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FDA latest guidelines

FDA/USA related Posted on Oct 12, 2019 14:56:52

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



MDR guidance documents

MDR/EU related Posted on Oct 12, 2019 14:47:06

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



Upphandlingskonferansen 2020

Events we speak at Posted on Oct 12, 2019 14:39:34

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.



The new software guidance for MDR/IVDR

MDR/EU related Posted on Oct 12, 2019 07:49:18

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



Regulatory summit 2020

Events we speak at Posted on Oct 05, 2019 20:33:55

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!



Guidance to MDR symbols

MDR/EU related Posted on May 15, 2019 10:13:27

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!



Significant changes MDR

MDR/EU related Posted on May 04, 2019 13:33:16

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

 



MDR and class I manufacturers

MDR/EU related Posted on Apr 10, 2019 14:06:48

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.



MDR Guidance

MDR/EU related Posted on Apr 08, 2019 12:22:49

BSi have issued a document about their best practise when it comes to MDR. Considering that they are the first and only approved MDR notified body this is of coarse very interesting reading. Download your copy here



Electronical invoices

Other Posted on Apr 03, 2019 14:51:34

Did you know that from April 1st you must provide your invoices to public hospitals, communities and states electronically! This is an European requirement.
what is an E-invoice then? It is not a pdf copy of your normal paper invoice! It must meet the requirements in PEPPOL BIS Billing 3. Read more about the standard here

If you do public business better ask your system provider if they meet the requirements, if not you must act now!

The new requirements are valid for new tenders or direct buy and hence not valid for tender that was won before the date.

You can read more about the new law here. This link is in Swedish.



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