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Medical Devices Regulation – What You Need To Know

Medical Devices Regulation – What You Need To Know

MDR – The Background

The French silicone implant scandal, where fraudulent production of the PIP silicone breast implants highlighted weaknesses in the legal system, damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices. As a result, EU regulations were revised and expanded with the aim of providing a consistently high level of safety & protection for EU citizens.

In 2017, the new Medical Device Regulations (MDR) were introduced – sweeping European legislation designed to ensure that all medical equipment is safe and performs as intended.

From May 2020, all equipment deemed a “medical device” in the EU will need to undergo a conformity assessment or self-assessment to demonstrate it meets legal requirements. The aim of the new legislation is to improve the quality, safety and reliability of medical devices, while also making information more transparent for consumers.

Implementation

The 2017 legislation slipped many people by, but the deadline is looming for when the regulations really take effect and must be fully applied. From May 26 next year, all equipment deemed a “medical device” in the EU will need to undergo a conformity assessment or self-assessment to demonstrate it meets legal requirements. The aim of the new legislation is to improve the quality, safety and reliability of medical devices, while also making information more transparent for consumers. In the wake of various scandals, such as those involving breast implants and metal hip replacements, the definition of “medical devices” has also been significantly expanded in the new Regulations.

Under the new legislation, regulatory authorities will be free to conduct audits at manufacturer’s premises at any time, including unannounced visits. What’s really significant though is that everyone involved in the supply chain will now, have potential responsibility for device defects – that is, any person or company who is placing a product on the market or into service in their own name.

Not all equipment used in a healthcare environment or used by a healthcare professional is a medical device. According to the MHRA, the determining factor for borderline products will be whether or not there is a direct link between the corrective function of the equipment and the individual concerned and that there is a stated medical purpose.

All this means that it’s vital that Occupational Therapists and other health practitioners source equipment from suppliers and manufacturers that are – or will be – MDR-compliant. Ask questions and insist on proof – the all-important CE mark demonstrates that the product has passed the conformity assessment. And don’t assume that Brexit will mean the UK is off the hook: if we do leave the EU, then the MDR regulations and CE marking will be adopted & aligned into UK legislation – the main difference being that we will be considered a 3rd country i.e. outside of the EU27.

MHRA & CE & Hard Brexit

After a hard Brexit, all medical devices, active implantable medical devices, in vitro diagnostic medical devices (IVDs) and custom-made devices will need to be registered with the MHRA prior to being placed on the UK market. Given this is an extension of existing registration requirements, there will be a grace period to allow time for compliance with the new registration process:

  • 4 months: Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, IVD List A
  • 8 months: Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B, Self-test IVDs
  • 12 months: Class I medical devices, Self-certified IVDs, Class A IVDs

MDR & Hard Brexit

In the event of a hard Brexit, the MDR regulations will still be adopted within the UK. However, the UK will be treated as being a “3rd country” – that is, a country outside of the EU27. For European medical devices supplied to the UK, currently, UK based importers & distributors are treated as European distributors, almost as if they were within the same country as the manufacturer. In the event of a hard Brexit, European medical device manufacturers will need an appointed representative (AR) established within the UK to ensure & maintain conformity; communicate with the Secretary of State upon request; provide PMS (Post Market Surveillance); inform the manufacturers about complaints & reports; and terminate the legal relationship with the manufacturer in the event the manufacturer acts contrary to its obligations.

Bakare Beds

The good news is that all of Bakare Beds’ products are CE marked to current standards. Bakare Beds have had a PMS (Post Market Surveillance) system for tracking, tracing & recalling products out in the field and issuing field safety notices, since being awarded the contract to supply Hampshire County Council in 2004. We have been in discussions and have agreed to act as appointed representatives (AR) for our German based manufacturers should a hard Brexit occur.

To put it another way, at Bakare, you’re in safe hands. This includes all our medical beds, which are considered “low risk” Class 1a products under the new legislation, along with other equipment and accessories. Since the Regulations were introduced, we’ve been working closely with all our trusted suppliers to ensure that all our products meet the requirements and are fully compliant. Don’t let next May take you by surprise! Talk to your suppliers now and find out what they’re doing to ensure they’re MDR-compliant. For further information, do check out the European Medicines Agency overview and MHRA guide.

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Testimonials

Hi Louise, Just a quick email to say thank you for organising the bed delivery. It arrived fine and the guys who delivered it were very friendly so please pass on my thanks to them.

Mairi

I just wanted to say thank you for the excellent service that we received from you today, I was really grateful for the quick response we received for a call out, the engineers are also very helpful and professional and certainly represent Bakare in a positive way,

Linda

Thank you so much Jennifer, you have been incredibly helpful and your suggestion of an engineer checking out the problem was spot on. It’s great for Sue that she can have a working bed again and so soon, it’s the best outcome for her. Please pass on my thanks to the engineer for going so quickly and we really appreciate everything you have done.

Patricia

Many thanks Alex and the team for a speedy repair of our bed, much appreciated. Great to know customer care is paramount.

Mrs Brooks

Hi. Spoke to Mr Withers today and visiting to review the bed on Thursday morning. He reported that the bed is fantastic and is really pleased with it. Many Thanks for all your help in arranging this, it has made a significant difference to Mr Withers’ life.

Sharon

I just wanted to email to say thank you for organising the swift delivery of the bed for my client. The client and family are very happy with the product and it being the first hi lo bed I have ordered, I am impressed with it too. Completely meets my client’s needs.

Jenny

Thank you so much for all your helping in getting a bed sort, Jason is now able to come home for Christmas we are so grateful. So thank you for everything.

Rebecca

Dear Mark, Thank you for the speedy attention to my problems yesterday. Thank you so much. YOU’VE CHANGED MY LIFE !!!!

Jerry

Yes of course you made the process very easy to us and incredible customer service so would definitely highly recommend! We will of course wait to here from you on the arrival of the recliner chair to sort delivery.

Gemma