CERT overview – What qualifies as a medical device or Medicinal Product in the EU or UK
CERT overview – What qualifies as a medical device or Medicinal Product in the EU or UK
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Where do the Guidelines come from?
Effective consumer protection policy is vital for ensuring the proper functioning of the single market; it secures consumers’ rights when dealing with businesses and offers additional safeguards for vulnerable groups. The legal foundation is set out in Articles 4(2)(f), 12, 114 and 169 of the Treaty on the Functioning of the European Union (TFEU), alongside Article 38 of the Charter of Fundamental Rights of the European Union.
Parliament regularly refines and strengthens EU consumer protection legislation. The focus has shifted from simply setting technical standards to promoting a broader ‘citizens’ Europe’ objective. Since 13 June 2014, Member States have enacted national laws under the Consumer Rights Directive, following substantial endorsement by Parliament.
On 12 December 2017, the adoption of Regulation (EU) 2017/2394 further enhanced cooperation among national authorities to enforce consumer protection laws across the EU.
In the UK the Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. They operate in a statutory framework set by HM Government, working within government and the wider health system to direct overall policy in our regulatory field.
The Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) Codes contain numerous provisions reflecting key aspects of EU law, as well as UK legislation adopted to implement EU requirements.
This statement outlines the principal legislative measures designed to ensure the UK’s statute book remains effective post-EU exit, and explains their impact on the CAP and BCAP Codes. In essence, CAP and BCAP advise advertisers that, following the UK’s departure from the EU on 31 January 2020, all regulatory rules in force immediately prior to exit will continue to apply throughout and beyond the transition period of the Withdrawal Agreement—unless expressly amended by CAP or BCAP.
Advertisers must comply with all applicable CAP and BCAP Code requirements unless formally notified of exceptions. CAP and BCAP will review and implement any necessary updates as further government guidance becomes available, acting promptly to ensure the Codes remain fully up to date.
“A medical device is any product used for medical purposes, including diagnosis, prevention, treatment, investigation or changes to anatomy, as well as contraception devices and sterilising medical equipment.”
Regulation (EU) 2017/745 (Medical Devices Regulation) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation) establish the framework for placing medical and in vitro diagnostic (IVD) devices onto the market, as well as conducting related clinical investigations.
These regulations entered into force in May 2021 and May 2022, respectively. Medical devices are categorised by risk, with each category subject to its own specific rules. The regulations introduce stricter requirements for conformity assessment and post-market surveillance, mandate the generation of clinical safety data, implement a unique device identification (UDI) system to enhance traceability, and provide for the creation of a European medical device database.
Regulation (EU) 2023/607 amends the above legislation, adjusting transitional provisions for certain medical and IVD devices. This update introduces a staggered extension of the transition period for affected devices, subject to defined conditions. It also removes the ‘sell-off’ deadlines from both the Medical Devices and IVD Regulations—meaning that devices placed on the market before or during the transition periods may remain in the supply chain, without being subject to mandatory withdrawal dates.
The Medical Devices Regulations 2002 (“the Regulations”), as amended, transpose various EC Directives into UK law.
The Regulations define a medical device as: “an instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any software necessary for its proper application, which is intended by the manufacturer to be used for human beings for the purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; or control or conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means”.
The definition includes devices that are: “intended to administer a medicinal product or which incorporate as an integral part a substance of which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.”
Medical devices are of three types: general, active implantable and in-vitro diagnostic (the last two are specifically defined in the Regulations). If a product does not have one or more of the medical purposes referred to (for example, it has a purely cosmetic purpose) it does not fall within the definition of a medical device.
Article 1 of Directive 2001/83/EC as amended defines a “medicinal product” as: “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; [the first/presentational limb]
Any substance or combination of substances which may be used in, or administered to human beings, either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis” [the second/functional limb].”
If the MHRA classifies a product as a medicine, marketers need to obtain the appropriate licence and marketing authorisation before selling or marketing that medicinal product in the UK. Once the appropriate licence has been obtained, marketing communications for that medicine must conform with the licence and the accompanying Summary of Product Characteristics (SPC).
The information provided here is for general informational purposes only and does not constitute legal advice. No consultant-client relationship is established through this communication. For advice specific to your situation, please consult with the most relevant consultant in our team by going to www.reviewmyproject.com.
