Significance of Article 117 for Drug-Device Combination

What takes place when a medicine has the potential to be both a pill and a device? Think of an insulin pen or an asthma inhaler. These are device-drug combination products and are more common in contemporary healthcare. So, what challenges are presented to ensure their safety and efficacy?

In context, this brings us to Article 117 of the EU Medical Device Regulation (MDR). It aids significantly in the scrutiny of these multifactorial products. For all your manufacturers, healthcare practitioners, or anyone interested in the convergence of medicine and technology, Article 117 will certainly matter.

Mixing Up a Drug and a Device

Products that combine a medicinal ingredient with a device are known as drug-device combos. As the name indicates, drug-device combinations mean both elements work in harmony to provide treatment. Sometimes, the medicine is supplied to the body through the device, and other times, the drug is held in the device.

These combinations present numerous benefits. They improve patient compliance by enabling more precise medicine delivery and reducing negative effects. For instance, a cardiac stent that emits a drug into the body gives the medication right where it is needed, helping lower the chances of blood clots.

Still, these products pose some regulatory issues. The regulations for medical devices are centred on the device only, while pharmaceutical law focuses on the medicinal drug. When both are put together, it becomes ambiguous as to what rules should be followed and how the product should undergo testing and certification.

What is MDR Article 117?

In the framework of European regulation, drug-device combination goods are covered under MDR Article 117. This article was made to address the ambiguity of how these products need to be regulated, certified and approved.

This creates a comprehensive set of laws for composite products containing both a medical device and an active medical substance. It states that when a device product that has a drug should be classified, it overrides a pharmaceutical device product that has a device.

Article 117 also describes how different bodies of regulation should consult one another. When a product contains both device and drug components, responsible stakeholders must collaborate to conduct an appropriate appraisal. This collaboration works to fill holes in evaluating safety, allowing evaluation and federation of regulatory decisions.

Key Requirements of Article 117

Combination drugs have important requirements, which are stated in Article 117. First, the article says that the manufacturer should determine what regulatory path their product should take, which is based on the primary form of action of the product.

If the device component offers the main therapeutic benefit, the product is considered to be governed by medical device regulations. Nevertheless, the drug part must still comply with the safety and quality standards of pharmaceuticals. The manufacturer is obligated to prove that the components interact safely and effectively.

The article also requires that there is consultation with pharmaceutical authorities while the Medical Device Certification is being done for the other devices. This ensures that pharmaceutical experts intervene at the stage where the pharmaceutical dimensions of the combination product are being considered.

They need to submit detailed descriptions of the device and drug components, which include the interaction, their combined safety profile, as well as other evidence necessary for effectiveness in combination with each other.

The Consultation Process

The mandatory consultation process under Article 117 is the most distinctive feature of the whole document. Each notified body must, as a matter of law, consult with the relevant pharmaceutical authority while reviewing a drug-device combination for Medical Device Certification.

This consultation guarantees that the drug safety professionals look at all the pharmaceutical issues related to the product. The drug component's efficacy, safety, and quality are assessed by the pharmaceutical authority. They also evaluate the interfaces between the device and the drug components.

The consultation processes may extend the certification timeline. Regardless, it is important from a safety perspective. It makes sure that the combination product follows all necessary relevant expert scrutiny.

The pharmaceutical authority gives a scientific opinion on the drug component and how it is compatible with the device. This opinion is used in the general evaluation of medical device certification in the MDR Article 117 frameworks.

Advantages for Customers Concerning Safety

The different kinds of regulatory specialization add to the consultation. Experts on devices concern themselves with the mechanics and electricals of the device, while pharmaceutical experts focus on interactions, ways drugs enter the body, and the killing properties (toxicity) of the drugs. Having this kind of help makes assessing safety simpler.

The protection of Article 117 ensures that combination products are treated the same way as separate ones in terms of standards. This helps prohibit producers from relaxing strict rules by combining the products in an unsafe manner.