Prior to CE Marking a medical device in Europe, manufacturers must compile technical and clinical documentation to demonstrate compliance with the EU Medical Device Regulation (MDR) 2017/745.

Further, if the device is not Class I, self-certified, manufacturers must undergo conformity assessment review by a Notified Body. Notified Bodies are accredited and supervised by the European National Competent Authorities , and their role is to evaluate if products have met the minimum safety and efficacy requirements. The Notified Body issues “CE Mark Approval” for the device by issuing a CE certificate.  

The requirements changed as of 26 May 2021, with the implementation of the EU MDR. The previous legislation – the Medical Devices Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC (“the Directives”) included similar, but less robust requirements.

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Technical Documentation File Overview 

All medical devices, irrespective of classification and risk level, require the following elements: 

  1. MDR Annex II – Technical Documentation File (TDF), which includes information related to the product design and manufacturing, product verification and validation, and risk analysis and management
  2. MDR, Annex III – Post-Market Surveillance (PMS) appendix
  3. MDR, Annex XIV – Clinical Evaluation Report (CER), which will also be appended to the TDF

Not all the requirements outlined in Annexes II, III and XIV may apply to your specific device. Manufacturers should determine which sections are appropriate. Where a section is deemed not applicable, manufacturers should document a rationale as to why this has been excluded from the TDF/CER.

Harmonized Standards 

Manufacturers should utilize European harmonized standards and Common Specifications, when available. Doing so presumes compliance with that requirement; further, while use of standards is theoretically voluntary, in practice it is expected that where one exists, it will be utilized. If a standard has not yet been harmonized in Europe for the MDR, then the international version of the standard can be referenced instead.

The list of harmonized standards can be found on the European Commission’s website.

For additional support when drafting a TDF, manufacturers can refer to guidance documents issued by the Medical Device Coordination Group (MDCG). The MDCG:

provides advice to the Commission and assists the Commission and the Member States in ensuring a harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.

Note that while MDCG guidances have taken the place of the former Directive-based MEDDEV guidance documents, some MEDDEVs are still relevant. For example, MEDDEV 2.7/1 rev. 4 related to clinical evaluation can still be referenced as many requirements in this MEDDEV align with the MDR requirements, though there are a few gaps to the MDR which manufacturers must address.

Further, other forms of industry guidance, such as issued by the International Medical Device Regulators Forum (IMDRF), may also be appropriate and help bolster conformity.

The information detailed in the TDF/CER should provide evidence that the General Safety and Performance Requirements (GSPRs), described below, have been sufficiently addressed.

The documentation requirements for Class III devices and implants align with the above but are more comprehensive. The CER generally requires data from a clinical investigation, unless the device type is noted as exempt.

Casus Consulting offers compilation services for both the TDF and CER. We can help you understand how the MDR applies to your device, and thus the required information to be included in each file. We can also provide support in conducting a gap analysis of your MDD/AIMDD files and upgrading them to the MDR.

MDR Key Elements

Basic information regarding the key elements of the EU MDR TDF are further outlined below. Upon reading, you will notice that several of the sections are intertwined. Therefore, manufacturers should consider the technical file as a whole when drafting, rather than looking at the sections as standalone items. For example, the General Safety and Performance Requirements (GSPRs) include information from the Risk Management section, and elements of the Risk Management section need to be considered for the PMS plan.

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Similar to the MDD/AIMDD, the main body of a MDR complaint TDF should include key details and documentation related to the device, including the description, labeling/IFUs, design and manufacturing information, product verification and validation (i.e., data to prove the safety and efficacy of the device).   

Two key components that manufacturers need to develop for the TDF are the General Safety and Performance Requirements and Risk Management section. 

GSPRs – General Safety and Performance Requirements

  • The GSPRs detail the specific criteria manufacturers must meet to establish minimum safety and efficacy requirements for their device, e.g., requirements for performance, risk management, design, etc. 
  • The GSPRs, located in Annex I of the MDR, are similar to the Essential Requirements Checklist (ERC), located in Annex I of the MDD. Manufacturers with MDD CE Marked devices can generally leverage aspects of their ERC to draft the GSPRs. However, there will be several gaps to address.  
  • Current versions of the EU harmonized standards should be noted in the GSPR, where available. If a standard from the MDD applies to a specific product, but the standard has not yet been harmonized under the MDR, manufacturers should reference the MDD version in their GSPRs, when appropriate to do so. 

Risk Analysis & Management  

  • Manufacturers must assess possible risks related to their device and rate the probability of occurrence against the severity of harm if it does occur.  Manufacturers should detail the procedures in place to mitigate the risk or actions to take if it occurs.   An approach some companies follow is to incorporate a Failure Mode and Effects Analysis (FMEA) template as part of their overall risk management system. 
  • EN ISO 14971:2019 is not yet a harmonized standard under the EU MDR. However, it is best practice and manufacturers will generally comply with the MDR if they follow this standard.  
  • Annex I, section 3 of the MDR includes specific criteria that manufacturers must meet when implementing their risk management system. This section states that risk management is “a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating”. 
Post-market Surveillance (PMS) Plan 
  • The Post Market Surveillance (PMS) section of the TDF details the manufacturer’s plan to collect and assess post-market data. The PMS Plan should include information from serious incidents, complaints, public information on other similar medical devices, and more (refer to MDR Annex III, Section 1(a)).
  • The PMS Plan must also establish how the manufacturer will use the data collected to take action when needed. Actions may include making updates to device documentation, such as the CER, improving the risk management and/or taking preventative or corrective action.  
Post-market Clinical Follow-up (PMCF) Plan  
  • The Post-market Clinical Follow-up (PMCF) plan is a subset of your PMS Plan and is very much intertwined with your risk management and clinical evaluation. The PMCF plan is intended to help identify previously unknown risks and to confirm the device’s safety and performance.   
  • A PMCF Plan can include a PMCF study when warranted. However, other methods can also be used to address gaps in your pre-clinical data and to demonstrate a continued positive benefit-risk ratio, when appropriate. Examples include feedback via patient or physician surveys and screening of scientific literature.  
Post-Market Surveillance Report (PMSR) 
  • Manufacturers of Class I devices must prepare a post-market surveillance report (PMSR) based on data collected once the product is on the market. The PMSR is generated through review and analysis of the gathered PMS data and should also include any preventative or corrective actions taken.  
  • The MDR states the PMSR should be updated ‘when necessary’.  
Periodic Safety Update Report (PSUR) 
  • Manufacturers of Class IIa, IIb and III devices are required to prepare a Periodic Safety Update Report (PSUR) for each device.  
  • The PSUR is a living record in which the manufacturer systematically assesses their PMS data to ensure the device continues to be safe and effective and to provide an accurate picture of the products’ performance post-market. This includes any preventative or corrective actions taken and volume of sales.  
  • Manufacturers of Class IIa devices must update the PSUR at least every two years. Manufacturers of Class IIb and III devices must update their PSUR at least annually. Further, manufacturers of implantable or Class III devices must provide the PSUR to their notified bodies and it will be accessible to all national competent authorities and the EU Commission. 

The Clinical Evaluation Report (CER) is a crucial element of the technical file, and includes the following information:  

  • basic device information,  
  • Clinical Evaluation Plan (CEP),  
  • common specifications and harmonized standards,  
  • a clinical literature review,  
  • data from a clinical investigation (if required),  
  • Post-Market Surveillance (PMS) data,  
  • Post-Market Clinical Follow-Up (PMCF) data,   
  • a plan for continual updates to this section, and  
  • other relevant device documentation, such as the IFU. 

Prior to the MDR, and with the issuance of MEDDEV 2.7/1 Rev. 4 (released June 2016), the EU commission began placing more emphasis on the lifecycle approach to the CER. Meaning, it is a living document that should be continually updated. The MDR further supports this approach. Specifically, the MDR states that the “clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan … and the post-market surveillance plan...”.

Note on Clinical Data Exemptions 

Certain devices could be exempt from providing clinical data, per MDR article 61(10). If a device is deemed exempt from providing clinical data, it does not mean the device is exempt from a CER. Manufacturers should detail the rationale for the clinical data exemption in the CER along with an adequate justification as to why article 61(10) applies.  Then, the notified body must accept the rationale.  

A guidance issued by the MDCG (guidance 2020-6) states that Class III and implantable devices are not eligible for the exemption and further, that “in exceptional cases Article 61(10) may be applied for all other device classifications”. 

Additional CER Resources 

In addition to the information located in the MDR, the Medical Device Coordination Group (MDCG) released a number of guidances related to the clinical data requirements, available here on their website. Two that may be particularly helpful to manufacturers are: 

(1) a clinical evaluation report assessment (CEAR) template, which is the document used by notified bodies to assess a CER, and  

(2) a guidance on the post-market clinical follow-up (PMCF) template, which is a key component of the CER.  

There is no publicly available CER template; however, Casus consulting can help you develop a CER tailored to your device.