An amendment to the Regulation (EU) 2017/745 (also known as MDR) was adopted on 24 April 2020 by European Commission, which postponed the application of most of its provisions by one year, until 26 May 2021. Originally, the manufacturers of currently approved medical devices needed to meet the requirements of the regulation by May 26 2020.
A lot of questions on the compliance procedures have emerged during the transition period. In order to support manufacturers on this road to compliance, seQure has answered some of the common questions we have heard from clients and industry colleagues.
Short course on the Medical Device Regulation (EU) 2017/745
Jon is the founder and VP of QA/RA at Greenlight Guru (MedTech Lifecycle Excellence platform exclusively for medical technology companies) & a medical device guru with nearly 20 years industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. Thats why he created…
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EMERGO SUMMARY OF KEY POINTS:
Now that the European Parliament has voted to approve the Medical Device Regulations (MDR), many medical device companies active in Europe have begun mapping out how the new Regulations will impact their business. Based on feedback from clients as well as our own analysis of the MDR, Emergo has identified ten common industry questions and concerns regarding the EU Parliament-approved new regulation.
Why is Post Market Surveillance an important part of the Medical Device Regulation?
Systematic monitoring of the post market surveillance system is necessary in order to ensure detection of risk and the implementation of the action to control it, ensuring that the safety profile of the medical device product is always updated.
The future implementation of the EU MDR has increased the barriers to entry in the European Union (EU), and apparently more Medtech companies are looking to other alternative markets (e.g., US, Asia, Latin America) to first initiate their commercial activities. These are some of the questions that come to mind around the topic (you don’t have to share confidential information):
FAQ
What are the key elements in the MDR?
MDR services are delivered in a variety of ways, though the industry seems to agree on the following elements as the most basic deliverables of an MDR service: proactive response. cyberthreat hunting. 24/7 operations.
What are the new EU MDR requirements?
What is the difference between EU MDR and EU?
