What is a notified body – and what makes its work so vital in the healthcare arena?
An organisation that has been designated by an EU member state to assess whether manufacturers’ medical devices meet legislative requirements, a notified body is, as you can well imagine, used extensively in healthcare.
The notified body has always played a vital role – but now more than ever. Why? With advancements in healthcare happening at a much greater rate during the pandemic, the role of notified bodies is as important as ever.
Read on to find out why the increasing workload of notified bodies may mean more job opportunities for you, too.
Ensuring Healthcare Products Are Fit for Purpose and Safe
“A notified body ensures each product [used in the medical industry] – such as a medical devices, PPE and ventilators – is as safe as possible.” Life Science People’s Aaron Smith explains.
On the same level as government bodies, notified bodies can enforce regulations to ensure healthcare products that get to market are fit for purpose but, above all, they’re safe.
“If a product doesn’t meet these regulations,” continues Aaron, “the manufacturer must make the necessary changes before it’s safe to take to market.”
New regulations were announced before Covid-19 emerged, with the Government explaining what they mean for healthcare companies, as of January 2021.
In short, the Medicines and Healthcare products Regulatory Agency (MHRA) will shoulder the responsibilities for the UK medical devices market that are currently undertaken through the EU system, says the Gov.uk site.
The guidance gives information including how to get your device certified; conformity marking your device and registering it with the MHRA.
UK Manufacturers Must ‘Be Ready’ Ahead of the New Regulations
These new regulations aren’t too far off, says Aaron – and UK manufacturers will ‘need to be ready’ before January, says Aaron.
The fact is, he says, notified bodies’ workload has risen hugely – from around 15 to 20%, leading up to 70% to the Medical Device Regulation (MDR) and Invitro Diagnostic Regulation (IVDR).
There will be more audits over the coming months, Aaron suspects – and companies who are seeing significant growth during the pandemic will need to ensure their products meet the regulations.
A notified body will, amongst other critical tasks, carry out an assessment of the manufacturer’s quality system, including design. Assessing the full design dossier relating to each type of product to ensure they meet the requirements, the notified body will also assess the full technical information relating to each product, carrying out appropriate testing of a representative example of production.
What does that mean for those looking for work during the pandemic?
With more and more products to test during the pandemic, there are undoubtedly more opportunities for work – and we’re recruiting for plenty of roles every day, across the breadth of the life sciences industry.
Learn More About Life Science People’s Current Roles…
Want to hear more about the different roles we’re currently recruiting for? Do not hesitate to get in touch with our friendly team here at Life Science People.