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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