Devices and Diagnostics

Regulatory strategy services


Regulatory strategy that delivers

For the highest chance of success, a defined, comprehensive regulatory strategy that takes into account both commercial and scientific considerations is vital. Our team of experts will support you in traversing the correct regulatory pathway, allowing you to take the most appropriate route to market while remaining compliant. 

Woodley BioReg consultants provide an almost unrivalled level of knowledge, with extensive practical experience in the sector — meaning that you can be confident we offer only the best advice and guidance.

Device design

Consideration of your regulatory strategy should begin when your nascent device idea is in the very early stages. Our team of medical and In Vitro Device (IVD) experts can review your concept from a regulatory standpoint, offering support and guidance on development to ensure the highest chance of regulatory compliance.

Design History File (DHF)

Each medical device, product or diagnostic developed and manufactured must have a Design History File (DHF). This is a collection of records and documents collated and maintained from the beginning of the development stage, detailing the way a manufacturer has controlled the design and development process, and recording all of the ‘design controls’ undertaken. This is necessary to ensure conformity with regulations.

Woodley BioReg’s MedTech consultants will guide you through the process of creating and maintaining the DHF at the earliest stage, as one of the foundations in achieving expedited compliance.

Classification via EU CE mark, UK CA mark, or FDA 510k/PMA

Conformity assessment with regulations takes a different form depending on the geographical market. There is CE marking in the EU, the new UKCA mark in Great Britain, and 510(k)/PMA in the USA. The various regulations can consider devices slightly differently — and it may not always be clear what category your device will fall into, especially if it is a borderline product.

We can offer advice and guidance on the appropriate classification for your product, ensuring the right regulatory pathway is followed and the correct information and data is collected during the product development stage.

For more information about the CE mark, UKCA mark and 510(k)/PMA certification and their relative classifications, discover more via our resource centre

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Conformity assessment route

A conformity assessment consists of a set of processes that evidence your product meets the requirements of a regulation. To achieve a CE mark in the EU, the conformity assessment route allows the relevant notified body to verify your compliance to the medical device / In Vitro Diagnostic (IVD) regulations. In the EU, conformity assessment procedures can vary depending upon product classification and can often be difficult to understand and navigate, particularly for complex devices.

At Woodley BioReg, we will support you through conformity assessment, ensuring that you have everything you need to comply, and that the process runs as smoothly as possible.

Well-Established Technology (WET)

The new Medical Device Regulation (MDR) in the EU refers to “well-established” technology in Article 52(5). Although not clearly defined, if your product can be identified as WET, it may not require a new clinical investigation and does not require the technical documentation to be assessed. Well-established technology may also be able to confirm conformity through an evaluation of evidence from other sources, such as data from similar devices.

Our team of expert consultants will help to identify if your product qualifies as WET, and if so, what evidence is needed for conformity, particularly with respect to the necessary Clinical Evaluation Report (CER).

Gap analysis — from MDD to MDR, and IVDD to IVDR

Published on 5th May 2017 and having entered into force from 26 May 2017 with a two-year transition period, the new MDR (Regulation (EU) 2017/745 on medical devices) and IVDR (Regulation (EU) 2017/746 on in vitro diagnostic medical devices) are now fully implemented and increasingly more stringent than their predecessors, resulting in manufacturers needing to understand the differences when re-certifying.

At Woodley BioReg, our specialist team can undertake a gap analysis of your technical documentation against the new requirements to ensure future compliance. We will support you through bridging any gaps and carrying out any necessary remediation work. This includes classification reviews to ensure that your product is still registered in the correct class as some can no longer be self-certified, having been upregulated into higher risk classes e.g. mobile applications and Covid-19 antigen tests.

Getting your product lifecycle off to the right start means developing a comprehensive and effective regulatory strategy that delivers on time and to budget. Our consultants are experienced in delivering high quality work on time to ensure that your product has the best possible chance of success.

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