Regulatory Impact of Brexit on Medical Devices

Marking of medical devices in accordance with the requirements of European Council Directive 93/42/EEC as amended permits the sale of CE marked product throughout Europe.

Medimark Scientific Limited are certified by Lloyds Register (LR) in the United Kingdom for the manufacture and distribution of CE marked medical device disinfectants throughout Europe. Such certification is denoted by displaying the CE mark and Lloyds Register’s UK notified body number 0088 on the product label.

The impact of the process known as Brexit on CE marked products manufactured by Medimark Scientific is as yet unclear due to the lack of information and planning that is forthcoming from our Government however, there are a number of potential scenarios that are being considered. Any form of Brexit which does not include plans to allow UK Notified Bodies to continue to provide their clients with CE marking services could directly lead to the risk of patients’ lives in the UK and EU. Our Notified Body believes it is therefore extremely likely that the UK Government and the EU Commission will forge a suitable agreement with the EU27 to prevent this from happening.

Worst Case Scenario – No Deal/Hard Brexit

To maintain our ability to place product on the market in the event of a no deal or hard Brexit, we are required to use a European recognised Notified Body. Our UK Notified body has submitted an application to the Dutch Competent Authority (Inspectie Gezondheidszorg en Jeugd, IGJ) for appointment as a Notified Body in the Netherlands. This will enable them to provide identical services to those they currently provide through their UK Notified Body with what is expected to be a reasonably straightforward process.

If the LR application to the Netherlands is not approved in time and in, what they view as the highly unlikely event of a hard Brexit, then they would be unable to provide Notified Body services for products entering the EU27 markets and as such, current LR issues EC certificates would cease to be valid with effect from the withdrawal date (30 March 2019 00:00 hrs CET). The implications of such a situation are unprecedented.

Therefore, in the worst-case scenario of no deal or a hard Brexit our current EC Certificate will become void on the date at which the UK leaves the EU (29th March 2019). This will result in us not being able to place product on the market until such times as Medimark Scientific Ltd has an EC Certificate from a European Notified Body.

Soft Brexit

In the event that the proposed deal is struck, it is our understanding that a ‘Soft Brexit’ will include an implementation period in which the conformity assessment regime remains unchanged. One possible outcome is that the mutual recognition of Notified Bodies will be included in the proposed transition agreement, covering the period until December 2020 and may also include the possibility of a permanent mutual recognition scheme forming part of the final agreement however, this is yet to be seen. In such a scenario, our existing EC certificate, issued by LR (UK) will continue to be recognised in the EU, in at least the short term, allowing for a period of time to understand what new arrangements are required (if any).

What this could mean for you?

We are continuously liaising with our Notified Body and Government Departments to understand the situation as it unfolds and are putting measures in place to mitigate risks where possible. Existing product that is already in the market, including stock which has been sold to distributors, will continue to be supported under the original CE mark. We feel it necessary to warn customers, particularly those outside of the UK that there may be a period of time whereby Medimark Limited may not be able to directly supply products under our existing CE mark and there may be a delay in obtaining a new CE mark from which is directly linked to the approval of Lloyds Register in the Netherlands and the administration transfer to them. As such we are advising customers to review their current stock levels and order as appropriate in advance of the 30th March 2019 00:00 deadline.

We will endeavor to keep all customers informed of updates as and when they are available. In the meantime, the management team at Medimark Scientific Ltd are on hand to answer any questions that customers may have.

Regulatory Department
19.12.2018

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