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Henny Koch 

Qimp Management Systems Ltd

Henny is member of the RQA Medical Device Committee and professionally a Quality & Regulatory consultant for the Life Science Industry. With 45 years in the pharmaceutical industry covering several positions; 18 years in R&D, 7 years in manufacturing, 20 years in Quality & Compliance covering GCP, GMP and GDP area including 8 years as independent consultant. 

Focus is on Quality Management and quality metrics fostering Business Continuity and the guidance of regulatory processes for the combination of medicinal products and medical devices.

Qimp Management Systems Ltd. focusses on engaged improvements and business solutions with reference towards patient safety and well-being. As advisor, he strives to improve ethical awareness, commitment and collaborative platforms.


Abstract

EMA Quality Requirements for Drug-Device Combinations aligned with Medical Device Regulations 2017/745

Legally binding EU Regulations 2017/745 on medical devices covering the product lifecycle result in increasing demands for development and control of medical devices, will fully apply on 26th May, 2020. Pharmaceutical companies are increasingly aware that in the Marketing Application Authorisation of their medicinal products, for administration and/or support often a (medical) device is used.

Article 117 of the MDR 2017/745 amends Directive 2001/83/EC concerning medicinal products for human use: If a product is governed by Regulation 2017/745, the Marketing Authorisation Dossier shall include, where available, the results of assessing conformity of the device part with relevant safety and performance requirements set out in Annex I to that Regulation contained in the manufacturer's EU declaration of conformity or the relevant certificate issued by a Notified Body allowing the manufacturer to affix a CE marking to the medical device.

Increasing transparency and consistency of information in regulatory submissions, the EMA released a draft guideline on the quality requirements of human medicines that include a medical device.

Covering all medical device classes, this impacts early development with increased demand on clinical evaluation to include relevant data (reference to literature is not enough). With continual attention towards mitigation of risk, this covers clinical evaluation, clinical investigations, vigilance and post market clinical follow up. 

Although this will be challenging for pharmaceutical industry, it also reveals opportunities for the Marketing Authorisation Holder.

Although scheduled within the stream for medical devices, the information is primary of importance for pharmaceutical, biotech and biosimilar companies.

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