lowendahl.eu - News and information

lowendahl.eu - News and information

MDR and class I manufacturers

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.

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MDR Guidance

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

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Electronical invoices

OtherPosted by Peter 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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Find new IVDR/MDR documents

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

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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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Advertising and promotion

Off/on labelPosted by Peter Mar 12, 2019 13:13:41

FTC, FDA and DOJ, is this how it will work with the new MDR?

Most people working with medical devices that are sold in USA knows what FDA do and their role in promotion and labelling activities.
Not all people understand Federal Trade Commissions (FTC) role and escaping or handling FDA does not always mean that you are safe! FTC are perhaps more known for approving deals from a competition perspective, but that’s also why they look at advertisement and promotion.

FTCs basic requirements are quite straight forward and can be found on this link. However even though it should be simple to follow many companies get into trouble.

FDA warning letter
Department of Justice, DOJ typical gets involved when FTC or FDA have found issues, A FDA warningletter itself does not mean that you directly get into trouble but often leads to that DOJ looks into the case. If DOJ determine that they can claim money back from companies or hospitals they will act.

A typical case:

In case of warning letters due to promotion or advertisement (often off label claims = not within intended or indication for use) DOJ often can find wrongly assigned reimbursement codes. If they find this they will claim that money back. And trust me, if you think FDA can be difficult to handle in a non-compliance situation, that’s a walk in the park vs DOJ! In the future I will show several cases in the blog.
One example on this!

The connection to MDR?
In the past promotion and advertisement in Europe have been a national regulation if regulated at all for B2B type of transactions. With MDR this change completely, now it will be the law in all EU countries. The rules can be found in article 7 copied below:

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by:

(a) ascribing functions and properties to the device which the device does not have;

(b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose;

(d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Who will this apply to?
The rules could apply to most economic operators. The manufacturer, importers or distributors are probably the ones that most likely could get into trouble if they do not have this under control. However currently the reimbursement system does not have the direct relation to intended use why the monetary penalties most likely will be tied to harm instead. Enforcement will most likely be on national level due to language used.





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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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Regulations around the world

Regulatory AffairsPosted by Peter Mar 03, 2019 12:59:15
We often get questions on what requirements there are in certain countries. Not that easy to answer since this clearly depends on what product you have! What we know for sure there are changes ongoing all the time. To much regulations will have negativ effect on the average health index in the world, and small vountries might not even get any manufacturers entering the market. WHO publish reports about regulations on an overall level. The latest we know about are from 2016. The below picture can be found there, explaing what out of 3 main factors exist in the country.



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Long life vs how much we spend

OtherPosted by Peter Mar 03, 2019 12:44:51
Interesting to read statistics sometimes. According to the statistics it is not always better to spend most money. US clearly sticks out. Would be interesting to know factors behind this, both for ”how to avoid” but also things we work with, approval process, reimbursment systems and private vs public systems. This specific data is from ourworldindata that are several universities in the world working togheter.


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