What is a certificate with conditions?

According to Annex VII of MDR (and by analogy IVDR), notified bodies may issue a certificate on the condition that additional requirements are met—such as restricted indications for use, a defined target patient population, or the obligation to provide Post-Market Clinical Follow-up (PMCF) data. Certificates may also be granted for a reduced validity period or require periodic reporting.

When is conditional certification appropriate?

Conditional certificates are particularly relevant for devices that are: innovative or considered breakthrough technologies, addressing unmet clinical needs, subject to limited clinical evidence at the conformity assessment stage, requiring rapid market access under enhanced post-market surveillance.

Examples of possible conditions

Certificates may include provisions such as: submission of PMCF data every 6 months, exclusion of certain populations (e.g., paediatrics), restricted use to designated healthcare institutions, mandatory inclusion in a clinical or user registry, shorter certificate validity (e.g., 3 years).

Team-NB position and CORE-MD reference

The Team-NB paper references the CORE-MD D3.3 report, which highlighted the limited use of conditional certificates under the previous Directives and called for greater adoption under MDR. The association encourages notified bodies to apply this pathway under section 4.8 of Annex VII. It also cites the European Commission’s endorsement expressed in MDCG 2024-10 concerning orphan devices.

Certificates with conditions offer a way to balance patient safety with timely access to innovation. By enabling controlled market entry, this approach supports the availability of novel devices while maintaining regulatory rigour. It represents an opportunity for manufacturers, patients, and healthcare systems across Europe. Team-NB Statement – Certifications with Conditions

Check information about EU Medical market ⚕️ MDR Regulator

March 20, 2025

Certificates with Conditions – Team-NB proposal under MDR and IVDR

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) provide the possibility to issue certificates with conditions, limitations, or restrictions. This regulatory flexibility can facilitate market access for innovative and breakthrough medical technologies that may not yet have a complete clinical evidence base. Team-NB, the European Association of Notified Bodies, has published a position paper promoting the wider use of this tool.

February 27, 2025

MDR Regulator at MedTech Summit in Budapest!

Last week, for the second consecutive year, we participated in the MedTech Summit in Budapest – one of the key industry events dedicated to medical device regulations. Our CEO, Katarzyna Wesołowska, shared her expert insights during the discussion panel “Consultants' Experiences in Transitioning from MDR to IVDR.”

February 24, 2025

Registration of Specific Medical Devices in the United Kingdom

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the registration requirements for Class I medical devices and those with expired CE certificates. The new regulations aim to improve oversight of medical device safety and compliance with UK regulations.

February 22, 2025

New Version of MDCG 2019-6 Rev.5 Document on Notified Body Requirements

The Medical Device Coordination Group (MDCG) has published a new version of the MDCG 2019-6 Rev.5 document, which includes updates on the organization, operation, and obligations of notified bodies in the conformity assessment process.

January 30, 2025

MHRA: IMDRF’s Latest Guidance on AI and Medical Device Software

On January, 2024, the IMDRF published guidance on Good Machine Learning Practice (GMLP) for Medical Devices and considerations for medical device software & software-specific risk. These documents provide a framework for ensuring best practices in AI-based medical devices and systematic risk assessment for medical software.

January 17, 2025

MHRA Guidance on New Medical Devices: Post-Market Surveillance Requirements

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices. These new regulations are critical for manufacturers, distributors, and healthcare professionals to ensure the continued safety and effectiveness of medical devices in the UK.

December 27, 2024

A year of breakthroughs in medical devices and in vitro diagnostics: Summary of 2024 year

The year 2024 has been a time of intensive changes and challenges for the medical device and in vitro diagnostics (IVD) industries. As active participants in these sectors, we had the opportunity to witness and contribute to key events that shaped the future of the market and regulatory standards.

December 19, 2024

MDR Certification Process for Medical Devices: Key Insights from the Team-NB Consensus Document

The certification of medical devices under MDR is a multi-step process requiring thorough preparation and collaboration with Notified Bodies. Explore the key stages outlined in the Team-NB consensus document to streamline your certification journey.

November 27, 2024

MDR Regulator at Warsaw Medical Expo

The Warsaw Medical Expo has come to an end, marking another successful event for MDR Regulator. Our presence at the trade fair provided an opportunity to showcase our expertise in regulatory consulting, clinical trials, and market commercialization on a global scale.