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A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 32nd Year of Publication
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Regulation

Navigating Regulatory Landscapes:
Drug-Device Combination Products In The EU And USA?

 

Anil Chaudhari,
Founder
Operon Strategist

What are combination products?

Combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

These products can be composed of two or more components, each of which would typically be classified as a drug, a device, or a biological product individually. These products combine therapeutic agents with medical devices to improve patient outcomes and treatment adherence. The combination of these components into one single product is intended to provide a more effective treatment or diagnostic tool than if each component were used separately. Examples include prefilled drug syringes, Dose Inhalers, drug-eluting stents, insulin pumps and certain diagnostic test kits that include reagents and instruments.

In this article we will discuss what are challenges manufacturers of combination product may face when
seeking regulatory approval for their integral combination product and what are requirements for EU and US markets.

 

Regulatory Framework for Market Access and Commercialization in Europe and US

 

Combination products are regulated by health authorities such as United States (FDA) and European Union (EMA) under specific regulatory frameworks that address the unique challenges and requirements posed by their combined nature.

 

EU regulations for Drug-device combination products

 

Obtaining a Notified Body Opinion (NBOp) will require a significant investment of time and regulatory knowledge and resources. If it is not addressed correctly, the process may directly impact the costs and time to approval. Manufacturers of Drug Device combinations have to opt for Notified Body Opinion (NBOp) to get their regulatory approvals for device components.

 

What is Notified Body Opinion?

 

According to Article 117 of MDR, Integral drug-device combination products DDCs regulated as a medicinal product and NB Opinion (NBOp), is required for those products to obtain marketing authorization for a medicinal product which forms a single integral product with an any medical device. The Marketing Authorization Holder is, if a NBOp is applicable, required to submit the NBOp in conjunction with the Marketing Authorization Application (or variation application) to the Drug Competent Authority.

 

NBOp Technical file of integral Drug-Device Combination (DDC) products need to follow stringent regulatory requirements and technical documentation.

 

 

What should be included in NBOp submission file?

 

Manufacturers needs to identify all the relevant and applicable GSPRs for their combination product with sufficient level of evidence to meet requirements. A significant amount of documentation for device components are required for an NBOp which shall be prepared and maintained by manufacturer.

 

● Documentation shall focus on General description device and components making direct or indirect contact with the human body, Mode of Action, Key Functional Elements.

 

Description of variants and configurations, Accessories, Technical specifications, features, dimensions and performance attributes

 

● Comprehensive Design History File, user instructions, product inserts, and packaging details provide essential guidance for safe application. Harmonized standards and common specifications backed by documents offering robust evidence of conformity.

 

● Manufacturer shall not only focus on the device part, but also on the device part´s interoperability and compatibility with other devices, products or substances, Threshold analysis Report and bench testing data with RLD.

 

● A thorough GSPR checklist identifies and justifies applicable regulatory requirements, while methods to demonstrate conformity include comprehensive summaries of results, supported by raw data and original test report. Technical documentation shall also be supported by detailed clinical evaluation or clinical investigation (If applicable) inconsideration to device type and risk category.

 

What is Role of Notified body?

 

Notified Body sets the assessment based on Article 117 (Regulation (EU) 2017/745 on medical devices (MDR)), and Issues and opinion on the conformity of the device as apart of drug device combination.

 

 

Points to be considered for selecting a Notified Body to issue your NBOp

 

- Do they have experience with providing NBOps?
- Any existing relationships between NB and manufacturer?
- How much charges to provide the NBOp, and is it within your budget?
- What are the NBs’ proposed timelines for complete process?

 

Post market requirements for Drug device combination products.

 

Drug device combination (integral) regulated as a medicinal product, device vigilance requirements for MDR are not applicable but is recommended that manufacturer has the technical knowledge and processes built into their Quality Management System (QMS) for handling, evaluating and investigating, where necessary, all device-related complaints. Manufacturers should review their pharmacovigilance agreements with suppliers to ensure that they take into consideration additional data that may need to be collected and communicated, such as device malfunctions and device-related events.

 

Labelling and Unique Device Identification (UDI)

 

As integral Drug device combinations regulated as medicinal products, the labelling and UDI requirements under MDR are not applicable. When labelling, the integral DDC manufacturer should follow the labelling requirements for a medicinal product.

 

US regulations for Drug-device combination Products

 

Background

 

A provision in the 21st Century Cures Act enacted in December 2016 (PL 114-255) amends section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 USC 353(g)), which addresses combination products (21 USC 353). The amendments aim to enhance clarity, efficiency, predictability, and consistency in premarket regulatory expectations for combination products. This ensures that the FDA’s components and staff coordinate appropriately on premarket review of the combination products and that the agency’s stakeholders are in harmony in conducting these reviews.

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