As many of our clients are aware, on the 19th March, The CE Marking Association adopted a ‘Work From Home’ policy in line with Government Guidelines at the time. This involved a total closure of our offices and a partial closure of our laboratory; the latter being opened only upon demand and where it was safe to do so.

Whereas we continue to work from home wherever possible, the Government has asked businesses to start planning for a phased reopening. In our case, this involves a more structured opening of the laboratory and provision for our offices to partially open where it is not possible for work to be carried out remotely.

Unfortunately, we are still not in a position to invite visitors on-site and therefore training and consultancy will still take place remotely, we can however invite clients to deliver and collect products for testing within strict social distancing guidelines. we can still offer witnessed testing, however this would be via a ‘Microsoft Teams’ remote meeting.

We have published our Risk Assessment here detailing how we plan to achieve this and would ask all clients to read this if they intend to submit products to our laboratory for assessment.

If you have any questions regarding our Covid-19 phased return policy, please call us on 01564 792349

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UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment 

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Subsequent to our previous post regarding the CE Marking of surgical masks used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist Manufacturers in getting their products into the field.

The Medicines and Health products Regulatory Agency (MHRA) has issued guidance for Manufacturers seeking a derogation from carrying out the full conformity assessment process in the interests of public health.

The guidance invokes a derogation within the Medical Devices Directive allowing the Regulatory Authorities to take such action  where the threat to human health warrants it.

Please be aware that this Derogation does not apply to PPE. Manufacturers of PPE seeking should read the guidance offered by the EU Commission and in particular this commission recommendation and the guidance offered by the Uk Government Any queries regarding placing PPE on the market should be directed to the UK Department of Business, Energy and industrial Strategy (BEIS). 

Some Frequently Asked Questions regarding the supply of Medical Devices and PPE during the Coronavirus outbreak have been included below.

Is my face mask a Medical Device or PPE?

This depends on the intended use of the mask. If the intention is to protect the patient, the mask is a Medical Device; if the intention is to protect the wearer, it is PPE. the majority of face masks being currently used during the outbreak are PPE.

What certification should I look for when I am buying face masks?

There is no ‘certification’ as such; compliance is demonstrated by the manufacturer. You should look for a ‘Declaration of Conformity’ referencing the legislation as above. Medical Face Masks are classified as ‘Class I’ Medical Devices and as such do not require third party assessment. Face masks used as PPE are classified as Category II (Face masks) or Category III (Respiratory Protective Equipment (RPE)) and will require third party (Notified Body) assessment, the name of this Notified Body should be listed on the Declaration.

What Standards should I use to manufacture my face masks?

The applicable Standard will depend on the product itself; Medical face masks (visors) should conform to EN 14683. In terms of PPE, EN 166 applies to face masks, EN 149 applies to half face RPE and EN 136 applies to full face RPE. For body protection, EN 14126 applies to full body overalls. It is important to stress that Standards are not compulsory, however they do offer good confidence. 

What do the current derogations mean to suppliers?

The current derogations ease pressure on the supply chain by allowing healthcare authorities to procure products which have not gone through the formal assessment. However they must still be fit for purpose and safe. The derogation puts the responsibility on the buyer to procure safe equipment.

How do I find a Notified Body for my face mask?

The derogation also puts an obligation on Notified Bodies to prioritise equipment required during the outbreak. Notified Bodies able to carry out assessments against the Medical Devices Directive can be found here and those able to carry out assessments against the PPE Regulations can be found here

The CE Marking Association yesterday (25th March) held a special seminar aimed at helping manufacturers understand their product compliance requirements as the UK moves out of the current Implementation Phase following its departure from the EU.

The Seminar was held in slightly unusual circumstances due to the current restrictions imposed as a result of the COVID-19 outbreak. However, this did not detract from the excellent key note speach given by our Guest Speaker; Abi Gambell from the UK Government department of Business, Energy and Industrial Strategy. Thank you to all whose who attended; we do offer our apologies for the one or two slight technical hitches as we embraced new technology at short notice!

A copy of the presentations is available in the Members’ area of our website. Non-members who attended will receive a copy separately.

In the wake of the current Covid-19 outbreak, the CE Marking of Surgical masks has become the most asked question on our message board. In response to this, we have looked into the product legislation that covers these items.

As with all CE Marking, one of the key questions when determining the relevant legislation is that of the ‘Intended Use’ of the product; and Surgical masks are no different. there are essentially two pieces of legislation under which they may fall:

If the mask is intended to protect the patient, then the masks would be a Class I Medical Devices under the Medical Devices Regulations. The Regulation does not come into force until May of this year, however there is a derogation allowing it to be used in lieu of the old Directive and as such, we would strongly advise manufacturers to use the new Regulation.

However, the more pressing need for Surgical Masks is for those intended to protect the wearer – In this instance they fall under the Personal Protective Equipment (PPE) Regulations. Under this Regulation, they are classified as Category III PPE and will currently require the involvement of a Notified Body; a list of Notified Bodies can be found here. Although not mandated, best practice dictates that manufacturers should follow the guidance of a Harmonised Standard in order to enjoy a presumption of Conformity to the Regulation. The Harmonised Standard which currently applies to Surgical Masks is EN 149:2001 + A1:2009.

For further help and advice regarding Medical Devices or PPE, please contact the CE Marking Association

Marking Association on 01564 792349

The current Covid-19 outbreak places a collective responsibility on industry to minimise impact to key services whilst at the same time supporting business continuity through this difficult time. To support this, the CE Marking Association will take the following actions which we hope will minimise the impact on our customer base. These changes will be in effect from the end of business on Thursday 19th March and will be until further notice.

• Where possible, our staff will be working from home, we have remote access to our switchboard so please continue to telephone as normal, however if you wish to speak to a particular member of staff, please understand that we may have to telephone you back. Email services will continue as normal.
  
  
• We will continue to offer our consultancy services; both those which are already booked and any potential future services. Please be advised though that we will offer this as a virtual service using, wherever possible, Microsoft Teams. If you currently have consultancy booked with us (including members’ face-to-face sessions) will will contact you separately to make arrangements for this
  
  
• We will continue to deliver both public and private training courses however we will deliver these remotely, again via Microsoft Teams. This offers the advantage that we can deliver the course to delegates in multiple different locations. Please contact us if you feel we can assist you with your training needs during this hiatus. Again, if you currently have a booking with us, we will contact you separately to make arrangements
  
  
• We intend to keep our EMC lab open – we are able to operate this service safely and at present intend to honour existing bookings and take additional bookings. Please be aware, however that we may have to schedule work should any of our staff need to self-isolate.

Please be aware that although we will endeavour to meet our existing time committments, there may be situations where we need to reschedule work in order to meet individual staff needs. We apologise in advance for this and thank you for your understanding.

We look forward to supporting you through this difficult period, if you have any queries, please call us on 01564 792349