When you want the best regulatory strategy and solutions for your medical devices (MD), in vitro diagnostic (IVD) medical devices or drug-device combination products, ask DRA to plan it for you. Our highly qualified experts have the skills, knowledge and attention to detail needed to ensure a successful registration process and fast market access. Our experts will navigate the EU’s complex health technology regulations and requirements, and identify the best way to get your devices CE marked and placed on the EU and Nordic markets efficiently and with high expertise.
Our regulatory and market access services include:
- Classification and planning the best strategy for CE marking
- Preparing and maintaining technical documents and product information
- Notified body and Competent Authority applications and engagement
- Registrations for economic operators, EUDAMED and national portals
- PRRC (Person Responsible for Regulatory Compliance)
- Due Diligence and Gap Analysis
- Traceability issues and UDIs
- Establishing QMS
- Quality agreements and supplier evaluations
At DRA, we offer services to support economic operators at every phase of the product life cycle to simplify your route to market. We have the knowledge and understanding of the latest requirements on medical device such as MD Regulation and we can ensure that your company maintains compliance wherever you are in the supply chain.
We’re familiar with the latest regulations and processes, including registration with the European database on medical devices (EUDAMED), registration with National Competent Authorities (NCA), engaging with Notified Bodies and communicating with Competent Authorities. We know all the different Notified Bodies throughout Europe and the Nordics and we know the ins and outs of the application procedure. Let us find the right body for your MD and IVD products.
Our services include full support for your supply and supplier evaluations, due diligence and gap analysis, including reviewing existing technical documentation, reviewing your QMS, and translating, writing, compiling and updating documents and quality agreements.
To ensure patient safety, MD and IVD devices must be traceable throughout the entire supply chain, all the way from the manufacturer to the end user/patient. Let us develop supply chain and traceability strategies for you and assist with Field Corrective Actions.
Biological medicines: how does their manufacturing process differ from traditional medicines?
The differences in the manufacturing process and the nature of the active substance itself mean that biologicals differ from traditional medicines in many ways.
EU Council to postpone the MDR deadlines
The commission’s plan would not automatically apply an extended transitional period for all the medical devices, but the extension would be allowed on the condition that it is critical for the safety of the patients.