Busy times and the need for information is high. Currently Peter Löwendahl is scheduled to talk at:
AI in healthcare Gothenburg February 6
Regulatory summit Stockholm February 20
Rockstart, Netherlands February 2
Affärsutveckling medicintekniska produkter Stockholm 11 mars
Upphandlingskonferensen 2020 Stockholm 25-26 mars
Hoff & Lowendahl have Signed an agreement with Sensely to be authorised representative in EU. Sensely are a manufacturer of AI based software for guiding patients In helathcare settings based on symptoms.
FDA have many guidlines and are outnumbering EU competely!
They have a page that also lists the latest guidelines in case you noticed one in the news flow but not find it when you search. Use the following link
Often I get the question about where to find MDR/IVDR guidance document. Even though e.g Google or Bing search engines should get you there I post the link here to make it easier to find. https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
25-26 mars 2020 är den stora upphandlingskonferensen som Swedish Medtech anordnar tillsammans med några andra organisationer. Peter Löwendahl tillsammans med Läkemedelsverket kommer att ha workshops gällande MDR och bland annat ta upp hur upphandling påverkas av eventuell brist på anmälda organ. Mer information kommer när programmet är slutligen satt.
Finally the guidance came. A few intresting calls and even surprises in the examples. Read it yourself to ensure that you got it right! The guidance can be found at https://ec.europa.eu/docsroom/documents/37581?locale=en
February 20, 2020 the next regulatory summit will be in Stockholm. Stay tuned for program, or suggest direct here on what you like to hear mor about!
Medtech Europe have created a guidance document that discuss use of certain symbols like the Medical device symbol – MD-, devices that includes Different types of substances and translations etc. the documents can be found here. These guidance are useful since you wiull know that many comnpanies will use it and hence the power behind this will be strong vs that you find symbols yourself. They have of coarse not just created them, but refers to different ISO standards.
General speakiong, using already existing standards are always better than create something yourself!
What does significant change mean in MDR. It is not described, but COCOR and Medtech Europe have created a position paper which you can find here
All manufacturers will soon be or are already effected by the MDR or IVDR. It is probably worst for the ones that have products reclassified from class I to IIa (see previously posts) but majority of companies are class I companies. These are also effected quire hard depending on how the run their operations today.
The big news for class I manufacturers are that they must have a almost complete quality management system. no need for certification, but when the authorities inspect the companies you better meet ISO 13485 to avoid issues.
Already now the authorities have started to send out letters to manufacturers about the changes. One example is the Swedish authority sending out letters to the CEOs of class I registered products. Hopefully they read it carefully. The letter basically goes through article 10.9 in the regulation.
