UPDATE: I’m sure you are now aware of the latest developments around Brexit and the Withdrawal Agreement that the UK Government has agreed with the European Union. At the time of writing (22^nd October) the UK parliament is debating the Withdrawal Act that will legally implement the Withdrawal Agreement. We look at this Act may affect your CE Marking Obligations

The Key Section of the Act is Section 2(2) which states “EU-derived domestic legislation, as it has effect in domestic law immediately before exit day, continues to have effect in domestic law on and after exit day […]”. This is complimented by Section 2(4) which adds “Any EU-derived domestic legislation which is an enactment passed or made on or after exit day and before IP [Implementation Period] completion day is, unless the contrary intention appears, to be read in accordance with subsection (3)”.

The effect of this legislation is that if the Act is passed into law, current CE Marking legislation whether in the form of UK legislation (Directives) or directly imposed EU law (Regulations) will continue to be law in the UK until the end of the Implementation Period (The period during which the two parties have agreed to negotiate a Trade Agreement ending in December 2020). Therefore your obligations as Manufacturers, Importers or Distributors will not change until that time.

The provisions made within the Act for the period following the Implementation period are a default position only and implantable only if a Trade Agreement is not reached in that time.

The CE Marking Association will continue to follow the Brexit process and consider its effects on CE Marking for UK Manufacturers; we will publish updates as they become available however if you wish to discuss any topics related to CE Marking, then please get in contact.

Over 100 people attended the two CE Marking Seminars given at the Northern Manufacturing Show earlier this month which looked at the CE Marking process in general as well as exploring recent or imminent changes to legislation and of course, Brexit!.

Members of our Technical Team were on hand to help and advise both before and after the seminars. If you are interested in ongoing support for your CE Marking requirements, we offer membership of the CE Marking Association, details of which can be found here.

We look forward to welcoming you at similar events in the future, please keep an eye on our website for details of future seminars.

A copy of the presentation can be found here (.pdf – 4.0Mb)

The Northern Manufacturing and Electronics show is a large exhibition that is hosted every year by ETES (European Trade & Exhibition Services). This year the two day show is being hosted on the 2^nd & 3^rd October at Event City (Manchester, M17 8AS) and we are happy to announce that ETES have invited the CE Marking Association to provide two seminars on CE Marking in 2019 and beyond.

Tim Harrison, Engineering Manager of the CE Marking Association, will be presenting a FREE seminar covering an overview of the CE Marking process and then looking at recent and forthcoming changes – including, of course, the impact of Brexit on product compliance obligations. Tim will be presenting his seminar at 10:15 on the 2^nd October and 11:20 on 3^rd October, giving visitors a fantastic opportunity to speak to him about their CE Marking requirements. 

The show and seminars are free to attend and there is free parking on site.

We hope to see you at the show!

If you are keen to attend the show and our CE Marking seminars, then please register today on the ETES Industry North website: http://www.industrynorth.co.uk/

If you would like to follow up any CE Marking questions, then please feel free to get in contact on 01564 792349

The Restriction of Hazardous Substances (RoHS) Directive (2011/65/EU) is a CE Marking Directive which focusses on managing the health and environmental impact of hazardous substances by Manufacturers within the EU.

The Directive, commonly known as ‘RoHS II’ is an extension of the original RoHS Directive 2002/95/EC and added five additional categories of equipment phased in from July 2014. The final category; Category 11 ‘All other EEE’ became applicable on 21^st July 2019 meaning that all EEE unless excluded now falls under the scope of RoHS. Exclusions from RoHS include:

• Equipment for military use or other essentials interests of the member state
• Equipment designed to be sent into space
• Equipment intended to be installed into other equipment which is itself excluded
• Large scale stationary tools
• Large scale fixed installations
• Means of transport for persons or goods
• Non-road mobile machinery
• Active implantable medical devices
• Photovoltaic panels
• Equipment design solely for purposes of research and development

Simplified list, see the Directive for the definitive list

An amendment to the RoHS Directive (often misquoted as RoHS III) has been published which adds four more materials to the restricted list. The CE Marking Association has published an article about this here, however Manufacturers should be aware that this is not a new Directive and that Declarations of Conformity should still refer to 2011/65/EU

If you need any help and support with CE Marking under the RoHS Directive, then please call us on 01564 792349

The three pieces of CE Marking legislation covering Medical Devices; The Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC) are soon to be replaced with two new Regulations.

The Medical Devices Directive and Active Implantable Medical Devices Directive are to be merged into a new Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Directive will be replaced by a new regulation (EU) 2017/746. The new regulations will come into force on 26^th May 2020 (2017/745) and 26^th May 2022 (2017/746); the UK Government has committed to implementing the new Regulations regardless of the outcome of Brexit.

The main changes from the old Directives focus around Technical Documentation with a greater emphasis put on documenting Post Market Surveillance and an increased robustness in the validity of clinical data required.

Notified Bodies will lose their notification under the old Directives on 26^th May 2020 (93/42/EEC & 90/385/EEC) and 26^th May 2022 (98/79/EC) by which time they should apply for notification under the new Regulations. However Notified Body certificates issued after 25^th May 2017 against the old Directives will be valid for the period indicated on the certificate or until 27^th May 2024; whichever occurs sooner.

By way of derogation, Manufacturers may place devices on the market which comply with the new Regulation immediately, however as at the time of writing, only two Notified Bodies hold notification under 2017/745 and none under 2017/746, in practice, this may only apply to devices requiring no Notified Body involvement.

If you need any help or support with CE Marking under the Medical Devices Directive, then please call us on 01564 792349