MDR/EU relatedPosted by Peter 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!
MDR/EU relatedPosted by Peter 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/EU relatedPosted by Peter 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/EU relatedPosted by Peter 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
MDR/EU relatedPosted by Peter Mar 26, 2019 07:49:58
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
MDR/EU relatedPosted by Peter Mar 18, 2019 21:31:34
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 propsalHere
tou find the IVDR proposal
MDR/EU relatedPosted by Peter Mar 14, 2019 08:02:19
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.
MDR/EU relatedPosted by Peter Mar 11, 2019 18:55:26
Enf of February 42 Notified Bodies had applied for MDR, 25 joint assessments have been done and another 4 is scheduled. These figures looks clearly much better than just a month ago and I know that a few other are in the progress of applying.
However more important, when are they approved that companies can start plan for a life after May 25, 2020. Very few of the Notified Bodies communicates where they are in the process and I understand them. No one want to promise to much!
Also folllow Medtech Europe for their updates here
MDR/EU relatedPosted by Peter Feb 27, 2019 13:57:05
What applies to your products in terms of deadline when your products and Quality systems must meet MDR completely?
CAMD publiced a document with the most common qestions and answers which can be found here
Note that for products that can be sold after May 25, 2020 No significant changes in the design and intended purpose can be made.
And no new products can be released.
Certain areas of MDR must be meet for all products May 25,2020. There are exceptions for each of them why you should read the carefully if you plan to implement this later.
a. Registration of economic operators and of devices
b. Post market surveillance (PMS)
c. Market surveillance
e. A valid EC certificate
f. Be compliant with MDD
MDR/EU relatedPosted by Peter Feb 27, 2019 08:03:59
About a year ago EU issued a guidance document to consider before a possible Brexit. The Q&A posted further down add certain information to this document but are in essence very important to read if you are in a situation of having a UK NB or Business in UK both from sales and supplier perspective! Will be happy to answer any questions you might have here!
EU Brexit Guidance