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Corrigendum MDR/IVDRMDR/EU related

Posted 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

Authorised representativeMDR/EU related

Posted 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.



Advertising and promotionOff/on label

Posted 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.





Status Notified BodiesMDR/EU related

Posted 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 worldRegulatory Affairs

Posted 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 spendOther

Posted 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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FDA plan to introduce ISO 13485 this fallFDA/USA related

Posted by Peter Feb 27, 2019 18:54:05

That FDA plan to change the QSR to follow ISO 13485 has been know for a while. The plan is to introduce this in the fall 2019. In a presentation made in December 2018 FDA points out that it will be a transition period partly because they need to trainbthe personnel but also that they need to revise the QSIT inspection handbook

FDA issues labelling warning lettersFDA/USA related

Posted by Peter Feb 27, 2019 18:12:36

Recently FDA have issued two similar warning letters based on promotion of products that are not cleared. In practise the companies get many different 483s because they do not have the documentation. Is this the beginnng of more strenghten control of labelling or just happen to be twice of these this month? Time will tell.
Here you find them imaging company and pouch manufacturer



FAQ MDR Transitional provisions MDR/EU related

Posted 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

Läkemedelsverket Inspection strategy 2019Regulatory Affairs

Posted by Peter Feb 27, 2019 08:54:40

Every year, normally in December, the Swedish authority are giving out a dokument explaining on how they do inspections and follow up of products in the marketplace. Overall the document explains how they work nationally and internationally both within EU but also with e.g. IMDRF countries. This gives a good picture on how authorities work together and what you can expect if you get into trouble in terms of information sharing across the world.The latest follow up document can be found here (in Swedish). The follow up report for 2018 is expected in late Q1.

The latest Inspection plan for 2019 can be found
here:

And the latest follow up report from 2017 can be found
here: