Meeting the Requirements of the EU’s Medical Device Regulation (MDR 2017/745)

Pre-application and application process:

• Pre-application form, review process outcomes, and implications
• Application form, review process, outcomes, and implications
• QMS, Technical documentation, and Clinical Self-assessment forms
• Service model and options
• Costs, fees, and other financial aspects

Obligations for the manufacturer:

• TÜV SÜD Testing and Certification Regulations 
• Framework Agreement
• Sites, suppliers, devices, and other aspects
• Device classification and MDR code assignment 
• Explanation of Device - novelty – intended purpose – benefit risk criteria, Clinical data generated
• Vigilance reporting
• Handling of device and other changes
• Recertification
• Transfer from/to another notified body

Conformity Assessment Procedure

• General information on the conformity assessment procedures
• Submission requirements
• Planning of the assessment
• Sampling requirements
• Project planning, time limits, and special procedures such as consultation with competent authorities
• Common specifications, guidance documents, position papers, and harmonized standards
• Regulations and standards relevant to the product, technologies, critical materials, and further relevant aspects

Existing clients with TÜV SÜD Notified Body

• If you are an existing client, please get in touch with your dedicated client manager to move forward

Potential clients:

• If you wish to engage TÜV SÜD as a Notified Body and kickstart the Structured Dialogue process, please fill up the following request form: MDR

The MDR applies to an expanded range of medical devices including products that were not previously covered by the MDD and AIMDD. Specific examples of newly covered medical devices include those that do have not a medical intended purpose, such as coloured contact lenses and cosmetic implant devices and materials. Also included in the scope of the MDR are devices designed for the purpose of “prediction and prognosis” of a disease or other health condition.

Device manufacturers are required to identify at least one person within their organisation who is ultimately responsible for all aspects of compliance with the requirements of the MDR. The organisation must document the specific qualifications of this individual relative to the required tasks. Special relief for some of these provisions may be applicable to small enterprises and start-up entities.

Annex VIII of the MDR details the requirements governing the classification of medical devices. In several instances, the MDR classification requirements are more rigorous than those in the MDD or AIMDD, resulting in the assignment of a higher risk class for some devices and the need to meet more stringent requirements than in the past.

Device manufacturers are always required to provide sufficient clinical evidence to support safety, performance and – in addition as a new requirement – the benefit of a medical device – no matter which risk class the medical device is in. Clinical investigations are still mandatory, if no sufficient clinical data from other sources are available – this is also not depending on the risk class of the medical device (MDR Art 61). For all devices, the manufacturer shall have a clinical evaluation plan as described in MDR Annex XIV Part A, where the manufacturer shall provide expected outcome parameters for safety, performance, and benefit. 

Certain devices, such as implantable devices and class III devices have their own MDR rules concerning the necessity of a clinical investigation (MDR Art 61.4). The widely used equivalence approach became more rigorous for these class III and implantable devices (MDR, Annex XIV Part A) due to a required contractual agreement between the manufacturer of the device under assessment and the manufacturer of the equivalent device to ensure access to the technical documentation (MDR, Art 61.5). For implantable devices and for class III devices the manufacturer must annually provide a publicly available document that contains detailed clinical data on safety, performance and benefit of the medical device – the so-called Summary of Safety and Clinical Performance (SSCP) - that is not only understandable for professional users of the medical device – but also understandable for the patient, if applicable. This document will be publicly available on the EUDAMED database. The SSCP is one part of the dedicated post market surveillance process that a Manufacturers must comply with (MDR Art. 32). The post market surveillance process specifically to clinical data is governed in detail in MDR Annex XIV Part B under Post Market Clinical Follow Up. 

For implantable class III devices and class IIb devices according to Rule 12, a new consultation process has been initiated: The Clinical Evaluation Consultation Procedure (CECP). An independent Expert Committee from the EU Commission will review the clinical evaluation assessment report of the Notified Body and will provide an additional scientific opinion on the result of the clinical data assessment (MDR Art 54).

Manufacturers are still required to carefully consider the MDR’s requirements on the use of evidence of equivalence in determining whether or not a clinical investigation is required.

The MDR mandates the use of unique device identification (UDI) mechanisms with medical devices. This requirement is intended to support the ability of manufacturers and authorities to trace specific devices through the supply chain, and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk. In addition, the European Databank on Medical Devices (Eudamed) has been expanded to provide more efficient access to information on approved medical devices.

Notified Bodies now need to be involved in the conformity assessment of class I reusable surgical instruments towards the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use or the reprocessing.

The MDR mandates increased post-market surveillance (PMS) authority by the Notified Body. Unannounced audits, along with product sample checks and product testing will strengthen the EU’s enforcement regime and help to reduce risks from unsafe devices. Annual safety and performance reporting by device manufacturers is also required in many cases.