The EU Commission issued a 7 page notice on January 10, 2018 titled: ‘Withdrawal of the United Kingdom and EU Rules in the field of industrial products’
This notice clarifies that after March 30th 2019 the UK becomes a Third Country (NON-EU Country).
The consequences affecting non-EU manufacturers are:
- UK office based Authorized Representatives service providers will no longer be recognized in the EU. [MRM is not affected because we are office based in The Netherlands.]
- UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the EU System (NANDO). UK Notified Bodies will no longer be able to perform assessments and any certificates they issued will need to be replaced by a non-UK Notified Body.
Products affected by this include the following:
- Medical Devices
- Active implantable devices
- In-Vitro Diagnostic medical devices
- Personal Protective equipment
- Pressure Equipment
- ATEX Equipment
and many others.
Actions to be taken:
- Check if your UK Notified Body or test house has opened an office in another EU Member State.
- Check if your UK Authorized Representative has an alternative plan.
- If not: Contact our Dutch office for support.
Many manufacturers will be wondering if this is a BREXIT negotiation tactic by the European Commission? No doubt it is and the words ‘subject to any transitional arrangements’ do appear in this European Commission notice.
However the real question is: Do you want to stake your EU sales on these negotiations?