News
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Origin of meat shall be provided in writing to consumers in restaurants as of 1st May!
The Finnish Food Authority’s Food guide for Finnish food inspectors and food business operators (Elintarviketieto-opas) was updated in April and it provides information on when and how to indicate the origin of meat and how foodstuffs should be named. For bovine, pork, sheep, goat and poultry meat (also minced meat) used as a meal component […]
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On-line training: Medical devices and clinical investigations
Are you working with medical devices and planning to start clinical investigations at some point? We have some good news for you – Medfiles’ new On-line training, tailored especially for your needs. Our regulatory and clinical teams have compiled a training according to Medical device regulation (MDR) 2017/745 that can help you in decision making […]
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Transition period for the Medical Devices Regulation (MDR 2017/745) is coming to an end in May 2020. Are you prepared for the change?
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on Medical Devices entered into force on 26 May 2017. Accordingly, the transition period of 3 years is coming to an end in the spring next year. The new Medical Device Regulation (MDR) will replace the Directive 90/385/EEC concerning active […]
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Overview of Electronic Applications for Marketing Authorisations in the EU
Electronic processing of marketing authorisation activities has taken leaps forward during the last few years on the European level. Paper submissions are almost in the past and different kinds of electronic portals have replaced them. Introduction of electronic application forms and eCTD needs more technical approach, but on the other hand, practical work has become […]
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We proudly inform that senior regulatory affairs expert Merja Vainio is our new medical device specialist, strengthening Medfiles’ regulatory affairs service offering.
Merja Vainio has worked for 20 years in medical device and in vitro diagnostic industries and has a profound expertise in MD and IVD regulations, risk management and quality management systems. Over the years, she has developed and productised several medical devices and in vitro diagnostic tests from a product idea to post-market surveillance actions, […]