Medical Devices

Medical Device legislation is the regulatory framework for all Medical Devices; including Examination Gloves.

Medical Device Regulation (MDR) EU 2017/745

The Medical Device Regulation (EU) 2017/745 is a new regulation, which replaced the Medical Devices Directive, 93/75/EEC, as well as the Implantable Medical Device Directive, in Europe, entering law on the 26^th May 2021. This law is also effective in Northern Ireland due to the provisions of the Northern Ireland agreement between the EU and the UK following BREXIT.

The legislation adopted at EU level aims to safeguard the safety and health of patients and medical personnel alike, the economic and legal interests of healthcare providers and consumers, as well as offering redress and general product safety systems. The laws protect patients and medical personnel from risks that they would ordinarily not have the power to tackle; empower individuals to make clear product choices; ensure a clear and consistent approach to product claims and information; and bring about measures that directly safeguard people.

The changes to the regulatory regime in the EU was brought about in response to the PIP Breast Implant scandal, where subsequent investigations found not only fault with the manufacturer, but also significant short fallings in product surveillance and notified body monitoring. 

As a result, the EU 2017/745 Medical Device regulation is much larger, with 100 more articles, much more prescriptive, and brings in new rules aimed at safeguarding patient safety.

Some of the key changes are listed below: 

• Unique Device Indicator (UDI) to be phased in
• Increased Post Market Vigilance 
• Authorised Representatives are now jointly responsible for the product with Manufacturer
• Unannounced Audits & Regulatory screening
• Requirements for a manufacturer to have a Quality Management System
• Person responsible for Regulatory compliance

UK Medical Device Regulation 2002, as amended

Following the UK’s withdrawal from the EU, the EU regulation EU 2017/745 was not implemented, due to the delay in implementation following the Coronavirus Pandemic. The Medical Device Regulation 2002 is based on the now withdrawn EU Medical Device Directive, 93/42/EEC. 

To encourage a higher level of patient safety, additional requirements were brought in to this regulation however, such as strengthened requirements relating to post-market surveillance of products and Unique Device Indicator (UDI). 

UK CA Marking

Having withdrawn from the EU, the UK has defined the regime for approval of medical devices. The UK requires that a UK CA mark is applied following conformance with regulatory requirements. This will be phased in for all UK products, depending on product type.

We are happy to help! 

For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.

PPE Regulation (EU 2016/425)

Examination Gloves must commonly satisfy two regulations within the EU and UK. Products will comply with the PPE Regulations (EU 2016/425) and the Medical Device Regulations (2017/745), and Medical Device Regulation 2002. This regulatory compliance ensures the Gloves comply with tough regulatory requirements, giving the user reassurance of the upmost safety in use.

Personal Protective Equipment (PPE) Regulation (EU) 2016/425

The Personal Protective Equipment (PPE) Regulation (EU) 2016/425, which has been adopted directly into UK law, 2016/425, which legislates the making available of PPE to the market. The purpose of the regulation is to ensure the safety of PPE users by the provision of validated, safe, reliable and quality products, with transparency on testing and product capabilities.

Product Risk Categories

Aurelia range of Nitrile and Latex Examination Gloves are Category III PPE, whereas the Aurelia Vinyl and TPE gloves are Category I PPE. 

Product Conformity Routes

Depending on the Risk Category of the product, there are defined routes to product conformity. Category I products require the company to produce a Declaration of Conformity and maintain Technical Documentation. Category III products require an EC Type Examination Certificate (Module B), either a Quality Control monitoring of products (Module C2), or a Production Quality System Audit (Module D) from a Notified body, and technical Documentation to be maintained for the product. A Declaration of Conformity can then be created. 

CE and UK CA marking

CE marked Category III products require for the Module D notified body number to be labelled on pack. UKCA marked require the same with approved body number labelled.

We are happy to help! 

For further help, or information contact your local Supermax Sales Manager, or e-mail This email address is being protected from spambots. You need JavaScript enabled to view it.. For Quality, Regulatory and technical issues contact This email address is being protected from spambots. You need JavaScript enabled to view it.

Dear Customer,

The whole country and indeed, the entire world is in unprecedented times as we fight both the COVID-19 virus itself and the huge impact it is and will cause on all of our lives.

On Friday 20^th March we were approached by NHS Supply Chain, on behalf of the Government’s Department of Health & Social Care requesting all of our stock currently being held in our UK warehouses of Nitrile, Latex & Vinyl examination gloves. After much discussion our entire company agreed it was without question the right and proper thing to do – our National Health Service is about to be tested to its absolute limits and far beyond, and anything we as a company can do to help we all feel that we must do. So we agreed to the request.

I fully understand the impact that this has on all of our customer base and I give all our customers a guarantee that we will do whatever we can to build all our stock levels back up and provide stock to all of you just as soon as we can, but I am hopeful that you will agree that in the current unprecedented circumstances we must protect those that will be doing all that they can to protect us.

The home of our factories, Malaysia, has introduced a Restrictive Movement Order whereby all movement of people and materials are under restriction, thus putting Malaysia into a total lockdown situation. This countrywide lockdown is for a minimum of 4 weeks, however we anticipate this may be extended further. The Malaysian Government has ordered all glove factories including our own that they must run at a maximum of 50% capacity, this basically means that the entire glove industry will be producing 50% less than normal until further notice, whilst at the same time seeing an unprecedented level of requirement from around the world. On top of this the restriction of movement also impacts the manufacturers and key suppliers of various materials utilised in our manufacturing supply chain which hampers all operations even further.

All the above said our factories are working as hard as they can to provide us with as much of the available capacity and this will enable us, we hope, to continue to help the NHS as much as we can and provide all other customers with as much as we can in terms of stock in the coming weeks and months ahead.

As a business since Wednesday 11^th March all our staff were instructed to cease all non-essential travel and all meetings held both on our customer premises and in our own buildings were postponed or cancelled.

We have commenced different shift patterns to enable us to limit the number of employees we have on site and to allow those that are here as much social distancing as is possible whilst continuing to function and operate as a business and from now until Easter our entire business operation and focus will be on providing the NHS with the service they require. Please also be aware that this may continue beyond Easter if dictated to by the NHS and the government.

If you have any questions in relation to the above please do not hesitate to contact your Area Sales Manager.

I sincerely apologise to you all for the major disruption these decisions and measures will cause you and your business, however I hope you can all understand why we felt this was most definitely the right thing to do. The medical staff who are leaving their families and putting themselves at risk every hour of every day need our backing and support and this is the best way we feel we can do this in these quite unprecedented time for the planet.

We will make things right with ALL of our customers in time and that is my promise to you.

Finally, can I ask you all to follow the government advice on isolating and social distancing, look out for and support the more vulnerable and elderly members of our society through these crazy times, and, as importantly, please make sure you all stay safe, stay strong and stay healthy.

Kindest Regards

Iain Crawford

Group Managing Director

Supermax Healthcare Limited