FAQ

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.

The Medical Device Regulation (MDR) (EU) 2017/745 came into effect on the 25th of May 2017 and operates to replace the following directives:

• Medical Devices Directive (92/42/EEC)
• Active Implantable Medical Devices Directive (90/385/EEC)

As such, manufacturers of medical devices or medical equipment and systems are required by European law to have a Person Responsible for Regulatory Compliance (PRRC) at their disposal at all times. It is the role of this PRRC to ensure all regulatory activities are appropriately undertaken at all times. This PRRC, however, does not need to be the person responsible for actively performing the required regulatory activities.

The full responsibilities of the PRRC, according to Article 15 of the MDR (EU) 2017/745, are as follows:

• To ensure the device conforms to the manufacturer's quality management system before release.
• The technical documentation and EU declaration of conformity are adequately maintained.
• The post-market obligations are complied with.
• The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting.
• In the case of investigation devices, the statement referred to in Section 4.1, Chapter II, of Annexe XV is issued.

A company may employ more than one PRRC, and this is often the case for larger companies where the tasks would be too burdensome for an individual PRRC.

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.

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.

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.

Following the United Kingdom's departure from the European Union, products that would typically display only the European CE mark can now display the UKCA or CE mark if your intended market is in Great Britain.

The UKCA requirements remain broadly similar to the CE mark, including the instances where self-declarations of conformity would be accepted.

Cranage Veritas can assist you with producing and reviewing your technical documentation for your product's declaration of conformity.

The following product types require additional procedures before displaying the UKCA mark:

• Medical devices
• Rail interoperability
• Construction products
• Civil explosives

If you require assistance with your UKCA / UKNI declaration or marking process, get in touch with one of our regulatory specialists to discuss your needs.

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

As detailed on the FDA website (Preparing correct submission), the responsibilities of submitting a 510(k) typically fall to the manufacturer; however, in some cases, this may differ. The following list explains who is responsible:

• Domestic manufacturers (US) are looking to bring a medical device to market in the US.
• Specification developers looking to introduce a medical device to the US markets.
• Re-packers or re-labellers who may alter or change the labelling, or whose operation significantly affects the medical device.
• Foreign manufacturers (Outside of the US), exporters, or US representatives of foreign manufacturers /exporters looking to bring a medical device to market in the US.

An FDA 510(k) is the technical documentation required for those intending to market a medical device in the US, where a premarket approval application (PMA) is not necessary. 510(k)s are predominantly for Class II medical devices (although some Class I and Class III medical devices are also included) that are intended for human use. The 510(k) premarket submission demonstrates a medical device's safety and effectiveness for its intended use. 
 
For those not experienced in submitting an FDA 510(k), the process can be overwhelming, as it requires the submission of lengthy documents, sometimes exceeding 100 pages, which necessitate precise details on your medical device and the relevant safety procedures implemented. In the submission, you will need to detail the similarities and differences of your medical device with a similar device that already exists on the market. The comparable device is known as a predicate device, and it is up to you to demonstrate substantial equivalence. This details the likeness of your device and the predicate device. 
 
Involved in the 510(k) documentation is the detailing of all necessary testing methods and results that have been performed on your product, in line with the predicate device and any additional observed testing requirements. It is essential that you are exhaustive in your testing of the device, as the FDA will require a product to resubmit the 510(k) premarket notification if you do not meet satisfactory detail, or your premarket approval timeframe expands past the 90-day review limit.