Medical devices · Regulatory compliance · Market access
MDRC helps manufacturers define the right regulatory route, build compliant evidence and documentation, secure approvals and maintain access to international markets.
Services
Each service is designed as part of the same product lifecycle, so strategy, evidence, documentation, quality and post-market activities remain aligned.
EU representation for eligible manufacturers established outside the European Union.
Explore EC REP services 02External Person Responsible for Regulatory Compliance support under the MDR and IVDR.
Explore PRRC services 03Creation, restructuring and gap assessment of device and IVD technical documentation.
Explore technical documentation 04Classification and pathway analysis based on intended purpose, technology and risk.
Explore device classification 05Clinical evidence planning, evaluation, literature assessment and lifecycle updates.
Explore clinical evaluation 06Regulatory and scientific support for medical device clinical investigation programmes.
Explore clinical investigations 07Connected risk, vigilance, PMS and post-market clinical follow-up systems.
Explore post-market support 08Submission preparation, deficiency-response support and regulatory liaison.
Explore authority liaison 09Medical device quality systems aligned with the applicable regulatory framework.
Explore quality systems 10Support with market representation and compliant distribution structures.
Explore market representationRegulatory lifecycle
The same intended purpose and risk logic should flow through classification, evidence, documentation, submissions, quality controls and post-market data.
Devices and technologies
We adapt the evidence and compliance system to the device technology, intended purpose, users, clinical context and market.
General, active and non-active medical devices across risk classes.
Implantable technologies requiring integrated risk, clinical and lifecycle evidence.
IVDs supported through classification, performance evidence and technical documentation.
Regulatory support for gene, cell and tissue-based medicinal products.
Software and connected technologies assessed as products with lifecycle evidence.
Product qualification and regulatory planning for disinfecting and sanitizing products.
Markets
A strong core dossier should remain consistent while each market pathway addresses its own classification, evidence, representation, submission and post-market requirements.
EU regulatory roles
Authorized Representative and PRRC are distinct regulatory functions. MDRC helps manufacturers establish the role that applies to their organization and products.
EC REP
A non-EU manufacturer placing a device on the Union market generally needs a duly designated Authorized Representative established in the European Union, subject to the applicable MDR or IVDR provisions.
Explore EU Authorized Representative servicesPRRC
The MDR and IVDR require manufacturers and Authorized Representatives to have access to appropriately qualified regulatory compliance expertise under the conditions defined by the regulations.
Explore PRRC servicesInsights and resources
Use MDRC guidance to understand recurring medical-device compliance concepts, then speak with us about the requirements for your particular product.
About MDRC
MDRC is a medical-device regulatory consultancy supporting manufacturers across product development, conformity assessment, regulatory submissions and post-market compliance.
Our work connects regulatory reasoning with technical, clinical and quality evidence. The result is a clearer pathway, a more coherent dossier and decisions that remain traceable throughout the product lifecycle.
Frequently asked questions
MDRC provides regulatory strategy, classification, technical documentation, clinical evaluation, clinical investigation support, risk management, post-market surveillance, quality-system support, regulatory authority liaison, EU Authorized Representative and PRRC services.
We support general and implantable medical devices, in vitro diagnostic medical devices, medical software, advanced therapy products, disinfectants and sanitizers.
MDRC supports market-access projects in the European Union, the United States, Latin America, Russia and the Eurasian Economic Union.
MDRC provides EU Authorized Representative services for eligible non-EU manufacturers and outsourced PRRC services according to the applicable MDR and IVDR requirements.
Contact MDRC
Describe the product, its development stage and the regulatory question you need to resolve. We will identify the most useful next step.
Cyprus
Souliou str. 1, Strovolos
2018 Nicosia