Representation

Keeping an eye on legal requirements and meeting them on time requires specialist knowledge and a significant time commitment.

We have the expertise to help you plan for changes in advance and react to any incidents quickly.

Topics

HMV Representative

Getting your product listed on German Medical Technical Aids Register (Hilfsmittelverzeichnis – HMV) is just the beginning. Updates, changes to the product and any alterations to requirements demand your undivided attention if you are not to lose your listing.

If you choose us as your HMV Representative, we will make sure you are kept fully informed of developments and tell you everything you need to do in order to retain your device registration.

Quality Management Officer (QMO)

The EU Medical Devices Regulation (MDR) requires you to maintain a quality management system (QMS). You can rely on our support to tackle any temporary difficulties while you complete the process of appointing a suitably qualified Quality Management Officer.

BEO BERLIN can also provide you with the services of fully-trained QMO’s so that you can train a suitable specialist while minimising disruption to your business.

EU Authorised Representative

If you are a manufacturer of medical devices based outside of the European Union you must name a natural person as an Authorised Representative (AR). This role comes with major regulatory responsibilities, and is therefore extremely important in ensuring frictionless imports and operations within the EU.

BEO has been acting as a reliable partner for international firms for many years, and we will be delighted to serve as your EU Representative/AR.

Person Responsible for Regulatory Compliance (PRRC)

According to the EU Medical Devices Regulation (MDR), all manufacturers of medical devices are required to name an individual responsible for compliance with regulatory requirements. This role may only be fulfilled by individuals with the appropriate qualifications as defined by law. It carries a high degree of regulatory responsibility, and is therefore extremely important for your company.

BEO BERLIN has been acting as a reliable partner for medical technology firms for many years, and we will be delighted to serve as your PRRC.

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