Medloft Articles

CE mark is required for each medical device sold in EU. Since 26th May 2021 all new devices put on the market shall comply with the applicable requirements of EU...

The increased validation requirements of MDR (EU 2017/745) bring new challenges to the manufacturers of devices utilizing a software and standalone software which are considered as medical device in line...

MDR Clinical Evaluation Requirements including clinical investigation are defined on Chapter VI, Annex XIV and Annex XV respectively. As you know, to CE Mark a medical device under MDR, the...

PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and...

Food and Drug Administration (FDA) is the legal authority to establish rules and regulation for the use of medical devices within the United States. According to Food, Drug, and Cosmetic...

MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to...

Implant card (IC) is one of the new requirements of the MDR – EU 2017/745. The requirements specified in Article 18 will bring new challenges to the daily life of...

ISO 13485:2016 is a quality management standard for medical devices. This standard provides a basis for the quality management system in parallel to the EU MDR and other international regulatory...

The ISO 14971 Risk Management standard defines principles for a risk management process of medical devices. The requirements given in this standard help manufacturers to comply with the main regulations....

The Medical Device Single Audit Program (MDSAP) is led by Australian TGA, Brazilian ANVISA, Health Canada, US FDA and Japanese MHLW to implement a program where Auditing Organizations (AO) can...