The introduction of the EU Medical Device Regulation 2017/745 (MDR) and EU IVD Regulation 2017/746 (IVDR) has led to a wave of change in the way these products are regulated in the EU, putting further strain on manufacturers wishing to CE mark their products. The added complexity of these regulations has had a major toll on certain manufacturers with limited resources available to implement new systems and meet their regulatory obligations. Apart from this, most organisations have found it difficult to identify what they must do to their existing documentation to make these compliant.
As a first step, we always recommend that manufacturers conduct a detailed Gap Assessment against any new set of regulations (or standards, guidance, etc.). This enables the company to put together a regulatory strategy to meet its obligations and maintain compliance.
Our in-depth and detailed Gap Assessment service involves our team delving deep into your existing technical documentation and highlighting any gaps when compared to the following:
- EU MDR 2017/745.
- EU IVDR 2017/746.
- UK MDR 2002.
- EU Harmonised Standards.
- MEDDEV / MDCG Guidance.
The Specculo team will then put together a detailed Gap Assessment Report which quotes the requirement, states the finding, and provides suggestions on how to close the gap. We also provide pointers for the improvement of your technical documentation based on best practice and Notified Body experience.
Following the Gap Assessment process, we can schedule a call to discuss the findings and build a regulatory strategy to close any deficiencies and improve the technical documentation further.
Following an initial consultation, a member of the Specculo team will get in touch to request that you share your existing technical documentation and any other relevant information. Our consultants will then build the Gap Assessment Report and may schedule a meeting to discuss the gaps highlighted during the project. We can then work together to build a Regulatory Strategy and close out the identified findings and improve the technical documentation further based on best practice and experience with Notified Body reviews.
What you get with Specculo
We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.