Conformity assessment according to MDR: Your path to CE labelling
Secure EU market access with our conformity assessments
The Medical Device Regulation (MDR) defines strict requirements for the conformity assessment of medical devices in the EU. Our experts will guide you through the entire process and support your market access with structured assessment procedures - reliably, efficiently and in compliance with standards.
What is the EU Medical Device Regulation (MDR)?
The Medical Device Regulation (MDR, Regulation (EU) 2017/745) has been fully in force since May 2021 and replaces the previous Medical Device Directive 93/42/EEC (MDD). As an EU regulation, it applies directly in all member states and places increased requirements on the safety, performance and traceability of medical devices. The MDR defines comprehensive regulations for the manufacture, distribution and monitoring of medical devices with the aim of improving patient protection.
The MDR brings significant tightening and extensions:
- Stricter classification rules for medical devices
- Extended requirements for clinical evaluations
- Introduction of the Unique Device Identification (UDI)
- More comprehensive post-market surveillance
- Extension of the scope of application to devices without a medical purpose
- Increased transparency through EUDAMED database
What does conformity assessment mean in the context of the MDR?
Conformity assessment is a structured procedure that checks whether a medical device fulfils the essential safety and performance requirements of the MDR. Depending on the risk class of the product, different procedures are prescribed, ranging from self-certification (only for Class I) to comprehensive inspections by notified bodies. The result of a successful conformity assessment is the CE marking, which enables market access in the European Economic Area.
The MDR categorises medical devices into four risk classes:
- Class I: Low risk (e.g. wheelchairs, dressing material)
- Class IIa: Medium risk (e.g. dental fillings, hearing aids)
- Class IIb: Increased risk (e.g. ventilators, X-ray equipment)
- Class III: High risk (e.g. heart valves, implants)
The higher the risk class, the more intensive and earlier in the life cycle the monitoring of products and organisations by the notified body and the authorities.
How does the conformity assessment process work at the Notified Body?
As a Notified Body, we carry out the conformity assessment process according to a clearly structured procedure:
The process begins with your enquiry. We check the basic feasibility and prepare a customised offer based on the specific requirements of your medical device and the corresponding risk class.
After accepting the offer, you submit a formal application for conformity assessment. We check the completeness of the documents and the admissibility of the application according to our designation and your product portfolio.
Our technical experts assess your technical documentation for compliance with the essential safety and performance requirements of the MDR. Particular attention is paid to the review of clinical evaluation, risk management and biocompatibility.
We carry out a comprehensive audit of your quality management system, which is ideally already certified in accordance with ISO 13485. We evaluate the implementation and effectiveness of all quality-relevant processes that are required for the manufacture of the medical device.
Identified deviations or defects are clearly documented and communicated. You are given the opportunity to implement and demonstrate corrective measures. We check and evaluate the effectiveness of these measures.
Once all aspects have been successfully assessed, the notified body makes the certification decision. If the result is positive, the EU certificate of conformity is issued, allowing you to affix the CE marking and sell your product on the European market.
Initial certification is followed by regular surveillance audits and inspections to ensure that conformity is continuously maintained.
How are EN ISO 13485 and MDR linked?
EN ISO 13485 and the MDR are closely related, but complement each other in terms of their requirements and objectives.
- EN ISO 13485: Defines the requirements for the quality management system for medical devices
- MDR: Defines legal requirements for EU market access
EN ISO 13485 certification is not a legal requirement for MDR conformity, but it does represent the recognised state of the art for fulfilling the QM requirements of the MDR. A quality management system certified in accordance with EN ISO 13485 already fulfils many of the organisational and procedural elements required by the MDR
The MDR provides the specific design of the regulatory requirements for the European Economic Area, which are kept open in EN ISO 13485.
In some areas, the MDR goes beyond the requirements of ISO 13485:
- More specific requirements for clinical evaluation
- More detailed regulations on post-market surveillance
- More comprehensive transparency requirements (EUDAMED)
- Stricter regulations for economic operators
What advantages does the MDR conformity assessment offer?
- Market access: Legal access to the European market with over 500 million potential users for your medical devices.
- Legal certainty: Proof of compliance with all legal requirements and thus minimisation of liability risks.
- Competitive advantage: Differentiation through proven safety and performance in a highly regulated market.
- Trust: Strengthening the trust of patients, users and healthcare facilities in your products.
- Global recognition: MDR conformity is increasingly recognised as a quality standard outside the EU.
What challenges does the MDR conformity assessment present?
The changeover to the MDR poses considerable challenges for many manufacturers:
- More extensive technical documentation
- Higher requirements for clinical data
- More stringent proof of biocompatibility and chemical characterisation
- Implementation of extended vigilance and aftermarket systems
- Adaptation of supply chain control
- Implementation of UDI requirements
- Increased time and costs for conformity assessment
- Need for specialised experts
- Longer lead times for market launch
Our services for MDR Conformity Assessment
As a Notified Body, we offer you comprehensive services as part of our conformity assessment according to MDR:
- Review of technical documentation for all risk classes
- QM-System-Audits according to the requirements of the MDR
- Product testing and type testing in accordance with the specific annexes of the MDR
- Review of clinical evaluations and clinical evidence
- Regular review of your post-market surveillance measures
- Assessment of change notifications for product modifications
- Support with post-market surveillance
- Information on regulatory developments (without limiting our neutrality as a Notified Body)
Berlin Cert GmbH offers certifications according to EU Regulation 2017/745 (MDR) for Annexes IX, X, XI(A), XI(B) for medical devices of classes Ir, Im, IIa, IIb and III in the following scopes:
- Active non-implantable devices for imaging, monitoring and/or diagnosis
MDA 0202: Active non-implantable devices for imaging procedures with non-ionising radiation
MDA 0203: Active non-implantable devices for monitoring vital physiological parameters
MDA 0204: Other active non-implantable devices for monitoring and/or diagnosis - Active non-implantable therapeutic devices and general active non-implantable devices
MDA 0302: Active non-implantable devices with non-ionising radiation
MDA 0305: Active non-implantable products for stimulation or inhibition
MDA 0306: Active non-implantable devices for extracorporeal circuits, for the administration or removal of substances and for haemopheresis (Restriction: Excluding active devices intended to deliver to and/or remove from the body medicinal products, body fluids or other substances where this procedure presents a potential hazard taking into account the nature of the substances concerned, the part of the body concerned and the method of application (Rule 12 Annex VIII Regulation (EU) 2017/745))
MDA 0307: Active non-implantable ventilators
MDA 0309: Active non-implantable ophthalmological devices
MDA 0310: Active non-implantable devices for the ear, nose and throat
MDA 0311: Active non-implantable dental devices
MDA 0312: Other active non-implantable products for surgery
MDA 0313: Active non-implantable prostheses, rehabilitation products and patient positioning and transport products
MDA 0315: Software
MDA 0316: Medical gas supply systems and their parts
MDA 0317: Active non-implantable products for cleaning, disinfection and sterilisation (restriction: cleaning and disinfection only)
MDA 0318: Other active non-implantable products
- Non-active non-implantable products
MDN 1205: Non-active non-implantable devices for orthopaedics and rehabilitation
MDN 1207: Non-active non-implantable diagnostic devices
MDN 1208: Non-active non-implantable instruments
MDN 1214: General non-active non-implantable devices used in healthcare and other non-active non-implantable devices
MDR conformity assessment with Berlin Cert
As a Notified Body, we are characterised by the following features:
- Expertise: Our auditors have many years of experience in the medical device sector
- Efficiency: Structured processes for rapid assessment procedures
- Transparency: Clear communication and comprehensible decisions
- Neutrality: Consistent compliance with the prohibition of consulting by Notified Bodies / Certification Bodies