barbecues out of winter storage and prepared to fire them up to enjoy alfresco dining.  It struck me that this would be a good time to write a short piece on barbecue safety

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The Gas Appliances Regulation & “State of the art”

In this blog post, I am turning my attention to a particular phrase that seems to be causing an unparalleled level of angst in the community – “the state of the art”.

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Top considerations for organizations in the built environment sector

BSI’s new Head of Training, Laura Melvin tells us what she considers to be the top considerations for organizations in the built environment sector and what her plans are for 2017.

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Medical devices regulations hit the press

Publication in Official Journal sets clock for implementation

Following positive votes in the European Council and Parliament, the Medical Devices Regulation (MDR) - Regulation (EU) 2017/745 - and In Vitro Diagnostic Medical Devices Regulation (IVDR) - Regulation (EU) 2017/746 - were published in the Official Journal of the European Union on 5th May 2017. 

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Can BSI test or certify my product?

You may have noticed the BSI Kitemark on man hole covers, fire extinguishers and even in your home on things such as plug sockets and your own front door – but what products do we actually test here at BSI?

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