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Qmed Consulting Newsletter / October 2015
CER Brochure: A guide on the writing process

Every medical device sold in Europe must have a CER in its technical file. Qmed Consulting can help you update your CER writing process. Download the free .pdf guide:

CER Brochure
Endgame in new EU legislation for medical devices
Aiming to modernize the legislation for medical devices, the EU Commission in 2012 presented proposals aiming amongst other things, to increase the scrutiny of products entering markets, tighten surveillance on existing products and implement a unique device identification system. Now the endgame is near to strike the optimal balance between the safety and the accessibility of new medical products entering the market.

The existing three directives will be replaced by two regulations. One on medical devices and the other on in-vitro diagnostic medical devices. The Commission, the Council and the European Parliament will now enter in the so-called trilogue to work out a final text which is expected to be finalized towards the end of the year or in the beginning of 2016. In other words, representatives of the EU’s three main institutions are now meeting up trying to compromise on the two draft regulations.

There are many interesting perspectives in the drafts. First of all, the change from directives to regulations will prevent the crop of national deviations and additional requirements. Secondly, the stricter rules for new class III devices will require that clinical investigations be performed before high risk products can enter the market. Thirdly, the increased scrutiny procedure will ensure that the assessment of novel technology by a Notified Body is also reviewed by a panel of independent experts. Fourthly, by creating public access to basic information regarding devices undergoing clinical investigation, devices placed on the market, summary information on the safety and performance of devices on the market and the occurrence of serious adverse events will provide more transparency into the system. Lastly, the requirements regarding the insurance that manufacturers must contract to cover any litigation from patients who have been hurt by defective products will ensure that financial compensation will be available, even if the device was not manufactured by a large-sized company.

A lot can still change during the trilogue but the expectations are high. You can read more by following the link below:
Denmark – the land of clinical trials
Did you know that even though Denmark is a small country it has a well known reputation for being a world leader in clinical trials with 13 percent of the Danish population participating in clinical trials or medical research? Denmark hosts more clinical trials per capita than any other country in the world, measured by in October 2013.

Part of this story can be seen with the footprints of the Medicon Valley, which is one of the strongest life science clusters spanning the Copenhagen area as well as the Skåne region of Southern Sweden. Medicon Valley houses more than 200 medtech companies. In 2012, the medtech industry in Greater Copenhagen posted a turnover worth 6.7 billion euro.

Denmark is divided into five regions with one to six related committees meeting on a monthly basis and the response time is considered very fast. Normally, the response time is less than 60 days but you can experience some delays in the Capital Region of Denmark. The committee for Region Zealand and North Denmark Region meets every second month, while the other regions have several committees and meetings per month.

All new trial applications to Danish Health and Medicines Authority must be approved within 60 days and can be done parallel with the submission to the ethics committee. In 2011, 97 percent were replied to within 30 days.
Get up-to-date with Qmed Community
Imagine having one central web address for your entire clinical study team, where everyone has access to the same templates, guidelines and hospital specific documents. That is what Qmed Consulting is launching with Qmed Community for hospitals, study coordinators and investigators. An invitation-only website containing exactly what the hospital team wants electronically filed and shared.

Contact us to arrange for your free demonstration.
The challenges of CER’s – Clinical Evaluation Reports
Are you aware of the changing requirements for documenting your clinical data for your medical devices?

When handling Clinical Evaluation Reports (CER’s) it’s crucial to see the big picture and know about the changing scenarios and requirements for documents and data related to your CER. In the last nine years, Qmed Consulting has completed more than 50 CER’s and have worked hard to get the hands-on knowhow of conducting a well-designed report. In addition, Qmed Consulting is also an expert reviewer for Notified Bodies in more than 70 CER documents. Expertise used as well for training companies and Notified Bodies worldwide on how to complete a CER.

We like to think about Clinical Evaluation Report as a four-legged table with the legs representing your own clinical data, literature search with systematic literature review of clinical investigations, your user manual/Instructions for Use and the risk analysis. All this to make the CER complete so inventors and investors get the proper help in achieving success.

Read more about the world of Clinical Evaluation Reports and learn how to pave the way for new medical device approvals or learn what to do with already existing medical devices.
Are you curious about the possible regulatory changes that are coming in Europe?
We are attending the upcoming TCT meeting in San Francisco from October 10th to October 15th. We would be more than happy to discuss your project or plans and the implication of the coming possible changes. Contact us

Happy Halloween!
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