DRUG-DEVICE COMBINATION PRODUCTS

That depends on the classification according to Annex VIII MDR of the device part of your product. Regulatory experts, like our team, can provide the necessary support. Consulting with us can help ensure compliance and streamline the process.

The timeline varies, but it typically takes several months. Early engagement with a Notified Body and well-prepared documentation can expedite the process. We can help manage expectations and prepare your submission.

You can select any Notified Body designated for the specific product category, but availability and expertise vary. We can assist in identifying the right Notified Body for your needs.

Yes, technical documentation per Annex II is usually required but not mandatory. We can assist in preparing comprehensive documentation and presenting it in a structured manner.

Yes, depending on the product, additional regulations such as GMP requirements or specific national laws may apply. Our team can guide you through all relevant obligations.

The quality management system should consider and reflect specifics of both worlds, e.g. handling of changes. We can assist in evaluating and adapting your system.

PMS must be conducted according to drug regulations, considering in addition, device specific requirements. It involves monitoring the product's safety and performance. We can support you in setting up an effective PMS plan.

Our regulatory experts can help assess whether a change is considered significant under the applicable regulatory frameworks and guide you through the appropriate steps.

The required data depends on the nature and impact of the change. Generally, safety, efficacy, and quality data must be reviewed. We can help determine the specific requirements for your case.

You will need to provide evidence of safety and performance by e.g. the certificate of the co-packed medical device, along with data on packaging and labelling. We can help you compile the necessary information.

Yes, specific requirements may exist for labelling, packaging, and supplier management. We can guide you through these additional obligations.

Performance testing typically includes functionality, safety, and compatibility with the drug. We can help design a testing plan tailored to your product.

For products that don't fit standard classifications, a detailed regulatory strategy is required. We can help you navigate through the classification challenges and advise on the best course of action.

Depending on the field of law that is primarily relevant, you also need to check the combination product broadly as a medicinal product or as a medical device. We can help you with the decision taking.

The medicinal product dossier should include a discussion of the impact of the device (part) on the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), and overall strategy of the medicinal product. We can assist in preparing comprehensive documentation and presenting it in a structured manner.

The competent authorities will evaluate the device (part) specific aspects relevant to the quality safety and efficacy (and hence overall benefit/risk determination) of the medicinal product. Regulatory experts, like our team, can provide the necessary support with the preparation of the documentation.