Devices and IVDs.
Medicinal products and devices are both subject to the rules of the single market and have a direct impact on people’s health. However, they have different definitions, legal frameworks and regulatory procedures.
According to Directive 2001/83/EC, a medicinal product is a substance or combination of substances that is used for the treatment or prevention of diseases in human beings. A medicinal product must undergo a conformity assessment to demonstrate its quality, safety and efficacy before it can be authorised for placement on the market. The conformity assessment usually involves clinical trials, which are systematic investigations of medicines in humans.
There are different types of procedures for obtaining a marketing authorisation for a medicinal product in the EU, depending on the scope and characteristics of the product. The main ones are:
- The centralised procedure, which is mandatory for certain categories of medicines (such as biotechnology products, orphan medicines, advanced therapies and medicines for rare diseases) and optional for others. This procedure allows the applicant to obtain a single marketing authorisation valid throughout the EU, as well as in Iceland, Liechtenstein and Norway. The application is submitted to and evaluated by the European Medicines Agency (EMA), which issues a scientific opinion that is then adopted by the European Commission as a decision.
- The decentralised procedure, which is used when the applicant seeks simultaneous authorisation in more than one EU Member State for a product that has not yet been authorised in any Member State. The applicant chooses one Member State as the reference Member State, which prepares a draft assessment report that is then shared with the other concerned Member States. If they agree, each Member State grants a national marketing authorisation.
- The mutual recognition procedure, which is used when the applicant seeks authorisation in other Member States for a product that has already been authorised in one Member State. The Member State that granted the initial authorisation acts as the reference Member State and sends its assessment report to the other concerned Member States. If they agree, they recognise the authorisation granted by the reference Member State.
Once medicines are placed on the market, they are monitored throughout their entire lifespan by the EMA under the pharmacovigilance system, which records any adverse drug effects in daily clinical practice.
According to Regulation (EU) 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for one or more specific medical purposes. These purposes include diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation or compensation of an injury or disability; investigation, replacement or modification of anatomy or physiological process; or control of conception.
A medical device must undergo a conformity assessment to demonstrate that it meets legal requirements to ensure it is safe and performs as intended. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device. EU Member States designate accredited notified bodies to conduct conformity assessments.
Medical devices are classified into four risk classes: I (lowest risk), IIa, IIb and III (highest risk). For certain high-risk devices (such as implantable devices), notified bodies shall request the opinion of specific expert panels before issuing
the certificate of conformity. These expert panels benefit from EMA’s technical and scientific support.
In some cases, the notified body must seek a scientific opinion from EMA before issuing a CE certificate. These cases include:
- Medical devices with an ancillary medicinal substance (such as drug-eluting stents or wound dressings with antibiotics). EMA assesses the quality, safety and usefulness of the ancillary medicinal substance in relation to the device.
- Companion diagnostics (‘in vitro diagnostics’) that are essential for the safe and effective use of a medicinal product that falls within the scope of the centralised procedure (such as tests for biomarkers that determine eligibility for a targeted therapy). EMA assesses the suitability of the companion diagnostic to the medicinal product.
- Medical devices made of substances that are systemically absorbed by the human body (such as collagen implants or hyaluronic acid injections). EMA assesses whether these substances comply with the requirements laid down in Annex I to Directive 2001/83/EC.
In conclusion, medicinal products and medical devices have different definitions, legal frameworks and regulatory procedures in relation to European regulation. However, there are also some areas of overlap and interaction between them, especially for combination products that contain both a medicinal substance and a device component. In these cases, EMA plays a key role in providing scientific opinions and supporting expert panels to ensure the safety and performance of these products.
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