We provide a comprehensive range of quality management services, including support for the set-up and organisation of ISO 13485 quality systems. As specialists in simplifying regulatory compliance for small and medium-sized enterprises, our consultancy services are tailored to your needs at competitive cost-effective rates.
Following the decision for the UK to leave the European Union – referred to as ‘Brexit’ by the media – we are able to assure all clients, existing and new, that Sushvin will continue to cater to medical device consultancy based in the UK.
Medical Device Regulation 2017/745
MDR: 26 May 2021
IVDR: 26 May 2022
The EU Medical Device Regulation (MDR – (EU)2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) were officially published on 5th May 2017 and came into force on 25th May 2017.
Implementation of the MDR and IVDR present a significant challenge for medical device manufacturers. Sushvin’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize and customize Quality and Regulatory solutions which are delivered on time, in budget and with the highest quality. Our highly professional and experienced medical device team is available to provide support as required.
Services Include:
Please contact Sushvin for more information.
Brexit Transition
As the UK has left EU on 1st January 2021, all legal manufacturers are required to register their devices with MHRA as per the given timelines:
| From 1 May 2021 | From 1 September 2021 | From 1 January 2022 |
|---|---|---|
| Active Implantable Medical Devices | Class IIb Non-Implantable Medical Devices | Class I Medical Devices |
| Class III Medical Devices | Class IIa Medical Devices | General IVDs |
| Class IIb Implantable Medical Devices | IVD List B Products | |
| IVD List A Products | Self-Test IVDs |
We have a team of UK responsible person who will be able to assist on behalf of your organisation to register your medical device/IVD with MHRA.
If you need to market your devices, CE mark will no more be valid after 30th June 2023. UKCA and UKNI mark will be required if you plan to market your product in Great Britain and Northern Ireland respectively.
Our team of regulatory professionals will help you reviewing your art work for the Brexit.
Please contact Sushvin for more information.
UK Responsible Person
Are you a legal medical device/IVD outside the UK and would like to market your product in the UK and then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.
As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.
Please contact Sushvin for more information.
PRRC- Person Responsible For Regulatory Compliance
If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746
Please contact Sushvin for more information.
Medical Device Registrations
UK Registration
As per UK MDR 2002, organisations will have to register their product with the MHRA prior to be placed in the UK market.
We have a team of experienced regulatory professionals who can act as UK responsible person on your behalf and get the registrations done.
Global Registration
Our team of experienced regulatory professionals will help you register the product to be placed in different global markets such as USFDA, Canada, Australia, Japan, Brazil, Middle East. Each country has different requirements for placing the product in their market. Our team of regulatory professionals will assist you in getting the documentation ready and placing the device in their respective markets.
MDSAP (Medical Device Single Audit Program)
Registrations through MDSAP is the fastest and the easiest way to place the device into multiple markets with single audit.
Please contact Sushvin for more information.
PMS - Post Market Surveillance/PMCF
As per MDR 2017, chapter VII, legal manufactures are required to conduct post market surveillance on their products for all category of devices.
PMS mainly involves Proactive and Reactive phases.
| Proactive | Reactive |
|---|---|
| Customer Surveys | Customer complaints |
| Post CE Mark Clinical Trials, Including PMCF | Unsolicited User Feedback (Other Than Complaints) |
| Manufacturer Sponsored Device Tracking/Implant Registries | Maintenance/Service Reports |
| Expert User Groups (Focus Groups) | In-House Testing (Routine) |
| Failure Analysis | |
| Social Media | |
| Literature Reviews | |
| Regional or National Device Registries (Non-Manufacturer Sponsored Trials) |
Please contact Sushvin for more information.
Clinical Evaluation Reports (CER)
All legal manufacturers who want to place their device in the EU require a full-fledged clinical evaluation and clinical investigation reports as per MDR 2017/745 Chapter VI. CER mainly involves clinical literature review as per intended use of product along with proving equivalence of the device. We have a team of experienced medical writers who will be able to assist you in clinical evaluation reports.
Please contact Sushvin for more information.
Software As A Medical Device
As per MDR 2017/745 and IVDR 2017/746, software as a medical device requires special attention and registering as a medical device / IVD as per rule 11 of the classification rules of Chapter V MDR 2017/745.
IEC62304: 2016 software as a medical device requires all validation activities, changes to be recorded and documented in the lifecycle of the product.
We have a team of experienced regulatory and quality professionals who will assist your organisation to setup the QMS as per ISO 13485: 2016 and technical file as per MDR 2017/745 and IVDR 2017/746.
Please contact Sushvin for more information.
Combination Drug Device Support
If you are a manufacturer MAH of a pharmaceutical dosage form and as a part of container closure.
Pharmaceutical manufacturers MAH holders who have a medical device as part of their container closure system / dosage delivery require declaration of conformity and notified body opinion letter included in the MAA dossier. We have a team of experienced regulatory professionals who have assisted many pharmaceutical organizations in the registration applications for drug device combination products.
Please contact Sushvin for more information.
