CE marking
Regulation (EU) 2017/745
The regulation (EU) 2017/745 on medical devices (EU Medical Device Regulation) is the legal framework that medical device manufacturers must comply with in order to place medical devices on the European market. The European Medical Device Regulation (MDR) came into force in 2017 and defines requirements on notified bodies, distributors, importers and healthcare facilities such as hospitals. The EU Medical Device Regulation replaces Directive 93/42/EEC on medical devices (Medical Device Directive/MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD). The MDR came into force on 26 May 2021, but the transitional provisions will continue until 31 December 2028 at the latest. As a Notified Body, mdc is your competent partner for CE certification in accordance with the new Regulation (EU) 2017/745.
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Services for the CE certification of medical devices
On behalf of manufacturers, we perform the necessary certifications as a Notified Body in accordance with Regulation (EU) 2017/745 as part of the conformity assessment of products and quality management systems. Our services include conformity assessment procedures for all manufacturers of almost all active and non-active products, in particular for manufacturers of products of classes IIa, IIb and III, as well as products of classes Ir, Is, Im.
The focus of our activities in this field is both the auditing of the QM system at the manufacturer’s premises and its subcontractors as well as the review of the technical documentation of the products concerned, taking into account the risk class of the devices.
In order to perform these activities, we assign auditors and experts with many years of experience in industry, clinics, testing laboratories and notified bodies.
Classification | Assessment procedures offered by mdc |
---|---|
Products of class Is, Im, Ir | Procedure according to Annex IX, Chapter I & III or Procedure according to Annex XI, Part A |
Products of class IIa | Procedure according to Annex IX, Chapter I & III or Procedure according to Annex XI, Part A |
Products of class IIb, non-implantable or simple implantable devices according to Art. 53 (4, second paragraph) MDR | Procedure according to Annex IX, Chapter I & III |
All other Class IIb implantable devices All class III devices | Procedure according to Annex IX, Chapter I & III together with Procedures according to Annex XI, Chapter II |
Our certification is recognised by our cooperation partners for product authorisation in Ukraine.
Services for third countries
Product authorization in Ukraine
An overview of the product classification
The adoption of Regulation (EU) 2017/745 in the European Parliament resulted in numerous changes for the certification of medical devices. The MDR distinguishes different risk classes I, I*, IIa, IIb and III for medical devices; the classification determines which conformity procedure is required and possible for market authorisation. Apart from the lowest risk class (class I), a notified body must be involved in the conformity assessment of all medical devices – to varying degrees, depending on the patient risk.
As the MDR is directly applicable law as a European regulation and replaces the previous directives (MDD and AIMDD), manufacturers must go through a complete re-assessment of all devices. Such a conformity assessment procedure under the MDR is equivalent to recertification and is mandatory for placing medical devices on the market in Europe.
We offer those interested in certifications the opportunity for an initial exchange of information.
CONTACT OUR MDR TEAM
Procedure of a certification process
The following table gives an example of an mdc certification procedure in the field of medical devices as part of the CE marking required certifications according to Regulation (EU) 2017/745.
MDR Documents
Overview of mdc documents on MDR that may be of interest
01
Preperation
- enquiry by the interested party with a detailed description of the products and their intended use as well as production sites and suppliers
- Preliminary review and offer
- Application including the complete product list
- Contract
02
Assessment
- review of the technical documentation (incl. SSCP if applicable)
- Special procedures
- Inspection of the QM documentation
- On-site audit (2-stage)
- Assessment report
03
Certification
- Evaluation
- Decision
- Issue of the certificate
04
Surveillance
- PReview of the technical documentation (based on sampling)
- Assessment of the periodic safety reports (PSUR)
- Assessment of updates to the SSCP (if applicable)
- Surveillance audits
- Notification and evaluation of changes
- Unannounced audits and product testing
05
Re-Certification
- Preparation
- Assessment
- Certification
Additional services that may be of interest
EN ISO 13485
Here you can find more information about the product EN ISO 13485
Third countries
2017/746 (IVDR)
Here you can find more information about the product 2017/746 (IVDR)
FAQ on MDR
Transitional periods of the MDR
On 7 March 2023, the European Council extended the transitional periods for recertification in the European Medical Device Regulation by Regulation (EU) 2023/607 with the intention to prevent impending bottlenecks in the supply of medical devices. The new deadlines shall relieve the burden on notified bodies and provide time to complete conformity assessment procedures with medical devices in good time.
Depending on the risk classification, various transition periods apply for the implementation of the new regulation.
- 26.05.2026: Class III custom-made devices
- 31.12.2027: High-risk medical devices: Class III medical devices and Class IIb implantable devices (exceptions in accordance with Art. 53 (4, second paragraph) MDR)
- 31.12.2028: Medical devices with medium risk: Class IIa medical devices, all other Class IIb medical devices, Class Is and Im devices, devices that require a certificate from a notified body under MDR and did not require one under MDD
- Special transition periods for devices according to Annex XVI MDR (devices without an intended medical purpose)
In order to benefit from the extended transition periods for MDD or AIMDD certificates, manufacturers must have concluded an MDR certification contract with a Notified Body for the products concerned. A “Confirmation Letter” can be issued by the notified body as proof of the continued validity of the directive certificates.
What does the Medical Devices Regulation regulate?
Regulation (EU) 2017/745 defines the requirements for medical devices to be placed on the European market. As a European regulation, the MDR is directly applicable law and – unlike the previous European directives – does not have to be transposed into national legislation.
The regulations focus on the requirements for market access and therefore on the safety and performance of products throughout their entire life cycle.
The extensive requirements apply to both the authorisation phase (pre-market phase) and the post-market phase (post-market surveillance, vigilance).
During implementation, this means increased legal requirements for manufacturers and other parties involved in the distribution chain as well as users of medical devices. A particular focus of the new regulations is on the validity and quality of clinical data. In addition, the MDR also includes a higher classification of certain products and extended requirements for the content of technical documentation. Monitoring and traceability by means of a unique device identifier (UDI) after the product has been placed on the market is another innovation that follows the international trend.
The previous national register databases shall be replaced by the European database on medical devices (EUDAMED). This includes both the registration of manufacturers and medical devices and the reporting of incidents and corrective actions, registration of device certificates and documentation on clinical trials.
As a notified body in accordance with Regulation (EU) 2017/745 on medical devices, we support you with certification and assist you with your conformity assessment procedure.
What are the advantages of MDR
The MDR is a European regulation and therefore directly applicable law in all EU member states and replaced the previously applicable directives on 26 May 2021. For some products, there are further transitional periods (anchor link to “Transitional periods of the MDR”) (until the end of 2027 or the end of 2028). Once the transition periods have expired, the new regulations are the only applicable regulations in the European Union for placing a product on the market. Only physical products that are already in the distribution chain or have been put into service can still be considered as conform devices.
The aim of the new regulations for patients is to set higher requirements for the evidence of safety and, in particular, clinical performance, so that the individual user or patient can rely on the high quality of the products.
For manufacturers, the MDR has the advantage that it is European law. The aim is a Europe-wide harmonised interpretation of the requirements for medical devices so that the same requirements apply to all manufacturers – regardless of location.
What are the requirements for MDR on manufacturers and their medical devices?
The MDR places comprehensive requirements on manufacturers and stakeholders.
MDR requirements across all products
• Quality management system
• Risk management system
• Person responsible for regulatory compliance
Product-specific requirements of the MDR
• Classification of products
• Basic safety and performance requirements and technical documentation
• Clinical evaluation (with clinical investigation, if applicable)
• Unique Device Identification (UDI)
• Labelling / marking
• Conformity assessment and declaration of conformity
• Post-market surveillance and vigilance
What are the differences between the MDR and the MDD and AIMDD?
The most obvious difference is that Regulation (EU) 2017/745 (MDR) is directly applicable European law, while the Directives 93/42/EEC on Medical Devices (MDD) and 90/385/EEC on Active Implantable Medical Devices (AIMDD) required implementation in national law (e.g. Medical Devices Act / MPG) that showed potential for harmonisation in the past. Once this further legislative step has been removed, the same requirements will apply to devices throughout Europe.
The second obvious difference is the extent. While the Medical Device Directive (MDD) regulates all requirements for medical devices in 23 articles on 25 pages, the MDR comprises 123 articles on 121 pages. It should be noted that none of the requirements of the directives have been deleted, but numerous new aspects have been added.
• Extended scope of application: integration of all products for cleaning, sterilisation or disinfection of other medical devices, reprocessed single-use medical devices and certain non-medical devices
• Reassessment of the risk classification of various products
• Detailed requirements to the QM system for manufacturers
• New labelling obligation: introduction of a system for identifying and tracing devices (Unique Device Certification (UDI))
• Higher requirements for technical documentation (TD)
• Higher requirements for the quality of evidence of clinical performance
• Requirements for the expertise and qualification of the responsible person
• Stricter requirements for Notified Bodies: Requirements for processes, qualification requirements for personnel, and a complex procedure for designation and review
• Introduction of consultation by an independent panel of experts in the clinical evaluation of specific high-risk products
• Safety approach for the entire product life cycle
• Increased transparency and collaboration through data collection on companies, devices and UDIs in the new European Database for Medical Devices (EUDAMED)
• Requirements for the distribution of medical devices via the internet and distance selling
These changes lead to increased effort for manufacturers when implementing the quality management system. This results in increased requirements for the planning, implementation and evaluation of the requirements (Essential Safety and Performance Requirements according to Annex I MDR) as well as for the presentation in the technical documentation.
On the other hand, the increased requirements for the notified bodies lead to increased administrative effort, but also to an increase in the time required for on-site audits and the review of the technical documentation.
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