News & Views, January 2019 - Update

2019.01.14

• MDR
• Brexit

MDR 

The MDR is kicking in! On occasions, it was not possible to download files from the European Union website.  We assume that with the beginning of the year, MDR/IVDR projects were initiated and, with the most important step to get the right information, the EU website was crowded for a few days. 

Brexit 

The big day is tomorrow January 15. We will closely monitor the UK Parliament outcome.

The MHRA has issued additional information/requirements in case of a hard Brexit. Here is the link. It should be noted that the MRHA indeed sticks to its promise to provide ample time for manufacturers to adjust. The good news are that products with a valid CE mark may be placed on the market for the time being without any changes in terms of the conformity of the products. This may change in the future, which is subject to consultation.  

The main change to note is a new notification requirement for all risk class products. The critical aspect is the notification expectation of only 4 months for Class III medical devices, Class IIb implantable medical devices, Active implantable medical devices, and IVD List A. In addition, if the manufacturer is not situated in the UK, this registration must be performed by a “UK Responsible Person”. For other products, there will be an 8 and 12 months’ timeline, based on their classification respectively.

However, before someone may act on these new requirements, the following three options may happen:

• 
  
  We need to understand that this applies only in case of a hard Brexit on March 29, 2019 at 11pm!
• 
  Additional time will be given until December 31, 2020 if the Parliament agrees on the DEAL with the EU.  No changes will happen during this additional transition. The purpose is to negotiate a meaningful trade deal, which hopefully will be positive for medical devices, avoiding any additional requirements (e.g. agreement on the use of Eudamed, which would eliminate a separate registration).  
• And the last option is still that the Brexit will not happen at all and this may develop before March 29, 2019.

Once there is more clarity (hopefully by tomorrow) we will act accordingly.  

In case of a hard Brexit, MDSS is committed to install a UK Responsible Person to support its clients who wish to have an independent entity taking care of the registration. We are confident that with the knowledge of all the other European databases, we will be able to feed the data into the databank quickly.  Furthermore, we will directly inquire with the MHRA for the legal basis to determine the exact requirements for the notification of products and for the UK Responsible Person.

We are looking at an interesting start of 2019.  News are coming, and it is always important to verify them with the sources (see above link), as we often notice that news are tweaked and used in a manner which may cause someone to act upon it prematurely.  

In any case, please proceed with your MDR implementation process and contact MDSS should you have any questions and join us at our workshops.