Regulation (EU) 2016/425 PPE - UK Gov intends to extend acceptance of CE for PPE Indefinitely

Daithi Galway

Starting to get Involved
Hi there, I am working with a PPE company who are CE marked for a Class I product. They have been working on a plan to self declare UKCA certification and compliance.

Recent developments from the UK Gov - gov.uk/guidance/ce-marking#full-publication-update-history

Previously they were going to need to designate a UK Authorised Rep as they dont have a presence in the UK (they are based in Dublin, Ireland).

From the link, they only refer to the manufacturer or their authorised rep within EEA. They don't mention GB rep or UK AR.
This PPE manufacturer is based in Dublin, they are the authorised rep essentially for their EU market. Do they need to do anything else for the UK market?
Its PPE, do they need to register with MHRA?

Thanks

Daithi
 

CharlieUK

Quite Involved in Discussions
The manufacturer does need (can't really have) and Authorised Representativem (AR) for the EU as they are already in the EU, so there is nothing for the AR to be delegated under PPE article 9.

If the manufacturer is in the EU, and there's no UK AR then the UK importer takes on the responsibility for ensuring that the appropriate conformity assessment has been carried out and that they have compiled the Technical File. This is difficult for them to do, so an EU manufacturer may choose to appoint a UK AR to take on this responsibility and remove it from the Importer.

Charlie
 

Daithi Galway

Starting to get Involved
Cheers Charlie.
Correct. Their main HQ for Europe is Dublin, no need for a EU AR. They do have a small entity in the UK like a retail outlet, so they were exploring whether they could be their AR. But its not black and white unfortunately (it never is!). I think your option of designating a stand-alone UK AR might be the cleanest option.
Reading through the uk.gov websites, its not particular clear yet, there is some conflicting information. The link above only talks about CE requirements and having a AR designated in EEA and Turkey.
What do you think is going to happen with respect to Medical Devices CE? Indefinite extension too by UK Gov? I have already supported some UKCA certs for medical device companies, easy process if the med device company has MDR 2017/745, it was just an abridged process with BSI.
Thanks
Daithi
 

CharlieUK

Quite Involved in Discussions
The latest information that I've seen on Medical CE/UKCA is Implementation of the Future Regulations and is different to most other UK Regulations
Note: the proposed extension beyond 31 Dec 2024 is currently only a statement / press release from UK BEIS and is not supported by draft legislation let alone actual legislation
Charlie
 

Daithi Galway

Starting to get Involved
Nice one Charlie. We cant really say interesting times ahead, I think we are in interesting times right now.
thanks again
Daithi
 

Daithi Galway

Starting to get Involved
Thanks dgrainger, I will check the link out. They have a couple of variants of their eyewear, one which is PPE and the other can take a prescription lens. But they don't supply the lens.
Take care
Daithi
 
Top Bottom