News in Brief

Safety-engineered syringes

In 2015, the Who introduced a new policy on injection safety and asked that the worldwide community change to safety-engineered syringes by 2020 if possible.

Posted on 17. Mai 2019

Device registration and legacy devices

The Medical Devices Coordination Group (MDCG) recently published two guidance documents to further clarify registration timelines under the MDR and registration expectations for legacy devices.

Posted on 15. Mai 2019

Spinal Implants: acquiring a practicable regulatory route through complicated EU MDR wording

EU notified body groups are working towards a standardised interpretation of the EU MDR relating to the risk classification of spinal implants.

Posted on 14. Mai 2019

The safety of Phthalates in question again

Phthalates are a group of materials extensively used in medical devices but are very controversial because of the reproductive toxicity and the possible endocrine disrupting activity some of them have. Now the Scientific Committee on Health, Environmental and Emerging Risks … Continue reading

Posted on 13. Mai 2019

Why it could be better not to make use of EU MDR’s four-year extension

The new EU Medical Device Regulation provides firms with a possibility to market CE-marked devices for further four years under current directives.

Posted on 26. April 2019

EU held responsible for regulatory shortfalls in Implant files

The International Consortium of Investigative Journalists’ published its impact files last November accusing the medtech industry of putting profits before patient safety, of damaging the EU’s best efforts towards better regulation and dealing with patients like guinea pigs.

Posted on 24. April 2019

Eudamed on course for March 2020 restricted go-live

Although Eudamed is mostly on target, there could be some delay in the readiness of certain essential parts of the EU’s updated medical device database. Stakeholders are striving for a May 26, 2020 deadline for the full application of the … Continue reading

Posted on 22. April 2019

ISO 14155 Third edition update in 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019.

Posted on 21. April 2019

New Vigilance Reporting Templates Published

The European Commission has recently published a new reporting template for serious incidents under the MDR/ IVDR and incidents under the MDD/ IVDD/ AIMDD. You may either download the template on the corresponding website or get in touch with mdi … Continue reading

Posted on 17. April 2019

Brexit Update

Brexit day has been postponed until October 31, 2019. A non-regulated Brexit thus has been averted for now. Should you have any additional questions, please get in touch.

Posted on 17. April 2019
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