[cryout-multi] [cryout-column width=”2/3″]Establishing a European presence is a big undertaking and requires expert advice and careful planning. Our regulatory team will guide you through the regulatory minefield and ensure a clear path to market.
So what does this involve? Our work includes:
- Advice on exporting to Europe including assistance with logistics, product release, regulation and European law
- Preparation of responses to competent authorities, comment letters, and assessment reports
- Representation to competent authorities and meeting planning
- Regulatory submission critique including recommendations to help
improve review of applications by competent authorities
- Assistance in responding to compliance issues
- Accurate labelling and language translations
- Due diligence on product regulatory packages
- Dossier submission to competent authorities
Regulatory and technical assistance for class I, II, and III medical devices
Class I devices (including sterile, non-sterile and measuring function)
We can provide general pre-CE-marking assistance by reviewing your product, determining its device classification and route to conformance. We can assist with technical file preparation and maintenance. We can provide advice on labels, checking compliance and claims and instructions, and arrange translations. We’ll help ensure QA compliance including operating procedure advice and writing, as needed.
Class II and III devices
We can advise and assist you with regulatory matters and liaise with the notified body. We’ll prepare (and submit) documentation to support clinical investigations or studies.
Non-EU device manufacturers
For device manufacturers outside the European Union, we’ll act as your authorised representative and maintain a watching brief on all matters of concern including regulatory updates.
Medical Device Support will liaise with competent authorities in respect of vigilance matters. We advise, assist, and submit adverse incident reports as required to the relevant competent authorities on behalf of our clients.
CE mark services
In some EU member states the authorised representative will have responsibilities directly under national law. For instance, he might have to ensure appropriate conformity assessment procedure has been carried out, that the device is properly CE marked and information provided in a specified national language.
Our services do not involve generating CE mark.
Getting your IVD medical device to market
In vitro diagnostics (IVD) is an important and growing segment in the global healthcare industry. Growth is fuelled by technological advancements, better diagnostic tools, improved treatment monitoring, and increased availability of over-the-counter tests.
Our experienced team can help you in getting your IVD device to European markets efficiently. Our experts have both industry and regulatory experience, resulting in a comprehensive understanding of your needs and challenges.