MEDICINES & HEALTHCARE REGULATIONS
Regulations and the role of the MHRA
At this year’s Theatres and Decontamination Conference, Rebecca Flint, Devices patient safety manager at The Medicines & Healthcare products Regulatory Agency, provided an overview of the medical device directives and regulations, as well as insight into the role of MHRA.
The Medicines & Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. As an executive agency, sponsored by the Department of Health and Social Care, it’s recognised globally as an authority in its field. The agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development. Responsible for ensuring that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy, MHRA’s Rebecca Flint, discussed the Medical Device Directive (MDD) and the new Medical Device Regulation (MDR) during her talk at the Theatres and Decontamination Conference in the Marriott Forest of Arden. The MDR and In vitro Diagnostic Medical
Device Regulations (IVDMDR) replace the current MDD, Active Implantable Medical Device Directive (AIMD) and the In vitro Diagnostic Medical Device Directive (IVDMD). “The MDD, AIMD or IVDMD are the regulations that manufacturers of medical devices have to demonstrate compliance to, if they want to sell their device on the UK market,” Rebecca explained. “The MDR came into force in May 2017 and will apply from May 2020. The MDR has different legal requirements to the MDD and is directly applicable into local law. The
difference between regulations and directives is that regulations are directly applicable, whereas directives can be translated into local law differently by each member state.” Rebecca highlighted that these are not the only differences between the MDR and the MDD: “There are some departments in hospitals where professionals will manufacture their own software, or they’ll make their own medical device. Previously, under the MDD, they wouldn’t have been regulated as medical devices because they would have been made in-house and not considered to have been placed on the market, so people could share them freely with other professionals within the hospital. “With the new MDR there is going to be a requirement for in-house devices to be treated as medical devices, and to comply with the regulations. If you wanted to make your own software, you would then have to have it CE marked as a medical device. There will be certain requirements that you have to meet even if you are only using it in- house. This is called Health Institution Exemption1
and is something MHRA has
written guidance on, which is currently out for consultation. “Another key change is that manufacturers can currently claim equivalence when they are trying to put a new device to market for the purposes of showing clinical evaluation. If the device fulfils the same purpose as another similar device, they may not have to do a
There are many items that people don’t consider to be medical devices… Depending on what the manufacturer wants tocall it, an item could be a medical
device or it may be a medicine. Rebecca Flint, MHRA
16 I
WWW.CLINICALSERVICESJOURNAL.COM Rebecca Flint, MHRA
clinical investigation because it’s essentially the same device. Within the new MDR it will be harder to claim equivalence. Manufacturers will have to prove, by performing clinical investigations, that the device is acceptably safe and meets the essential requirements of the relevant regulation. There are some exceptions given in article 61 of the new MDR.”
Defining a medical device
Rebecca observed that there can be a host of ambiguities when providing a definition for a medical device. “Many people don’t consider a pair of glasses to be a medical device,” she noted. Glasses and contact lenses are medical devices under the MDD but under the new MDR plan contact lenses also have a classification as a medical device as per Annexe 16 rules. This change in the way items are classified will have an impact on how they will be dealt with, and there are different regulations for different types of devices. “There are many items that people don’t consider to be medical devices: padded cushions, wheelchairs and barrier creams for example,” added Rebecca. “Depending on what the manufacturer wants to call it, an item could be a medical device or it may be a medicine. There has been a lot of joint work in some areas of investigation around medicines and devices, because it depends on what the manufacturer says that product is. They may look the same, but if one manufacturer defines it as a medical device and it has a CE mark, while the other one says it’s a medicine with a product licence, then we end up with two completely differently regulated products.”
JUNE 2018
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