Cranage Veritas

To maintain ease of trade imports and exports across the Irish and Northern Irish borders, Northern Ireland will continue to permit the sale of goods displaying the CE mark where there is harmonisation between UK and EU standards.

This means that if your product currently displays the CE mark, it can be permitted for sale in Northern Ireland if no differences in standards or regulations are observed between the CE and UKCA mark requirements.

However, suppose your goods have additional or differing requirements to meet UK standards. In that case, you will need to have testing or certification from either a UK-approved body or a Northern Ireland Notified Body.

For goods requiring CE standards, Cranage Veritas can assist you in certification for the CE mark, as well as assist in compiling your technical documentation and reviewing said documentation.

For smaller companies, employing an individual responsible for regulatory compliance may be unviable, as the costs can be too high an expense.

There is an allowance for this; if you are classed as a micro or small manufacturer (detailed as having fewer than 50 employees and annual turnover does not exceed €10m), then you may subcontract this role to an external party.

Our experience working alongside clients in the medical electrical equipment industry gives Cranage Veritas the appropriate authority to act as a PRRC on behalf of your company.

If you require this service or wish to discuss the MDR (EU) 2017/745 with an expert advisor, get in touch with us today.

Suppose you, as the manufacturer, have the facilities to perform the necessary conformity assessments of your products, and you do not require assistance from a Notified Body. In that case, you will not incur any fees for the declaration of your products’ conformity to EU requirements.

For those who cannot perform the relevant assessments, the inclusion of a Notified Body is required, for which costs can vary depending on the nature of the product and the conformity assessment needed.

Cranage Veritas is an EU Notified Body and can provide you with a Notified Body Opinion regarding your product’s conformity to EU requirements.

The Conformitè Europëenne (CE) Mark – Declaration of Conformity

Obtaining a CE mark enables products to be sold in countries that are part of the European Economic Area (EEA) and those covered by the Mutual Recognition Agreement (MRA). CE marking is the responsibility of the manufacturer and is typically achieved through self-declaration.

A CE mark is not needed for every product entering the European market. Instead, a CE mark is only a necessary legal requirement for specified products (see: products required to display the CE mark).

What is the CE Mark procedure?

By placing the CE Mark on your products, you, as the manufacturer, are declaring your products’ conformity to any relevant EU requirements for that product category.

Before placing the CE mark on your product, you must ensure:

• Your product conforms to all relevant EU-wide requirements
• Determine whether you can self-declare the conformity or if you need assistance from a Notified Body Opinion
• You have complied with the appropriate technical documentation.
• Draft and sign the EU declaration of conformity for your product.

We understand the importance of your medical device to you and to those it helps, which is why we strive to get your product to market as efficiently as possible. Our experts possess all the knowledge, skills, and experience to help make your medical device 510(k) submission as transparent and efficient as possible, thereby reducing the potential for revisions and minimising the total time and costs involved.

We have experience assisting clients in:

• Classification of your medical device or equipment
• Identifying a predicate device
• Identifying the relevant testing procedures required for your medical device or equipment
• Assistance in compiling your technical documentation
• Technical documentation review

According to the FDA, the contents of your 510(k) submission should be presented in “an organised, tabulated document” and should contain:

• Logical presentation of the data
• Scientific soundness of the test and data analysis
• Relevance of the test programme to the device and intended use
• Completeness of the summary report of the test or studies