To introduce a medical device into the market of the European Union it needs to comply to the Medical Devices Regulation (MDR; or: (EU) 2017/745) and for this the manufacturer needs to provide a technical documentation for each medical device or product group. This is required according to Annex II and III in addition to a quality management system (see Annex IX MDR). The technical documentation contains all relevant information over the entire product life cycle, from product development to disposal and demonstrates the essential safety and performance requirements according to Annex I of the European legislation, the MDR.
For Medical Devices there are usually original equipment manufacturer (OEM) or private legal manufacturers (PLM). Under the MDR legislation any legal manufacturer must provide the technical documentation of the medical devices it made. However, the formerly known OEM-PLM model depends on their relationship, business model and structure and is not allowed to be continued as such.
If a legal manufacturer established outside the EU has a European authorised representative (EAR) according to Article 11 of the MDR, it must also provide the technical documentation at any time, for example during an audit by the competent market surveillance authorities.
The conformity assessment procedure to be applied depends on the risk class of the medical device according to Annex VIII. The scope of any technical documentation depends largely on the risk assessment of the product, especially regarding potential deviations from the defined functionality. For all medical devices outside risk class I the involvement of a Notified Body is required.
In addition to the implemented quality management system, there will be the technical documentation for its conformity with the MDR examined. Upon request, it must be possible to make extracts or provide the entire technical documentation available to the national market surveillance authorities at any time.
With introducing the MDR the regulatory requirements related to technical documentations have changed significantly compared to the previous directive (MDD) - making it more dynamic in the future. Particularly noteworthy are the post-market surveillance reports (PSUR). Conclusions derived from PSURs need to be analysed and required adjustments to processes, the clinical evaluation or even the product itself must be evaluated. It is important to ensure necessary internal or external responsibilities as well as human and material resources are available.
The structure of any technical documentation needs to be planned at an early stage and kept up to date throughout the whole lifecycle of the medical device/-s it describes. Our experts will help you to prepare a comprehensive technical documentation on your way to a hassle-free approval of your medical device on the European market.
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