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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.

MDR ARTICLE 120(3) TERMS AND CONDITIONS

It would seem like there will be a considerable number of medical devices compliant with the MDD on the market after 26 May 2020. To compensate, the Article 120(3) of the MDR requires that such devices opting for this ‘legacy route’ meet certain conditions:

From 26 May 2020:

  • The device continues to comply with the Directive.
  • There are no significant* changes in the design or intended purpose.

Furthermore, the requirements in the MDR related to the following shall apply:

  • Post-Market Surveillance [Article 83-86, 92, Annex III]
  • Market Surveillance [Article 93-100]
  • [Article 87-92]
  • Registration of economic operators and devices [Article 31 and 29]

* The MDCG have produced guidance on significant changes, please see this link.

Whether a change in design or intended purpose may be considered as significant shall be determined on a case by case basis, however, the following changes shall not be considered to be significant:

  • Reductions or limitations of the intended purpose.
  • Design changes related to corrective actions assessed and accepted by the Competent Authority.

The Notified Body who has issued the AIMDD/MDD certificate shall continue to be responsible for the surveillance relating to the devices it has certified.

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

Medical Device Regulation (MDR) EU Regulation – Class I Reusable Surgical Instruments

Manufacturers of Class I Reusable Surgical Instruments must now obtain a CE certificate under Annex IX Chapters I & III or Annex XI – Part A (limited to the re-usability aspects, as appropriate) by no later than May 26th, 2020 for these devices.

Failure to do so will exclude them from placing these devices on the EU market from May 26th, 2020 onwards or until you achieve CE certification.

To be clear your current medical device registration (MDD) will become invalid on May 25th, 2020. You must act now if you wish to continue to CE mark and supply these devices.

Remember, while Notified Body CE certification is limited to the aspects concerning the reusability of your devices, all your technical documentation must also be upgraded to comply with the MDR and Advena can assist with the technical file upgrades.

Time is now running out and there are only two Notified Bodies currently designated to MDR (BSI UK & TUV SUD). The EU Commission have promised that more will be available by the end of the year, therefore, it makes sense to begin the process of upgrading your technical documentation/files now. So, you need to instruct your regulatory team to begin preparations, if you don’t have the resources internally please do not hesitate to contact us, as mentioned above, we can help!

Email: info@advenamedical.com

BREXIT UPDATE! UK & Non-UK Based Medical Device Manufacturers

As many of you will now know, the Conservative & Unionist Party have elected a new leader in Boris Johnson, who has also become the UK’s new Prime Minister.

The new Prime Minister has clearly laid out his plans for the timetable of Brexit, in as much as that he and his team of cabinet ministers now speak with one voice, that the UK will leave the EU,  on or before the 31st October 2019, either with an improved deal or on a no deal basis.

The EU have stated, that they do not want the UK to leave without a deal but will not renegotiate the deal that has been offered. The UK’s new Prime Minister and his team does not accept the EU’s deal and prefers not to leave without a deal, however, and crucially are prepared to exit the EU without a deal.

This situation makes it increasingly likely that the UK will leave the EU on the 31st October 2019 without a deal.

So, what does this mean for UK medical device manufacturers?

Obviously, the key date to consider is the 31st October 2019, after this date UK based device manufacturers may no-longer be permitted to legally place product on the EU market without appointing an EU Authorised Representative (EC Rep).

If a deal is struck between the EU and the UK the implementation period that has already been agreed allows UK manufacturers until December 2020 to appoint an EC Rep and update your information and materials, including, but not limited to, packaging, product labels, IFU’s, brochures, CE Certificate, and Declarations of Conformity where you can be expected to indicate the name and address of your EC Rep.

However, if the UK crashes out of the EU without a deal on the 31st October 2019 (and this is now the most likely outcome) the implementation period is removed, the EU will not provide a transition period, meaning that UK device manufacturers will almost certainly be locked out of the EU until such time that they have appointed an EC Rep, updated device registrations and their information and materials as mentioned above.

Equally all manufacturers based outside the UK wishing to continue to market within the UK after a no-deal Brexit, must be aware of the new requirement for a dedicated UK Responsible Person (UK RP). The UK RP would be responsible for performing registrations with the MHRA. We provided some guidance back in February and again in March which suggested that Advena Ltd UK will be able to offer this service.

Therefore, October 31st, 2019 will be a critical date!

We strongly recommend both UK based, and non-UK based medical device manufacturers contact Advena to discuss the options available to them. We are uniquely based in the UK and in Malta, where we offer our EU Authorised Representative service from Malta, the UK Responsible Person service from the UK and a full range of medical device regulatory and QMS consultancy services from both offices, therefore a local UK/EU service to help maintain both EU and UK market access. And of course, we are English speaking as is our team in Malta.

With over 20 years’ experience as a provider of regulatory services we have a wealth of knowledge that you can benefit from.

Please contact our team for more details: info@advenamedical.com

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