Coming right to the point –Brexit again. The UK published its proposal for law, which will have to be in effect in case of a Brexit without a deal (hard Brexit). It is our understanding that the Parliament will have to vote on it and upon that needs to be implemented. The basis is the MDD but be aware it is not a consolidated version. This is the most difficult reading. On page 3 we find the definition of the UK responsible person (UK RP): “UK responsible person” means a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.”
MDSS considers to establish a UK entity for you to deal with this new UK RP requirement. Transitional provisions are provided by the MHRA to ensure a timely implementation.
First Notified Body appointed for the MDR!
The first notified body has received its accreditation for the new European Medical Device Regulation (EU) 2017/745. Thus, manufacturers can now theoretically have their devices certified according to the new regulation (MDR). The first notified body is UK based BSI.
However, if this spring (2019) the hard Brexit should occur, which at this point seems possible, certification by a British notified body would probably no longer be acknowledged in the EU, as mentioned even by MHRA.
BSI Group The Netherlands B.V., an entity founded in the Netherlands by BSI as safe haven for affected clients following a hard Brexit, already has an accreditation according to the current Directive 93/42/EEC, as of today (January 23, 2019), still has not been appointed for the new MDR.
It seems very probable that within a short time, at least one more notified body will be appointed for the MDR.
It is worth keeping an eye on the accreditation progress, and inquiring with your notified body about their schedule. It is essential for manufacturers to be prepared, in order to be able to submit an application for MDR certification in a timely manner.
MDSS would strongly recommend to submit the MDR application as quickly as possible in order to get in line for the MDR certification. Once you have applied you may then set the assessment date to your needs. Should you be late you may not receive the date you would like.
There are a number of other aspects to consider. All of them are going to be addressed during the MDR workshop. This will enable you to come up with the best strategy. Therefore, we hope to see you in San Jose.