Certification news

REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019
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 Certification Services operations during the coronavirus Covid-19 pandemic

Our offices in Shanghai and Taipei are now working normally.

On 16 March 2020, the UK Government advised companies to arrange for employees to work from home where possible.  Consequently, INSPEC Certification Services department made appropriate arrangements and our UK-based certification staff are now working from home.

Our staff will remain in contact via email, and may arrange web-based communication when necessary and possible.

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


CORONAVIRUS COVID-19

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

Indeed, with the limitations on travel now being placed by governments around the world, our overseas audits are being curtailed already.  

INSPEC staff will maintain contact with our certificate holders who are due audits / visits, with the aim of fulfilling these as scheduled.  But there is a possibility that domestic visits and audits may have to be postponed at short notice, because of expected UK government decrees. 

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 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:

  • A six-month 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.

BREXIT UPDATE – 2 DECEMBER 2020

PPER - Don’t delay - Transfer today

All customers were invited in November to transfer PPER certification to INSPEC BV NB 2849 and the process is well underway.  However, we urgently need all outstanding signed Transfer Letters to be returned to us no later than 18 December 2020.

The closer their arrival to 18 December 2020, the less likely we will be able to complete the internal administration and issue the Certificate Letter in response.

Common reasons for delay:

  • Unsure which models to maintain:
    Don’t worry, transfer is free and you can terminate in 2021 any certification not needed;
  • Unsure you will have UK market access:
    Don’t worry, the UK Government has said ‘CE’ will be accepted until 31 December 2021;
  • Your Head Office address has changed:
    Don’t worry, we will recognize the change and reflect it in the Certificate Letter.

Consequences of DELAY and MISSING free transfer:

  • Production of INSPEC UK NB 0194 certified PPE and ‘CE’ marking must stop from 1 January 2021;
  • Access to the EU market for new production is lost.
  • Access to the UK markets for new production is lost.
  • If an OEM, all associated OBM certificates also become null and void on 1 January 2021.

If you are missing your Transfer letter (please check within your organization first for an email from BVTransfer) then email This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject heading “MISSING Transfer”.  Include your company name and list any certificates within the body of the email.

 

BREXIT UPDATE – 23 NOVEMBER 2020

Certificate Letters being issued from today

INSPEC International BV, NB 2849, is now operational under PPER (EU) 2016/425 notification.

Today we are responding to Transfer Letters by issuing the promised Certificate Letters.  If you have returned your signed Transfer Letters, there is no need to contact us, we will reply during the coming days.

You may want to begin printing User Information in the name of INSPEC International BV, NB 2849, and, if a Category III Approval Decision (Module C2 or D) holder under PPER, start tooling and applying the CE 2849 mark.  However, please note – goods so marked may only be placed on the market once you have received your Certificate Letter, and signed an EU Declaration of Conformity bearing the date of issue of the Certificate Letter.

If you are still missing your Transfer letter (please check within your organization first) then email This email address is being protected from spambots. You need JavaScript enabled to view it. with the subject heading “MISSING Transfer”.  Include your company name and list any certificates within the body of the email.  We have received some such replies, and they are being processed.

Placing product on to the UK markets (UKCA Mark/UKNI Mark)

INSPEC awaits clarifications from the UK Government, in anticipation of the closing of UK and EU negotiations. It is now our expectation that there will be new markings differentiating between Great Britain and Northern Ireland – as described by earlier UK Government guidance for the UKCA and UKNI marks.  INSPEC International Ltd will request Approved Body status from 1 January 2021, or sooner if permitted.

The CE mark is expected to be accepted until the end of 2021 for PPE.

 

BREXIT UPDATE – 02 NOVEMBER 2020

Certificate transfer to INSPEC International BV is underway

INSPEC is now issuing transfer letters, as mentioned in our bulletin of 6 October 2020 below.  Please look out for an email from BVTransfer, with a subject line “INSPEC BV Transfer . . .”.

I expect all transfer letters to be delivered by 5 November 2020.  If, by then, you have not received yours, please check with others within your organization, as it is possible that we do not have your current email address.

If the transfer letters have not been received, please send an email, with the subject line “MISSING Transfer” and your company name, to This email address is being protected from spambots. You need JavaScript enabled to view it..  Please list any certificates within the body of the email.

After you have returned your signed transfer letter, we will be able to issue your certificate letter later this month.  This should allow for a smooth transition of PPE certification before the deadline of 31 December 2020.

The UKCA Mark

There is no change to our bulletin below.  Once more is known, this webpage will be updated to keep you informed.

 

BREXIT UPDATE – 06 OCTOBER 2020 

Certificate transfer to INSPEC International BV 

During the coming weeks INSPEC will be preparing the letters to invite holders of our current certificates and projects to transfer them to INSPEC International BV. 

The letters will ask you to confirm which certificates you wish to transfer, and to indicate how long it will take you to stop using references to INSPEC International Ltd in your technical documentation and any use of ‘CE 0194’ on product. 

You will:

  • continue to use INSPEC International Ltd certification documents, as they will become property of INSPEC International BV in the future, once we confirm transfer with a Certification Letter;
  • not have to re-submit technical documentation to confirm updated references to INSPEC International BV;
  • note that there will be no charge for the transfer. 

INSPEC will also provide draft documentation to help explain the certificate status. 

This approach has been explained to all EU Member State Market Surveillance Authorities (Ad-Co) and to the European Commission, without objection. 

At this point we expect that transfers will be confirmed in December 2020.

The UKCA Mark

While the UK government has issued guidance for the marking requirements for the UK market post-withdrawal, the underlying legislation is still being revised and therefore no UK body can confirm what the requirements will be. 

We do not expect to have any more detail until the second week of November at the earliest. 

From the outset of UKCA Mark discussions, INSPEC has been arguing for:

  • the ability to release UKCA certificates and approval decisions on the strength of CE work;
  • the ability of manufacturers to apply ‘UKCA’ in the paperwork, as opposed to on the product. 

Once more is known, this webpage will be updated as the means of initially informing customers.

 

BREXIT UPDATE – 03 AUGUST 2020

I hope you are all faring well – the past few months have been a challenge for many nations, companies and individuals.

With many returning to work, customers are understandably requesting an update on our Brexit plans concerning PPE and Marine Equipment.

Despite restrictions presented by the COVID-19 threat, we are working on the necessary tasks to enable the transfer of certificates before 31 December 2020.

The plan remains:

  • Invite all customers to transfer via letter;
  • Customers define ‘a reasonable period’ during which to update to the new NB number, allowing the use of the existing NB number 0194 during this period;
  • Customers return the signed letter;
  • INSPEC International BV returns a letter certificate. Existing certificates will remain unchanged;
  • As the existing certificates become due for renewal, they may then be reissued as INSPEC International BV certificates.

This plan allows us to make the transfer free of charge to customers.

We need the email addresses of two contact persons for your organisation.  Please confirm existing contacts or inform us if there have been any changes.

 

BREXIT UPDATE – 21 FEBRUARY 2020

INSPEC International BV is now a Notified Body under the Personal Protective Equipment Regulation.

INSPEC International Ltd will continue offering Notified Body services during the Brexit ‘withdrawal period’ - until we complete the transfer of existing certificates from INSPEC Ltd to INSPEC BV.

Therefore, please be aware that we are not inviting applications to INSPEC International BV at this stage.

To make the certificate transfer process as efficient and impartial as possible, we will issue the transfer invitations to all certificate holders simultaneously.  As a reminder, it is therefore important that all customers keep us informed of email addresses of your primary and secondary contacts.

Once the transfer of existing certificates has been completed, we will invite applications to INSPEC International BV for new Notified Body work.

 

BREXIT UPDATE – 10 JANUARY 2020

INSPEC is confident that the ‘withdrawal period’ – protecting UK Notified Bodies, UK issued certificates, and the right for manufacturers to apply “CE” and “CE 0194” markings until at least 31 December 2020 – will be established between the UK and the EU this month.

This assumption is based upon The European Union (Withdrawal Agreement) Bill 2019-20, which recently successfully passed through the UK House of Commons.

 You may track the timetable here:

INSPEC is also confident that there will be several months of overlap to facilitate transfers of certifications between INSPEC International Ltd and INSPEC International BV, and for manufacturers to revise notified body numbers.

The Dutch notifying authority SZW has confirmed completion of their work, and we are now awaiting our formal listing in NANDO – which will provide the new notified body number for INSPEC International BV.  We will invite customers to transfer once INSPEC International BV is able to grant certification. 

However, please note that there may be an alternative to transferring - that is, for UK Notified Bodies to work beyond the date of UK exit from Europe, through a Mutual Recognition Agreement.  If this materializes, transfer will not be necessary and manufacturers would save costs by avoiding an update to documentation, product marking and tooling, etc.  INSPEC has maintained discussions on this possibility with the UK Government departments, and will keep customers informed as we learn more.

 

BREXIT UPDATE – 02 DECEMBER 2019

INSPEC International BV has gained conditional RvA accreditation, effective 21 November 2019.

You may find us on the RvA Accreditation website here:

INSPEC International BV may be in contact with existing customers of INSPEC International Ltd to arrange on-site activities which may be witnessed by RvA.

INSPEC International BV is now progressing Notification through SZW (PPE) and ILT (MED). 

Once INSPEC International BV may grant certification, INSPEC International Ltd will invite its customers to transfer to INSPEC International BV for activities described in its scope of accreditation.

 

BREXIT UPDATE – 29 OCTOBER 2019

The European Council has agreed a flexible extension to the date of the UK withdrawal from the EU, which was accepted by the UK Prime Minister yesterday. This means a new Brexit date of 31 January 2020, but with an option of entering a ‘withdrawal period’ ahead of 31 January 2020.

The European Union (Withdrawal Agreement) Bill 2019-20, remains the deal under consideration, the progress may be tracked here:

The European Union (Withdrawal Agreement) Bill 2019-20 aims to implement the following, which defines the ‘withdrawal period’:

The ‘withdrawal period’ ensures the continuation of UK Notified Bodies until a minimum of 31 December 2020, and all UK certificates (PPED, PPER, MED) may remain valid until at least the close of 31 December 2020.

Long before the close of 31 December 2020, INSPEC expects to have established INSPEC International BV as a notified body.

 

BREXIT UPDATE – 23 OCTOBER 2019

The European Union (Withdrawal Agreement) Bill 2019-20 has passed Second reading stage in the House of Commons, but is currently ‘paused’ as the EU has been invited to give their response to the extension request letter from the UK Government.

If an extension is given, it is expected to be until 31 January 2020 and for the purpose of allowing time for the UK to complete the Introduction and gain Royal Assent of The European Union (Withdrawal Agreement) Bill 2019-20.

The stages of a Bill starting in the House of Commons may be found here:

The progress may be tracked here:

The European Union (Withdrawal Agreement) Bill 2019-20 aims to implement the following:

If implemented, the agreement ensures the continuation of UK Notified Bodies until a minimum of 31 December 2020. Meaning, all UK certificates issued against the Personal Protective Equipment Directive (via PPER, Art 47(2)) & Regulation, and Marine Equipment Directive may remain valid until at least the close of 31 December 2020.

Long before the close of 31 December 2020, INSPEC expects to have established INSPEC International BV as a notified body.

 

BREXIT UPDATE – 18 OCTOBER 2019

The UK Government and European Union have agreement the text of the UKs withdrawal from the European Union. It consists of an amending document to the original draft Withdrawal Agreement, and the draft Withdrawal Agreement.

Text of both documents may be found via the following links:

A vote is expected to be held within the UK Parliament on Saturday 19 October 2019, to determine if this deal is accepted by UK Parliament.

If accepted, this agreement ensures the continuation of UK Notified Bodies until a minimum of 31 December 2020. Meaning, all UK certificates issued against the Personal Protective Equipment Directive (via PPER, Art 47(2)) & Regulation, and Marine Equipment Directive may remain valid until at least the close of 31 December 2020.

 

BREXIT UPDATE – 9 SEPTEMBER 2019

The European Union (Withdrawal) (No. 2) Act 2019 received Royal Assent today, having passed through the House of Commons and then the House of Lords on Friday, 6 September 2019.

In short, this law places a legal requirement upon the UK Prime Minister to request that the current Brexit date of
31 October 2019, be postponed until 31 January 2020, where a withdrawal deal cannot be agreed by the 19 October 2019.

The draft Withdrawal Agreement does contain protections for UK Notified Bodies for a transition period. This, or a similar deal, would allow INSPEC International BV to become established as a notified body and for INSPEC International Ltd to gradually transfer certifications.

A postponed Brexit date to 31 January 2020 may also make it possible for INSPEC International BV to achieve notification by this date.

 

BREXIT UPDATE – 28 AUGUST 2019 

The UK Government is urging the European Commission to reopen Brexit talks. UK opposition parties have made clear that they do not want a ‘no-deal’ scenario for the UK.  Together, this would indicate that the UK Government and its opposition are ready and willing to accept a Withdrawal deal or Mutual Recognition Agreement with the EU. 

Industry groups such as the European Safety Federation have written to the European Commission warning of the risk to industry and users within EU-27 if any action to invalidate UK Notified Body type-examination and approval decisions is taken in the event of a ‘no-deal’. 

The European Council’s draft Withdrawal Agreement contained a framework under which Notified Bodies could transfer certification over a period of at least one year. It is understood that the draft Withdrawal Agreement remains the European Commission’s offer in negotiation, and that this framework would mitigate the risk identified by us and industry groups. 

If accepted by UK Government and Parliament, this Agreement would permit maintenance of existing type-examination and approval decisions in the UK beyond 31 October 2019, and a slow but orderly transfer of them to an EU-27 Notified Body. 

A Mutual Recognition Agreement, though unlikely at this period in the negotiation, would permit INSPEC International Ltd to retain its rights to offer Notified Body Services without need to transfer to an EU-27 Notified Body. 

While we have worked diligently to establish INSPEC International BV as a Notified Body within the Netherlands for Summer 2019, we now project that this will take longer than envisioned.  We do project that Accreditation will be gained in October/November 2019, but Notification will follow after 31 October 2019. 

Where an agreement is reached, this will present no immediate problems for continued access to either UK or EU markets.  Should the European Union invalidate UK Notified Body certificates on 1 November 2019, INSPEC International BV will not be in a position to accept transfers and provide type-examination and approval decisions until Notification is granted.

 

BREXIT UPDATE – 11 APRIL 2019 

The UK Government has accepted the EU-27 offer of an exit-date of 31 October 2019, with an option of an earlier departure should a deal be reached. It is now to be understood that, should a no-deal Brexit occur, in which Notified Bodies of the UK are not permitted to provide notified body services, the exit date will be 31 October 2019. 

We understand that the draft Withdrawal Agreement remains the position from which the EU-27 will negotiate, and UK Parliament has voted in an Act in attempt to rule out a no-deal Brexit scenario. Therefore, we believe any deal will include continued Notification for UK Notified Bodies. 

It now appears likely that INSPEC International Ltd will retain its rights to offer Notified Body Services until at least 31 October 2019, or longer should the draft Withdrawal Agreement (or similar agreement) be implemented. 

It is our intention to complete the establishment of INSPEC International BV and we are confident that we will achieve this in Summer 2019. At that time, our customers will be invited to agree to transition their PPE and Marine Equipment certifications from INSPEC International Ltd to INSPEC International BV. 

Should a deal be reached wherein the UK enters into a Mutual Recognition Agreement with the EU-27, which provides for continued UK Notified Body participation within EU product legislation, transition of certification will not be necessary and existing agreements will continue. 

We believe that the political situation is now developing into more collaborative efforts which will protect the market, and consequently that our certification and hence customers’ access to the UK and EU markets will be assured.

BREXIT UPDATE – 29 MARCH 2019

The UK Government has agreed to proceed with the short extension proposed by the EU-27 in negotiation. It is now to be understood that, should a no-deal Brexit occur, in which Notified Bodies of the UK are not permitted to provide notified body services, the exit date will be 12 April 2019. This date however, is also subject to change.

There will be extensive debates, votes and negotiation during the coming weeks, but we understand that our customers are interested in their ability to place goods on the market.                                  

Please consult the following document for the latest European Commission position on how ‘placing on the market’ may be understood: https://ec.europa.eu/docsroom/documents/34622

 

BREXIT UPDATE – 15 FEBRUARY 2019 

To date, INSPEC has been implementing Brexit contingency actions for the notified body work of the INSPEC Certification Services department – namely, personal protective equipment and marine equipment certification services. Other services such as for ISO 9001:2015 and our IC Mark, and other areas of the wider business such as testing, proficiency services and test equipment sales, are unaffected. 

In brief, INSPEC Certification Services has acted to:

  • Register INSPEC International BV in the Netherlands
  • Seek accreditation with Raad van Accreditatie (RvA), the accreditation body of the Netherlands
  • Communicated with notification authorities of the Netherlands, confirming intentions
  • Communicated with legal officers of the European Commission on preparedness and interpretation
  • Communicated with UK departments on preparedness and interpretation
  • Communicated with UK notified bodies, industry and other co-ordination groups. 

INSPEC Certification Services remains confident that we will achieve accreditation with RvA, and subsequent notification with SZW for the Personal Protective Equipment Regulation and with ILT for the Marine Equipment Directive. But we cannot be certain that all of the required processes will be completed by 29 March 2019. 

Despite the arguments within the UK Parliament, UK Industry has forcefully stated that it will not tolerate a ‘no-deal’ Brexit, and we are confident that, before the withdrawal date, agreement will be reached to permit UK notified body activities to continue during a ‘transition period’.  

The European Commission expanded upon their Notice to Stakeholders[i] with the issue of “Questions and Answers Related to the United Kingdom’s Withdrawal From the European Union With Regard to Industrial Products” dated 1 February 2019[ii]

It is our understanding that, while this document and other Notices are not legislative in the form of Decisions, Directives or Regulations, they are the negotiating position of the European Commission. 

If the principles of this guidance are applied - wherein a transition period is not agreed or an agreement concerning continued placement of goods is not reached – then, after the 29 March 2019, Type-examination and Approval decisions (certificates) issued by United Kingdom notified bodies will no longer be accepted by the EU-27 Union Market. Furthermore, in contrast to earlier positions of the European Commission, all certifications will have to be reissued by an EU-27 located notified body. 

The wider global Industry is contesting the European Commission statement that UK certificates will not be accepted post-exit, as it retrospectively nullifies Type-examination and Approval decisions taken by competent bodies, which were monitored by competent accreditation authorities under instruction from relevant authorities within the UK, historically recognised by the European Union. 

However, due to the unlikely event that the Notice to Stakeholders and Q&A is implemented post-exit, we must now explain that it is possible that INSPEC may not achieve formal notification prior to 29 March 2019 - meaning the European Commission, through the EU-27 Member States, may prevent already certified equipment being placed on the EU-27 Union Market, and our PPE and MED certification clients may be without Type-examination and Approval decisions necessary for them to issue their Declarations of Conformity. 

Either through INSPEC International Ltd or INSPEC International BV, we are committed to ensuring that INSPEC Certification Services will be able to provide you with services as a notified body. We will work with you to prepare for the transition of your certification from our UK body to our body in the Netherlands as soon as we are able. 

INSPEC will continue to monitor the Brexit situation, and will inform interested parties upon request, and in response to any significant development. Updates will also be posted on our website. 

INSPEC Certification Services 

[i] https://ec.europa.eu/info/sites/info/files/file_import/industrial_products_en_1.pdf

[ii] https://ec.europa.eu/info/sites/info/files/qa_brexit_industrial_products_en.pdf

The circumstances under which a client’s certification may be suspended or withdrawn are detailed below.

  • The client’s certified management system has persistently or seriously failed to meet certification requirements;
  • The certified client does not allow surveillance or recertification audits to be conducted at the required frequencies, or prior to the expiry of their certification;
  • The certified client goes into receivership, liquidation, becomes the subject of bankruptcy laws, is convicted of breaking the law of the land or acts in a disreputable manner;
  • Non-payment of fees, or
  • The client has voluntarily requested a suspension.

SUSPENSION OF CERTIFICATION
The certification manager or technical director, in conjunction with a technical panel if deemed necessary, will authorise all suspensions either imposed or voluntary and agree/set the conditions with the client for restoration. The records pertaining to suspension will be retained in the client folder. The INSPEC certificate database will be amended to reflect the suspension. Under suspension, the client’s management system/product certification is temporarily invalid. INSPEC will inform the client of their obligations under the terms of business and to refrain from further promotion of its certification or use of marks, including where applicable INSPEC’s notified body number. In the event that a client fails to meet such obligations, INSPEC will use other measures as appropriate.
Failure to resolve the issues that have resulted in suspension in a time established by INSPEC (6 months) will result in withdrawal or reduction of the scope of certification.

REDUCTION IN SCOPE
INSPEC may choose to reduce a client’s scope of certification to exclude the elements not meeting the requirements when the client has persistently or seriously failed to meet the certification requirements. All such reductions will be in line with the requirements of the standard used for certification. The certification manager will make the decision to reduce the scope of certification and a record will be retained. The certificate database will be updated to reflect the reduction in scope. Where a reduction in scope affects product certification and the ability to apply CE marking, the client will be advised in writing of the constraints by clearly communicating the reduced scope of certification and updating all certification documents.

WITHDRAWAL OF CERTIFICATION
The decision to withdraw certification will be taken by the certification manager or technical director in conjunction with a technical panel if required, and a record kept. Upon notice of withdrawal, the client will be directed to discontinue its use of all advertising matter that contains any reference to certified status, discontinue the use of marks and where applicable the use of the INSPECs notified body number. In the event that the client fails to meet such obligations, INSPEC will use other measures as appropriate.

RESTORATION OF CERTIFICATION
Restoration of a suspended certificate can only take place after all issues have been resolved and verification of such resolution (audit/testing/other) has been undertaken within 6 months from the original suspension. Where scope of certification has been reduced instead of complete suspension of a certificate, this too can be restored following issue resolution and, where appropriate, an audit or testing/other method of evaluation has taken place to confirm and verify resolution. In all cases a certification decision will be recorded.