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News and Views March 2017

•    New Regulation

•    Entry into force and date of application (Article 123)

Dear Customer,
Dear Partner,

New regulation

Just recently the council published its version of the regulation.  The council is the European institution in Europe which represents the member states.  We should not go through the details of the European lawmaking process.  Just this much:  the published document is not final - the Parliament being the legislative arm of Europe must vote on it with its own separate process.  Could there still be some changes?  Most likely not: No one wants to work on this anymore.  There is no fame to be achieved.  
We have lobbied to remove the Authorized Representative (AR) liability requirements and we have received great feedback on various levels and from all areas with an enormous understanding that AR liability is not a good idea.  It seems to that this is known but they all bite their tongue:  Without any need a new costly aspect is introduced without gaining any benefit for the patient (it makes it even more complicated) and there is a high possibility in decreasing the system for protecting the patient safety (PMS and Vigilance).

Here are the links:
The NEW CE MARKING for medical devices – the ALMOST final MDR & The NEW CE MARKING for IVDs – the ALMOST final IVDR
The final version is expected within weeks and not months anymore!
In any case since there are no (major) changes to expect we recommend starting now implementing the new regulation.  Here is why:

Entry into force and date of application (MDR Article 123)
Article 123 1. First sentence:
“This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.”

Sounds scary?  Enforcement! It is the start of the transition period.  During the transition period the manufacture must apply the regulations in order to be able to continuously place products on the European market.  

So when does the transition end?
Article 123 1. Second sentence:
“It shall apply from … [three years after the date of entry into force of this Regulation].”

So, if published in the Journal for example on Mai 1 then the regulations come into force on May 21 and will be applicable in May of 2020.

This means all products must fully comply with the new regulation on May 2020 with a few exceptions with a lot of restriction.  

Exceptions are for products with a valid notified body certificate. Here we have to be clear: the exceptions apply not for risk class I products and if products are reclassified then they must be certified by that date.  Worth mentioning is that reusable surgical instruments will be still of risk class I but they also must be certified by that application date.

IVD Manufacturers have a transition period of five years (IVDR Article 113).  This may not help since a significant number of products (about 80%) must be certified because they are considered of higher risk.  The certificate for those products must be in place when the IVD Regulation is being applied.  There are similar exception for products which are certified but they are more restrictive.  

To be continued soon with the exception due the certificates:

Your MDSS Team

Disclaimer:  Always refer to the regulation, directive or whatever original law and come to your own conclusion what is required for your products