EU and UK Regulatory Services and Support
Our leadership and staff are BSI-trained, guaranteeing you receive comprehensive support complying with the latest European and UK Medical Device Regulations legislation.
MedTec Consulting is an innovative company; as part of our ISO 13485 Quality Management System, we use a Continuous Improvement process to help us assess unmet need and provide solutions. We have partnered with Compliant Medical Devices Ltd to expand our Regulatory capabilities for all your EU MDR, UK MDR, UKCA, and UK Responsible Person needs.
Total Market Access Project Management
Our team will work closely with you to ensure we understand your technology, processes and ambition.
We will guide you and help develop everything from your launch strategy, NICE application, bespoke Business Cases, product sales and promotion, and everything in between - all the way to using our contact network to develop Key Opinion Leaders.
Commercialisation, Sales and Training
We understand the investment of time, money and resource you have in your product.
MedTec Consulting’s professionals will expedite the Commercialisation process. Navigating you through the often complex maze of reimbursement considerations, and delivering your technology to market using experts with UK, European and international medical training experience.
CE and UKCA Marks
UKCA (UK Conformity Assessed) marking is a UK requirement for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products for sale there require CE marking.
Manufacturers of medical devices can use either UKCA marking or CE marking on devices they place on the GB market until 30 June 2024. From 1 July 2024, UKCA marking will be required in order to place a device on the Great Britain market.
MedTec Consulting has supported medical device manufacturers through third party conformity assessments, and EU Notified Bodies through the process to their becoming UK Approved Bodies. Reach out today if you’d like to engage MedTec Consulting Ltd for your EU and UK conformity needs.
UK Responsible Person
The United Kingdom Medical Device Regulations (UK MDR 2002) requires non-UK based manufacturers of medical devices and in vitro diagnostics to appoint a UK Responsible person in order to place their products on the UK market. This legislation came into force on 1 January 2021.
MedTec Consulting Ltd currently provides UK Responsible Person services for a number of manufacturers, and offers competitive pricing with discounts for multi-product contracts. Please contact us with your UKRP requirements to see how we can help you.
Medical Device Registration
All medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market.
As UKRP, MedTec Consulting has successfuly registered over a thousand devices with the MHRA for our clients. If you would like to discuss how we can assist you in quickly turning around your medical device registrations, please get in touch.
Commercialise Your Product
MedTec Consulting Limited delivers an integrated commercialisation experience; by engaging us, our team will provide streamlined business processes, effective medical device market access strategies, and ensure your company builds an enhanced reputation in the industry through our well-respected contacts.
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Proven track record
Dawn Smiles is the founder of MedTec; she qualified as a Biomedical Scientist and worked in the sector for several years, before progressing to medical sales and commercialisation. Here she enjoyed many successful years and won several international sales awards. Focusing her energies into a streamlined, responsive consultancy allowed Dawn to deliver her trademark high-calibre service to clients, without any constraints.
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We have successfully commercialised innovative medical device products across different sectors of the NHS and Private healthcare. We have also led start-up companies through their journey to acquisition by major international corporations.
We operate across all sectors – from ophthalmology to vascular, and everywhere in between.
Business Services
In addition to our Regulatory Services, we offer multiple solutions for your product – wherever it is in its lifecycle. From Market Access, Gap Analysis, Commercialisation, Sales and Training, all the way through to Business Development; our team will work closely with you to ensure we understand your technology, processes and ambition.
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Reimbursement
We will guide you and help develop everything from your launch strategy, NICE application, bespoke Business Cases, Budget Impact Models, product sales and promotion, and everything in between. We understand the investment of time, money and resource you have in your product.
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MedTec’s professionals will help you navigate through the often-complex maze of regulatory requirements, reimbursement considerations, product pathways – delivering your technology to market using key opinion leaders and experts with UK, European and international medical experience.
Our Team and Contacts
We are proud to have worked with some of the most forward-thinking and innovative medical device companies in the world. From Californian start-ups, to European corporations whose history stretches back over 150 years, MedTec Consulting has been trusted to deliver new technology into the UK market since 2011.
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Flexible approach
The people-focussed approach utilised by MedTec – maintaining a small team while nurturing relationships with influential experts across NICE, the NHS, and Private healthcare – has been welcomed by medical device companies around the world, across a number of disciplines.
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We have a group of handpicked professionals with diverse strengths across a broad range of UK healthcare arenas. The core team remains agile, with enough capacity to react quickly in support of our clients’ needs.
Whatever challenges you face, rest assured MedTec Consulting will support and guide you to a successful outcome.