Come and listen to us but also many other comeptent speakers at the 2021 PLM forum. For more details and how to secure your access, visit the event page!
Learn more about the challenges posed by Medical Device and In Vitro Medical Device Regulations. Discover how to manage this additional regulatory complexity by improving product documentation. And at the same time make this to be your additional competetive edge
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
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
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.
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
Keeping up with new regulations or guidance can be troublesome or at least take valuable time from your day to day business. New documents releated to MDR are gathered at this page. Other sources are of coarse linkedin, each authorities web pages, but uou never know for sure if something has been posted or not
The first suggested changes to IVDR/MDR are now out for comments. I could not find any bigger changes, but important to review if it effects you! Plan is to get this through Brussels before the EU elections. The suggestion are 125 pages! But dont be scared, it contains all languages! For all Swedes the last 5 pages are for us!
Here you find the MDR propsal
Here tou find the IVDR proposal
To be an EU Authorised representative in the new MDR add many new requirements to be meet. In future posts I will go through these.
In addition to what the role is in MDD the representation means a large undertaking of responsibility. In most corporations this are inhouse task that typical someone at the Quality or Regulatory department have. Going forward this most likely will land at the designated persons desk! What will this mean from a personal risk perspective? Right now no one really knowes! Hopefully the law firm speaking about this at the Regulatory Summit
will shed some light, at least for the people in Sweden. The personal risk will probably differs between countries due to the national view and traditions. Clearly something to make some reasearch about before signing up for the role.
