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News and Views May 2016

1.    Status of the new regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR)
2.    Major changes for the upcoming MDR (Medical Device Regulation)
3.    Major changes for the upcoming IVDR (In Vitro medical Device Regulation)
4.    Transition period
5.    Strategy


1. Status of the new regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR)
The long awaited new Medical Device Regulation may now soon be implemented.  The process in Europe where the Commission, the Council and the Parliament were seeking a compromise came to an end last week.  These talks were informally conducted and the actual political process needs to take place in order to implement the regulation. Please see the press releases here:
By the Council:
http://www.consilium.europa.eu/en/press/press-releases/2016/05/25-medical-devices/?utm_source=dsms-auto 
http://www.consilium.europa.eu/en/policies/new-rules-medical-in-vitro-diagnostic-devices/
BY the EPP a political Party from the Parliament
http://www.eppgroup.eu/press-release/Medical-Devices-law-strengthened?usebuid=7643
It is not expected that there will be any changes along this political procedure.  The final wording has not been published yet.  Only another outrage of patient being harmed may delay this upcoming law making process.  If everything goes according to the book, a timeline of 4 to 6 months has been communicated.  

2. Major Changes for the upcoming MDR (Medical Device Regulation)
·    The active implantable medical devise directive (AIMD) will be integral part of the new MDR (Medical Device Regulation)
·    The “economic operators” like “importer”, “distributor” and “authorized representative” and their responsibilities are in detail defined and clarified.  Will this cause more regulatory exchange among these players?
·    There are detailed requirements for clinical data, clinical investigations, clinical follow-up, vigilance and post market surveillance including integration of MEDDEV requirements
·    The notified bodies (NBs) must be “re-notified” for the new regulation.  Will your NB be one of them and if so will they still have the scope you need them for?
·    Besides existing marking and labelling requirements, the use of the Unique Device Identification (UDI) system will be mandatory.  
·    Reusable instruments formerly class I will be risk class IIa.  Will there be other reclassifications due to other clarifications?
·    High risk class devices will be scrutinized by an expert panel.  Would this expert panel challenge the clinical evaluation you have currently in place?

3. Major changes for the upcoming IVDR (In Vitro medical Device Regulation)
·    The transition from a “list-based” to “risk-based” classification system will make many “in vitro diagnostic devices” eligible for conformity assessment by notified bodies 
·    Beside existing marking and labelling requirements the use of the Unique Device Identification (UDI) will be mandatory (see UDI system for more details)

4. Transition period
The transition period is 3 years for the MD and 5 years for the IVD.  What this means is not clear as of yet.  Will you be able to get certified in the last minute according to the current directive? Can you sell the products beyond the due date with a valid NB certificate of another three years on hand?  You may also ask yourself whether your customers will prefer a manufacturer that complies with the new and stricter regulation.

5. Strategy
There is certainly no limit on the various strategies you may apply but we also would like to give our view to our clients.  There are a lot of changes to consider and some players were of the opinion that the manufacturer should have started with this process.  How can this be done if there is no final text?  Therefore the following should happen:


·   Evaluate the compromise text and educate yourself on the interpretation. The text should be published soon.

·    Wait for the final law to be published

·    Start immediately with the implementation of any changes which may apply to you.  For example, if you are the manufacturer of a product where the classification of the product change (reusable instrument or IVD), it would be advisable to implement the conformity assessment procedure early enough. Search for the NB who is already a NB according to the new regulation.  This could become critical if the resources are not available with the NBs.

·    In any case get the NB plan to audit you for the new regulation as early as possible
Overall if someone has a good product, a good conformity assessment system in place and the technical documentation have been kept up to date should be able to comply with the new regulation in due time.  However, if this is not the case then we recommend hurrying up.

Here is the link to the council website where the texts can be found which were the basis for the trilogue meetings.  
These are not the final texts.  
http://www.consilium.europa.eu/en/press/press-releases/2015/06/19-medical-devices-council-ready-talk-with-ep/