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COVID-19| Protective Equipment

Most of the equipment being used as protection against airborne particles and small droplets are covered by specific EU harmonised legislation. The vast majority of these products are classified as Personal Protective Equipment (PPE) and fall under the scope of Regulation (EU) 2016/425. These products are intended to protect the wearer.

Products that are intended to protect the patient, such as medical gloves and medical face masks, will fall under the scope of the Medical Device Directive 93/42/EEC (MDD) (to be replaced by the Medical Device Regulation 2017/745 (MDR)).

Meeting either of the above legislation will allow the manufacturer to legally affix the CE mark and circulate freely in the EU. The essential requirements of the PPE Regulation and the MDD may be met by following harmonised standards, which are published in the Official Journal of the European Union. Following this technical solution, conformity to the essential requirements may be presumed.

The following harmonised standards are applicable to face masks:

FFP-Type [PPE]             EN 149:2001+A1:2009

Medical [MD]                EN 14683:2019+AC:2019

These standards may be obtained through the following link.

The manufacturer is not required to meet all the specifications of these standards and can adopt different technical solutions. However, due to the presumption of conformity, time-to-market may be reduced drastically.

The manufacturer may decide to carry out the tests prescribed in the harmonised standards themselves or outsource this testing to a laboratory. Should the manufacturer follow these standards, the EU Competent Authorities may take a product sample and test these in accordance with the tests prescribed in the standard as part of market surveillance procedures.

Additional technical solutions and guidelines have been compiled in a list by the World Health Organisation. However, in following one of these alternative standards referred to by the WHO for PPE products, the manufacturer shall submit a sample to be tested by a designated notified body. The EU Commission has urged notified bodies to prioritise new requests for COVID-19 related PPE. In a Recommendation issued on 13 March 2020, the Commission encourages notified bodies to adopt derogations which will allow speedier market access under certain conditions.

  • Point 7 of the Recommendation allows manufacturers to anticipate the placement of their products on the market whilst the conformity assessment procedures are being finalised.
  • Point 8 of the Recommendation allows manufacturers to place their products on the market even if no conformity assessment procedures have been initiated.

Under the MDD and the MDR, medical face masks and examination gloves are considered to be class I medical devices, and as such are dependent on self-assessment and will not require notified body intervention. However, if provided in a sterile state, a notified body will be required to assess those aspects of sterility.

On the other hand, face masks and equipment used to protect against COVID-19 and are covered by the PPE Regulation are classified as Category III PPE, and thus a notified body must be involved.

In both cases, PPE and medical devices must be placed on the market with the EU/EC Declaration of Conformity document, as well as the accompanying CE Certificate issued by the notified body, when applicable. No other documents are required for market access, however, there are some additional considerations to keep in mind.

Issuing a Declaration of Conformity (DoC) signifies that you comply with that specific EU Regulation / Directive and that you have met all their requirements. Part of these requirements will be to develop and maintain a set of technical documentation.

Medical devices falling into class I, must be registered with the applicable EU Competent Authority in the country in which the manufacturer or their EU Authorised Representative is based.

For more information on how to lawfully place your PPE or medical devices on the EU market, please do not hesitate to contact us at info@advenamedical.com.

Come and Visit Advena at Arab Health 2020

At this year’s event both Advena Limited (UK) Advena Limited (Malta) will be represented. We will be located in Hall 2 Stand G15 within the UK pavilion, at this important show in Dubai from 27th to 30th January 2020.

Please do come and visit to discuss your medical device regulatory needs, whether this be our EU Authorised Representative service (EC REP) or our QMS & Regulatory Medical Device Consultancy services and how Brexit, the MDR or IVDR may affect your business and regulatory compliance activities.

We will be available to meet existing and prospective clients during this trade show.

We advise those who would like to meet one of our team to email for an appointment (info@advenamedical.com) well in advance to ensure we are available.

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director

Kenneth Shaw: Regulatory Consultant

If you are planning to visit Advena at Arab Health, please order your visitor pass now to secure your free pass. To register visit this link

Further details about Arab Health 2020 may be found at this link

 

Medical Device Reclassifications or Up-Classifications: Devices that Currently do not Require a CE certificate

There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the EU MDR by 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I under MDD but are Class IIa or higher under MDR) or due to changes in the scope of the legislation (e.g. devices that contain non-viable derivatives of human tissues or cells, which are covered by MDR, but outside the scope of current device directives).

If you have any such devices within your portfolio and need assistance in upgrading your files and submission to your notified body, please do not hesitate to contact us.

Email: info@advenamedical.com

Meet Advena in Miami at FIME 2019

Advena are exhibiting at FIME 2019, this trade fair is considered one of the most important across the Americas and is taking place at the Miami Beach Convention Center in Florida.

Advena will be located at booth B45 in the gold zone, at this important show in Miami from 26th to 28th June 2019.

We will be available to meet existing and prospective clients during this trade show.

Attending on behalf of Advena Ltd., is the Managing Director from our Maltese office, Anthony Kirby. It would be fantastic to connect with any of our clients who plan to visit this important Americas trade show, so please do stop by our booth or contact us for an appointment;

Email: info@advenamedical.com

Further details about FIME 2019 may be found at this link

Meet Advena at Arab Health 2019

Advena will be located in Za’abeel Hall 4, Stand Z4 J43 at this important show in Dubai from 28th to 31st January 2019.

We will be available to meet existing and prospective clients during this trade show.

We advise those who would like to meet one of our team to email for an appointment (info@advenamedical.com) well in advance to ensure we are available.

At this show the following Advena team members will be in attendance:

Anthony Kirby: Managing Director (Advena Malta)

Kirsty Ostle: Managing Director (Advena UK)

Kenneth Shaw: Regulatory Consultant (Advena Malta)

 

If you are planning to visit Advena at Arab Health please order your visitor pass now to secure your free pass and avoid the on-site registration fee. To register visit this link

Further details about Arab Health 2019 may be found at this link

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