Certification news

The European Commission has published, as of 1 September 2021, a recommendation to Market Surveillance Authorities (MSAs), which may have impacts for PPE Manufacturers, as follows:

  • From 01 October 2021, MSAs are recommended to no longer authorise (EU) 2020/403 PPE where (EU) 2016/425 compliance has not been demonstrated;
  • Until 31 May 2022, (EU) 2020/403 PPE placed on the market for general use may continue to be made available;
  • Until 31 July 2022, (EU) 2020/403 PPE placed on the market for use ‘in the efforts to contain the virus’ (e.g. medical, first responder use) may be used;
  • From 01 August 2022, MSAs are recommended to continue to focus on PPE, checking for correct CE marking and compliance with (EU) 2016/425.

It should be noted that this document is a ‘Commission Recommendation’, the legal status of which users must determine for themselves.  

The UK has now left the EU, and while a trade agreement was confirmed it did not include a Mutual Recognition Agreement on product conformity legislation.

Procedurally, the UKs new UKCA and UKNI marking (replacing the ‘CE Mark’) and Ensign marking (replacing the 'Wheel Mark’) are expected to be the same.

Throughout 2021 existing marking to EU requirements will be permitted, but manufacturers should begin to update / obtain the new marking for the UK markets of Great Britain and Northern Ireland.

Please review the Certification pages of this website for more details on schemes offered, requirements, and contact details.

on market surveillance and compliance of products and amending Directive 2004/42/EC
and Regulations (EC) No 765/2008 and (EU) No 305/2011

Responsible EU economic operator

Proper legal opinion is needed to understand this regulation, however in our lay reading of the document:

It applies from 16 July 2021 – meaning manufacturers must have arranged to meet the requirements before this date.

There must be an ‘economic operator established in the Union who is responsible’ for:

  • Verifying that there is a manufacturer EU Declaration of Conformity (DoC);
  • Retaining the manufacturer EU DoC for 10 years;
  • Having a method by which they can arrange for technical documentation of the manufacturer to be presented to market surveillance;
  • Providing above documentation in a language easily understood;
  • Informing market surveillance if they believe PPE is nonconforming and presents a risk;
  • Working to support market surveillance in any market surveillance activities regarding the products.

This can be the manufacturer (if based within the EU), an importer, an authorised representative, or a fulfilment service provider.

It does not appear that this can be the end user – i.e. someone who buys for their own (or staff) use.

The Marine Equipment Directive already requires this, via the authorised representative rules.

INSPEC operations during the coronavirus Covid-19 pandemic

Our offices throughout the world are adjusting to the changing landscape presented by the COVID-19 pandemic. INSPEC will continue to make appropriate arrangements for all staff on a personal and regional basis, and where possible continue to serve our customers.

At times our staff will be home-based and office-based, but will remain in contact via email, and may arrange web-based communication when necessary and possible.

We do expect continued disruption to services however, and thank you all for your patience and understanding during this challenging period. 

Note from Certification Department

Following the World Health Organization classification of COVID-19 virus as a pandemic, our ability to make customer visits and perform certification audits has be affected significantly.

Conditions and limitations on travel from origin and destination governments around the world make the process of confirming site-visits impossible, but we now have a fully implemented remote auditing process.

INSPEC staff will maintain contact with our certificate holders who are due audits / visits, with the aim of fulfilling these as scheduled via this remote service.

If and when travel becomes easier, INSPEC staff will consult the UK Foreign Office website for travel advice as part of overseas visit planning, and again immediately before undertaking any pre-arranged travel.  

If you have any COVID-19 controls in place, or restrictions upon external visitors, please let us know in advance – and as any details change – before any visit.  

INSPEC has held discussions with other certification organisations, Approved Bodies and and European Notified Bodies on the possible approaches for maintaining certification for customers, should audits / visits have to be postponed.  

We understand these options include, but are not limited to, the following:

  • An extension to certificates which are due to expire during the extraordinary period;
  • Remote auditing by means of camera or other teleconferencing technology;
  • Remote auditing by means of desktop review of data packages (e.g. production records);
  • Production sample testing.

These discussions will be on-going with our industry counterparts. 

Should alternative methods of maintaining certification be required, these will be considered on a case-by-case basis with customers, before a decision is made.