UK MDR is the primary standard that mandates requirements for anyone selling medical products in the UK, as it is a vast market that often goes unexplored. After the UK left European Union, there has been some confusion regarding the regulations for medical devices in the UK, mostly whether one’s device is eligible to be sold in the UK with the exact specifications they are sold in the EU. As a result, some companies have decided to skip marketing in the UK altogether and are only selling in the rest of the EU countries. Let’s look closely at the UK regulations to help you understand how.
However, as anyone would agree, the UK market is enormous. There is good news for those who hold out and still want to market their products in both UK and EU. A close look at the current UK MDR regulations shows that very little to no alteration is necessary for most products.
The UK MDR Regulatory framework
The MHRA (Medicines and Healthcare products Regulatory Agency) is a government department in the United Kingdom. It is responsible for licensing all medical devices and medicines in the UK, including those imported from other European Union countries. To place your medical devices in the UK market, you must conform to the UK MHRA.
The MHRA has several vital documents that specify by whom and how a medical device can be marketed in the UK.
A summary of the key requirements of UK MDR
- Any manufacturer wishing to market in the UK needs to follow the route set by the UK government.
- Similar to the EU, the UK also requires each medical device to be marked with UKCA marking that shows conformity.
- The MHRA applies to all devices, including in vitro diagnostic medical devices (IVDs), procedural devices, and custom-made devices. However, unlike MDR, the UK regulation does not have separate regulations for regular medical devices and IVDs.
- A specific UK Responsible Person is required for manufacturers outside the UK. They must bear the responsibility of the products placed in the UK market. This person will also be responsible for carrying out the official functions.
Generally, a manufacturer’s job will include: identifying which products are regulated and what regulations apply to them; providing required information about the product; complying with safety standards set by the MHRA; and submitting post-market surveillance reports as necessary. In short, the entire process is very similar to the EU.
As for the individual device requirements in terms of CER and literature review, the UK MDR regulatory framework is pretty similar to the MDD.
Manufacturing or supplying medical devices in the Great Britain market
As we mentioned earlier, all manufacturer and their devices must be registered in the MHRA. In addition, of course, there are also conformity assessment requirements for the products.
Some of the notifiable steps and key points regarding the MHRA and UK regulations are as follows.
Devices that needed to conform to UK MDR
England, Wales, and Scotland
The countries of Great Britain: England, Wales, and Scotland follow the UK MDR 2002 law. So, the devices need to conform to this document. According to the official site, the devices that will need to be registered are:
- “Class I, IIa, IIb, or III devices you have manufactured
- Class I, IIa, IIb, or III devices you have refurbished or re-labeled with your name
- any system or procedure pack containing at least one medical device
- custom-made devices
- IVDs you have manufactured
- IVDs undergo performance evaluation.”
The UK will only accept products from a UK-based manufacturer. If one is not UK based, they will need to appoint a UK citizen who holds specific responsibilities that include ensuring the declaration of conformity and technical documentation are available, providing the MHRA with necessary information and documentation for demonstration of the conformity of a device, and many more.
For each new registration or any changes to the existing one, a fee of £100 has to be paid.
The Northern Ireland-based manufacturers can freely place their products in the UK market as they have already been through the MHRA registration.
According to the UK government, non-sterile and non-measuring devices that fall into the Class I category and IVDs can get their UKCA marking without any notified body. Other devices that require conformity assessment will need UK approved body. They are similar to notified bodies from the EU. The EU will also no longer recognize notified bodies from the UK. So, if your device, one sold in the EU, has been certified by a notified body from the UK, you may need to go through the conformity assessment again. The UK-notified bodies are now UK-approved bodies.
What are the regulations that UK MDR is based on?
- Directive 90/385/EEC (EU AIMDD)
- Directive 93/42/EEC (EU MDD)
- Directive 98/79/EC (EU IVDD)
As the UK follows the directives mentioned above, the requirements for UK-appointed UKCA markings are also based on the relevant annexes of these directives.
It may surprise the manufacturers of the EU market, which have moved on to the more refined MDR. Note that neither the MDR nor the IVDR took effect before or during the transition period. This means the UK cannot enforce the MDR or IVDR. Hence, the UK MDR is being undertaken.
MDR and IVDR certified devices
The process will be much easier for those who already have their product in the EU market and are looking to place their product in the UK. This is because the UK government gives several benefits for EU-certified medical devices. For example:
- Until 30 June 2023, the CE marking is accepted in the UK. As long as your device is certified according to the MDR, you can market it for its intended purpose and use it in the UK market before 2023, 30 July. Hence, if you are in the middle of your CER process, there is no need to change it this year! Go ahead and market your device in the UK!
- The UK will also accept devices that have been CE marked by the EU MDD or EU AIMDD (before 26 May 2021) or EU IVDD (before 26 May 2022).
These benefits will only last until 30 June 2023, unfortunately. Nevertheless, it still gives one plenty of time to explore the market and analyze the benefits of getting an MHRA certificate for permanently setting up a shop in the UK.