MDRC creates technical documentation complying with the European regulatory requirements. We prepare technical files that conform to Regulations EC 2017/745 and EC 2017/746. If your technical files comply with the Directives 93/42/EC and 98/79/EC that expire in 2021 and 2022 correspondingly, we can adjust them and provide a smooth transition to the new European Regulations.

According to the EU regulations medical device companies must implement and maintain a risk management system. MDRC helps manufacturers create 2017/745- and 2017/746-compliant risk management systems.

Clinical evaluation based on current scientific and clinical data is necessary for all devices that do not go through clinical investigations. We can carry out clinical evaluations for your products and compile documentation that complies with the provisions of the European medical device regulations and the clinical evaluation standards MEDDEV 2.7.1. rev. 4.

Classification of medical devices in the European Union is based on the classification rules given in Annex VIII of Regulation EC 2017/745. There are four classes of medical devices in the EU: class I (non-sterile, non-measuring), class I (sterile or measuring), class IIa, class IIb, class III. In the same way, in vitro diagnostic device classification is rule-based (Annex VIII of Regulation EC 2017/746). In vitro devices are divided into classes A, B, C and D. MDRC has a lot of experience in medical device classification for the EU market. We will determine classification of your medical devices in Europe.

Post-market surveillance system is a binding requirement in the EU. It is an integral part of the medical device manufacturer's quality management system. How the system is organized and how it works depends on the risk-based classification of products a company manufactures and sells. MDRC will create the post-market surveillance documentation and help you elaborate and implement the system.

Medical device companies who are interested in the EU market need to actively collaborate with European Notified Bodies. To communicate with your Notified Body effectively you need to deeply understand the EU regulatory framework. We have this understanding and knowledge. We can help you in finding a Notified Body that will fit you and take on a lot of communication on your behalf.

The European regulatory authorities require that medical device manufacturers have the Quality Management System in place. The quality system provisions of the European Union are laid down in article 10 and Annex IX of Regulation EC 2017/745 (in case of in vitro diagnostic devices Regulation EC 2017/746). These provisions are harmonized with ISO 13485. MDRC can create and implement a quality system at your company that fulfills all requirements of the EU authorities.

In the European Union class III, active implantable medical devices and some of class IIb medical devices are subject to clinical investigations. In the case of some high-risk devices clinical investigations might be waived but the waiver must be appropriately justified. MDRC will help you figure out what investigations are required, how to conduct them efficiently, what investigations can be waived etc. We also can organize clinical investigations for you.