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Regulations around the world

Regulatory Affairs Posted on 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.

Long life vs how much we spend

Other Posted on 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.

FDA plan to introduce ISO 13485 this fall

FDA/USA related Posted on 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 letters

FDA/USA related Posted on 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 on 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 2019

Regulatory Affairs Posted on 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

And the latest follow up report from 2017 can be found

Brexit-EU guidance

MDR/EU related Posted on 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

Brexit and Notified bodies

MDR/EU related Posted on 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.


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!


FDA/USA related Posted on Feb 26, 2019 08:03:01

FDA publish many guides but also training material online. They have several videos explaining the regulation and implementations but also PPt in all kind of subjects. At below link you find some of the material. A good starting point! Unfortunately they withdraw the gudie for small manufacturers with examples on how to meet QSR. This can howeveer be found at other placed.

Brexit and EUs Q&A for medical device manufacturers

MDR/EU related Posted on Feb 26, 2019 07:54:46

1st of February 2019 the EU comission published


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:

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