The recent BSIF webinar on the UKCA Mark and what it means for the PPE industry was very well attended and yielded a lot of questions. BSIF have now provided answers to those questions, please see below, all questions are answered based upon current understanding and may be subject to change. Some questions have been edited for clarity purposes only:
| Question | Answer | |
| ‘Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended’ | For GB Market ‘Regulation 2016/425 on Personal Protective Equipment as brought into UK law and amended’ For NI Market ‘Regulation EU 2016/425 on Personal Protective Equipment’ | |
| If a product is produced and is in stock in the UK with a CE mark with a UK notified body, prior to the 31/12/2020 can this still be sold to the EU from 01/01/2021? | Yes, it can also be sold in the UK but not into the EU without the files being held by an EU NB, but by 1st Jan 2022 must also be marked with UKA following any releavnt assessment process required | |
| What can the CE marked PPE be used in UK after 1st Jan 2022? | No New CE marked product can be placed on the UK market unless it is UKCA approved. If it is existing product placed on the market prior to 1st Jan 2022, you can still sell this product – if assessed to UKCA, you will need to add the UKCA mark to the packaging | |
| If a manufacturer still has CE certification with a UK based Notified Body after 1 January 2021, can the product still be manufactured and sold in the UK or Europe?? | No, the product will need to be assessed and certified by a Notified Body within the EU 27 countries. Most UK Notified Bodies have offcies in the EU countries, so you may be able to have your certification transferred to their EU office – we would recommend contacting them urgently to get this under way. | |
| Is CE marking recognition until 23 only for medical devices or across the board for PPE? | This is Medical Devices only | |
| Gov.UK says that CE Marks can continue to be used up to Jan 2022, but your presentation showed June 2023. Is there a reason for the difference? | This is Medical Devices only | |
| There are a number of UK NB that have now offices in Europe but the work is really done in the UK? Will this still be possible? | The arrangements that the EU established Notified Bodies have agreed with the national notifying authorities are acceptable to the Commission | |
| If the product is non a safety standard product and doesn’t require PPE certifications it only need CE mark? | The manufactured goods which will require UKCA marking are those controlled by the legislation identified. It is a useful rule of thumb to assume if there was previously a requirement for CE there will be a future requirement for UKCA / NI | |
| If we have to use BS EN for UKCA will the EU insist it is just EN standards | All EN standards that are harmonised are officially published in the UK with the prefix BS (in Germany it would be DIN) the designation for the product will be EN followed by the standard | |
| What about the validity of EC-type certification certificates released by EU notified bodies before Jan 1st 2021? | EU Notified Body controlled certificates remain valid till their expiry date but that does not remove the need to have UKCA for GB | |
| Regarding selling into the EU what does this “Responsible Person” actually need to be? | A person or a company established in the EU |