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Regulatory Affairs Consulting

We provide advice, authoring or pre-submission review for regulatory submissions including initial applications, change applications and renewals.

Through experience working at a leading EU Notified Body and UK Assessed Body, we bring insider knowledge of how regulatory submissions are assessed. For our clients, we turn this into actionable insights that save time and money at the assessment stage.

  • We write all types of submission under EU MDR and UK MDR. That includes initial technical documentation submissions, change submissions, and both quality system certificate and technical documentation certificate renewals.

    Our staff have extensive experience assessing these types of applications from working within a leading notified body; they are therefore perfectly placed to write effective submissions.

  • Yes! Not only can we write renewal submissions, we can manage the process and be your point of contact for the notified body, taking pressure off your teams and commercial goals.

OUR PEOPLE

Joseph Langley MEng CEng MTOPRA

Design - Manufacturing - Quality - Regulatory - Management

Underpinned by 7 years at a leading notified body.

DIRECTOR

Bio

The quote that says how we think about this service, in one or two sentences.

Change Submissions

Significant change, or not? We can guide you.

We evaluate whether a modification is a significant change, prepare the change notification, and write the change submission; all informed by experience of working within a leading notified body.

Some submissions are just tricky. Some are huge, with major downstream impacts.

Notified Bodies know that these change projects happen, but they expect information to be presented in a particular way. Our experience brings this to you.

Change projects are numerous and varied, but some examples of change projects we can accelerate include:

  • Design changes

  • Manufacturing process changes

  • Additional manufacturing sites

  • Packaging component or process change

  • Remediation of risk management files

  • Remediation of design control documentation

  • Labelling changes (e.g. EU Rep, CH Rep, Distributor, address changes)

  • Systematic response to audit findings

  • Overhaul of clinical evaluations

  • n the EU regulatory sphere, a “substantial” change is one that typically prompts assessment by the notified body. This could be an on-site audit or a remote technical documentation audit, and may or may not result in re-issue of the certificate.

    Whether a change is “significant” or not relates to the transitional provisions of the MDR or IVDR. Article 120 of MDR (IVDR Article 110 is analogous) states that legacy devices can continue to be placed on the market until the transition period ends “provided there are no significant changes in the design and intended purpose“.

    For interpretation of what is significant, consider MDCG 2020-3 for MDR and MDCG 2022-6 for IVDR.

  • Notified bodies have their own requirements for what to report and how, so check with them.

    In general though, you should submit notifications when you plan to make a change that you have evaluated to be substantial and/or significant, and if you think it is borderline.

  • This depends on factors such as the device classification, the conformity assessment route and the nature of the change.

    The details count here. We can help you with interpretation.

  • Yes. Notified Bodies need information about your suppliers and subcontractors. Whilst this informs a number of audit aspects, it is most critical for NBs to plan unannounced audits, which can be at any subcontractor or supplier - the selection is typically made based on which site will give the best opportunity to witness high risk manufacturing activities.

    Our director, Joseph Langley, previously authored guidance on this topic for BSI.

  • It depends on the classification of the device.

    For lower classification devices, which fall only under an Annex IX Chapter 1 & 3 (QMS) certificate, there is typically more freedom to make changes without prompting assessment. However, it is often advisory to inform. your NB, in case the change does impact the certificate scope.

    For higher classification devices, falling under an Annex IX Chapter 2 (technical documentation assessment) certificate, the NB should be informed any change to indications before implementation, as it is quite likely to require additional assessment.

  • This also depends on device classification, but we would generally advise all examples of a change to a PMCF study protocol should be sent to the NB in advance.

    Clinical requirements are greater than ever in the EU, and particularly for higher classified devices, NBs don’t want to be caught out.

Ready to accelerate your submission?

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