lowendahl.eu - News and information

lowendahl.eu - News and information

Corrigendum MDR/IVDR

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 propsal
Here tou find the IVDR proposal

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Authorised representative

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.



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Status Notified Bodies

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,









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FAQ MDR Transitional provisions

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
d. Vigilance
e. A valid EC certificate
f. Be compliant with MDD

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Brexit-EU guidance

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



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Brexit and Notified bodies

MDR/EU relatedPosted by Peter Feb 26, 2019 18:05:17
We get many questions about what to do if you have an UK Notified body. For the 4 that still are around we typical gives the following advice:

BSi - are good in communication, all customers have been urged to transfeer to BSi Netherlands, the only questions are if the have the capacity to deal with all activities!

For customers of the other 3 life is more troublesome!

LRQA- their dutch entity have not been notified for MDD (or MDR) why the likelhood to be able to transfeer all customers before a possible hard brexit is low even though they would get the notification in march.

UL- plans to start activities in Ireland, but have not been notified and currently status are unclear. With that the likelhood to meet deadline at a hard brexit are low and even meet a possible two month delay of a hard brexit that has been discussd today (26 of February

SGS - they have to NBs in Belgium and Finland but there have not been any information coming out from the UK office that they can transfeer to these. Rathercthe opposite customers have got letter saying they cannot transfeer, probably because of the more narrow scope for the other two locations.

Advice:

Build up stock at distributors, urgently look for an new NB (even though getting late) or hope for the best are common advices given! And frankly there are not that many options!
There are a process for companies that loose their NB, in Practise this means that you have 12 months to find a NB, but you need to contact the authority where you have your business if in EU, for e.g. US companies the process is unclear since the authority in UK would cease to exist!





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Brexit and EUs Q&A for medical device manufacturers

MDR/EU relatedPosted by Peter Feb 26, 2019 07:54:46
1st of February 2019 the EU comission published

QUESTIONS AND ANSWERS RELATED TO THE UNITED KINGDOM'S WITHDRAWAL FROM THE EUROPEAN UNION WITH REGARD TO

INDUSTRIAL PRODUCTS. In practise this means a lot of problems for many many manufacturers, but in the end probably could effect patients.

UK based Notified Bodies will loose their notifications that day meaning that even though you are not a UK company but have Loyds UK, BSi UK, UL UK or SGS UK you cannot CE mark after that date. These 4 stands for about 35% of all product in EU!

Read more here:

https://ec.europa.eu/info/sites/info/files/qa_brexit_industrial_products_en.pdf



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