Regulatory Consulting for Class I Medical Devices

Effective Class I medical device compliance means fully adhering with all relevant EU MDR obligations while maintaining a streamlined and efficient approach.

Controlled costs and timelines while maintaining complete regulatory alignment
Efficiency over complication
A focused regulatory compliance strategy
No unwarranted embellishments or excess

Finding this balance can be challenging. An experienced team ensures the correct degree of focus, avoiding risks to product availability while protecting budgets and timelines.

A Dedicated Class I Consulting Team

Kamiya Crabtree photograph — Kamiya Crabtree Regulatory Medical Writer

Kamiya leads our Class I service and has overseen submissions across the spectrum. She brings the very best out of professional medical writers and regulatory specialists working as part of each project team. Her approach drives appropriate decision-making during both planning and execution, producing first-rate deliverables.

Although standard Class I devices do not require Notified Body review, our experts will support you every step of the way to commercialisation, including completing the Declaration of Conformity and assisting with device registration with Competent Authorities.

Talk to Kamiya now to meet MDR compliance efficiently

What about exceptions to Class I self-certification rules?

Not all Class I devices are purely self-certification. Class I sterile, Class I measuring, and Class I reusable surgical instrument devices all require limited Notified Body review.

Mantra Systems offers targeted consulting packages with these specific needs in mind, ensuring that Notified Body involvement is forensically prepared for. We also offer an unlimited guarantee of ongoing support in the event of any queries or later issues, and a 100% money-back guarantee of Notified Body Approval.

Contact us today to discuss your requirements with our expert team and ensure expedient, efficient and guaranteed approval for your devices.

Do Class I devices really require full MDR conformity?

Because most Class I devices do not require Notified Body review, it may be tempting to think that expenditure of effort and resources to ensure full conformity with the MDR can be avoided. Afterall, self-certification inherently places the ball in the court of the manufacturer with no direct oversight.

However, lack of alignment with MDR requirements is by far the biggest threat to ongoing market availability of any Class I medical device. Competent Authorities conduct Market Surveillance on an ongoing basis and have the power to remove from the market any devices found not to be in conformity with regulatory requirements. Financial losses in such a case can be devastating, far eclipsing the costs of ensuring alignment in the first place. Furthermore, self-certification requires completion of a Declaration of Conformity – a legal declaration that the manufacturer honestly believes themselves to be in conformity with all relevant requirements. Making a false declaration is a serious offence, with correspondingly serious repercussions.

In summary, ensuring complete alignment from day 1 guarantees safe and uninterrupted market presence of your devices, eliminating unnecessary commercial and regulatory concerns. It also helps build a layer of protection from unregulated ‘me too’ products competing for market share, with legally applied CE-marks being a symbol of product quality and safety recognised around the world.

It’s never too late to ensure full alignment, so contact us today for a free and confidential initial consultation.

What are the further advantages to ensuring full MDR compliance?

Full compliance with the MDR - and legal application of a CE-mark to your devices – offers far more than just a ‘box tick’. A CE-mark is a powerful indicator of device safety and quality, with corresponding recognition not just in Europe but in multiple important global markets.

In the UK, the existence of a separate regulatory framework under the UK MDR (2002) might be perceived as a barrier, although in practical terms the position is more straightforward. Under transitional arrangements, Class I devices certified and CE-marked under EU MDR will be accepted onto the UK market until 30th June 2030. This means that, in the medium term at least, alignment with EU MDR is sufficient to access the UK alongside the European market.

Presence of a CE-mark also opens the door to expedited access to the medical device markets in Australia and Singapore, while Saudi Arabia and India also recognise the mark, alongside other territories.

A further advantage is that a legally applied CE-mark serves as a barrier to copy-cat products looking to enter a market at a lower price point. Legalities aside, given a choice between a legally registered and CE-marked product and a similar product without the mark, the CE-marked product will almost always prevail – especially when the purchaser is an institutional provider.

In summary, investing the resources to obtain secure Class I device registration through full MDR compliance offers long-term commercial security, extensive global expansion opportunities with low barriers, and a degree of protection from lower-priced competitors.

What support is offered for the device registration process?

Mantra Systems offers a full start-to-finish consulting service tailored to the needs of each client. Where requested, this includes ongoing support following completion of the technical file itself. Our team will happily guide you through completion of a Declaration of Conformity and, following this, will support the process of formal device registration in each target territory.

Alongside Class I regulatory consulting, we also offer Market Access services geared towards effective value communication and market positioning, aligning registered products for maximum commercial impact following release.

If you have any questions about our post-registration support, please contact us.

What are my obligations following Class I device registration?

Class I medical devices are subject to the full range of MDR obligations, including those that apply following successful registration of the device. This means that manufacturers need to ensure at least the following systems are in place:

A Quality Management System that ensures that the quality of supplied materials, processes and final products is maintained throughout the device’s lifecycle.
Collection of Vigilance data such as complaints and adverse events through Post-Market Surveillance compliant with MDR Article 83.
Conduct of Post-Market Clinical Follow-Up appropriate to device type, user profile, residual uncertainty and product complexity.
Periodic updates to Clinical Evaluation, Risk Management and other regulatory documents throughout the device’s lifetime.

Do I need an ISO 13485:2016 QMS to register a Class I device?

While operation of a suitable Quality Management System (QMS) is mandatory under MDR, it is not obligatory to conform with ISO 13485:2016. While this ISO standard has become the standard ‘currency’ for medical device Quality Management Systems (and has even been adopted by other industries), there is no requirement to gain ISO 13485 certification to bring a Class I device to market.

Strictly speaking, Class I device manufacturers must meet QMS requirements set out in EU MDR Article 10. In outline, these obligations are:

To cover all parts of a manufacturer’s organisation that deals with the quality of processes, procedures and devices
To set out a strategy for regulatory compliance
To identify applicable GSPRs and a strategy for conformance
To define management responsibilities
To ensure appropriate resource management and control of suppliers and sub-contractors
To conduct appropriate risk management activities
To perform clinical evaluation in line with MDR Article 61 and Annex XIV
To exercise control over product realisation, development and production
To verify UDI assignments and validity of information provided with the device
To set up and operate a PMS system in accordance with Article 83
To establish processes for handling communication with stakeholders
To define processes for reporting and handling of serious incidents
To control management of corrective and preventive actions (CAPAs)
To define processes for monitoring and measurement throughout the device lifecycle

That said, gaining certification to ISO 13485:2016 does offer some advantages. It leads to a presumption of conformity with MDR requirements and has the added advantage of being independently recognised in global territories. It also assists with demonstrating that a manufacturer’s QMS is compliant with MDR Article 10. Ultimately, whether or not to pursue ISO 13485 certification is a decision for the manufacturer. Production of multiple devices arguably strengthens the argument for gaining ISO 13485 certification, whereas manufacturers of a single Class I device may prefer to avoid the additional resource requirements.

For advice on QMS development and implementation, contact our team for a free discussion.

Where can I find more information on Class I device MDR conformity?

The Medical Device Coordination Group (MDCG) produces a wide range of guidelines to support manufacturers and other operators in adhering to the requirements of EU MDR and EU IVDR.

Of particular relevance to Class I devices are the following two guidelines:

MDCG 2019-15 rev. 1 - “Guidance notes for manufacturers of Class I medical devices”. This document provides broad guidance across the major aspects of Class I medical device compliance. Periodically updated, it is a vital source of reference for all Class I medical device manufacturers.
MDCG 2020-2 rev. 1 - “Class I Transitional provisions under Article 120 (3 and 4) (MDR)”. This guideline pertains to transitional arrangements for Class I devices but is perhaps most useful for its summary of requirements when completing a Declaration of Conformity under MDR.

Enquire now to guarantee Class I MDR approval or learn more about our process