Medical Devices Certification for CE Marking

Medical devices play a vital role in the diagnosis, treatment, and care processes of patients. However, it is crucial that these devices are used safely and effectively. Within the European Union (EU), the market placement and use of these devices are regulated by the 93/42/EEC Medical Devices Directive

At Sertifike, we provide guidance and certification services in the medical sector through our extensive collaborative network. Below, you can find some important information regarding the transition from Directive 93/42/EEC to the Medical Devices Regulation (MDR) under Regulation (EU) 2017/745.

The New EU Medical Devices Regulation (MDR)

Regulation (EU) 2017/745, commonly known as the Medical Devices Regulation (MDR), was adopted in April 2017 and entered into force on May 25, 2017. The MDR was developed to replace the previous Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD).

One of the significant changes introduced by the MDR is the expansion of its scope. It covers a broader range of products and technologies, including certain aesthetic devices and products without a medical purpose. The MDR also includes more stringent requirements for clinical evidence and post-market surveillance.

The MDR places a strong emphasis on transparency and traceability of medical devices throughout their lifecycle. Manufacturers are required to provide detailed information about their products to a publicly accessible European database known as EUDAMED. Patients and healthcare professionals can access this database to obtain information about medical devices on the market, including safety and performance data.

Product Classification

The certification process for medical devices can vary depending on the classification of the device. The 93/42/EEC Directive categorizes devices into three classes:

Class I

This category includes low-risk devices such as simple medical devices like thermometers.

Class IIa and IIb

Medium-risk devices fall under Class IIa and IIb. These devices are more complex and may have a greater impact on human health.

Class III

High-risk devices, such as heart pacemakers, belong to Class III. These devices are subject to the most stringent regulations

MDR (Medical Devices Regulation) and Preparation of the Technical File

Significant changes have taken place in the European Union (EU) medical devices sector with the introduction of the new Medical Devices Regulation (MDR – Regulation (EU) 2017/745), replacing the previous Medical Devices Directive (MDD – 93/42/EEC). This new regulation imposes stricter and more detailed requirements for medical devices to be placed on the EU market. One of these requirements is the preparation of the Technical File.

What Is a Technical File?

A Technical File is a document containing detailed information about the design, manufacture, and performance of a medical device. This file is used to demonstrate compliance with the EU MDR requirements for a medical device. The Technical File is prepared by the manufacturer and can be reviewed by EU authorities, notified bodies, and customers. a well-prepared Technical File provides strong evidence regarding the safety and effectiveness of the medical device.

Stages of Technical File Preparation

The process of preparing a Technical File is comprehensive and includes the following steps:

Product Description and Classification

The first step involves providing a clear description of the medical device and correctly classifying it. The device’s class, according to MDR, determines the applicable requirements.

Risk Analysis

The Technical File must identify the potential risks associated with the device. This includes outlining the hazards that may arise during device use and how these hazards are managed.

Design and Performance Data

The Technical File should provide detailed descriptions of the device’s design, specifications, and performance. This includes the device’s intended use and instructions for use.

Quality Management System (QMS) Information

Information about the manufacturer’s Quality Management System (QMS) should be included. This pertains to how production is conducted, monitored, and controlled.

Clinical Data

If the device requires clinical data, it should be included in the Technical File. This section encompasses the results of clinical studies and safety assessments.

Market Surveillance and Recall Plans

The Technical File should also cover market surveillance and recall plans for the device. This ensures continuous monitoring of the device’s safety and effectiveness in the market.

Technical Documents and Test Reports

Technical documents and test reports for the device should be presented within the Technical File as needed.

Preparing an effective Technical File to comply with MDR is a critical step for medical device manufacturers. This file serves as the foundation for demonstrating the safety and effectiveness of the product, allowing it to be placed on the EU market. Manufacturers should manage this process carefully and seek professional support when necessary. Additionally, the Technical File may need to be regularly updated and revised, as both medical devices and regulations can change over time. If you wish to benefit from the expertise of Sertifike experts in all of these stages, feel free to contact us today!

MDR

What is the purpose and scope of MDR?

MDR (REGULATION (EU) 2017/745) is a regulatory framework implemented by the European Union (EU) to ensure the safety, efficacy, and quality of medical devices placed on the EU market. The purpose of the MDR is to modernize and strengthen the regulations governing medical devices, enhancing the protection of public health and patient safety. MDR Regulation replaces the 93/42/EEC Medical Device Directive (MDD) and the 90/385/EEC Active Implantable Medical Device Directive (AIMDD).

Here are some main goals of 2017/745 MDR directive:

  • Stricter Oversight and Surveillance: The regulation enhances the oversight of medical devices throughout their lifecycle, including pre-market and post-market phases. This involves rigorous assessment procedures and continuous monitoring of devices once they are on the market.
  • Transparency and Traceability: The MDR emphasizes greater transparency in the medical device industry. It requires the establishment of a unique device identification (UDI) system to improve the traceability of devices. Information about devices must be publicly accessible via the European database on medical devices (EUDAMED).
  • Improved Clinical Evidence Requirements: Manufacturers must provide more robust clinical evidence to demonstrate the safety and performance of their devices. This includes more rigorous clinical investigations and post-market clinical follow-up.
  • Expanded Scope and Classification Rules: The MDR expands the range of products classified as medical devices and introduces new classification rules to better reflect the risk associated with devices. This includes certain aesthetic devices and products without an intended medical purpose that are similar to medical devices in terms of risk profile.
  • Enhanced Vigilance and Market Surveillance: The MDR strengthens the vigilance and market surveillance systems to ensure rapid detection and management of incidents related to medical devices. This includes the requirement for manufacturers to report serious incidents and field safety corrective actions to competent authorities.

Overall, the MDR aims to ensure that medical devices available in the EU are safe, perform as intended, and provide significant clinical benefits to patients, thereby increasing trust in the medical device sector.

What information should be included in the technical file/documentation? How does the technical file preparation proceed?

According to MDR (EU Regulation 2017/745), the technical dossier is the compilation of documents that must be complied with before medical devices are placed on the market and that verify the safety, performance and quality of the product. Technical documentation should be constantly updated throughout the life cycle of the medical device and revised in accordance with changing/evolving legislation and standards.

What shall be the content of the Technical Documentation of a medical device?

The technical file prepared according to MDR must contain the following information and documents.

  • General Device Description and Specifications:

Intended use, operating principle and detailed product information, model list and differences between models, device materials and critical suppliers, classification of the device and criteria for determining its class.

  • Labeling and Instructions for Use:

Product label and packaging information, user manuals.

  • Design and Production Information:

Detailed descriptions of design and production processes, production schemes, production procedures and instructions.

  • Biocompatibility

Providing evidence that the materials used are biocompatible. Performing tests and evaluating reports.

  • General Safety and Performance Requirements:

Measures taken, performance tests performed and report evaluations to ensure the safety and performance of the device. Risk management file and implemented risk control measures.

  • Benefit-Risk Analysis and Clinical Evaluation:

Evaluation of the benefits and risks of the device, Clinical evaluation report and clinical data.

  • Validation Studies

All production processes (washing, filling, production, packaging, sterilization, etc.)

validation reports and proof documents.

  • Post Marketing Surveillance and Vigilance:

Establishing relevant procedures. Post-market surveillance plan and report (PMS or PSUR), Post-market clinical surveillance plan and report, Trend report. Reporting serious incidents.

Which medical devices fall under the scope of MDR 2017/745?

The first questions that manufacturers ask before putting their products on the market are 'is my device a medical device' and 'how can I determine the class of my medical device?'
The path to follow is explained step by step below.

Let’s start with the definition of a medical device?

Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices:
— devices for the control or support of conception;
— products specifically intended for the cleaning, disinfection or sterilisation of devices.

-MDR Annex XVI products:
1. Contact lenses or other items intended to be introduced into or onto the eye.
2. Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
3. Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
4. Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
5. High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
6. Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.

How is product classification done in MDR?

According to MDR Article 51, devices are divided into I, IIa, IIb and III classes according to their intended use and product risk. Classification is carried out according to MDR Annex VIII. When classifying, attention is paid to the duration of use of the device and the area and tissue the device contacts, and the device is selected as invasive or active.

The first important factor when determining the class of the medical product is the duration of use of the device. There are three different usage periods:

  • Temporary, if intended to be used for less than 60 minutes
  • If it is intended to be used continuously for a short time, between 60 minutes and 30 days.
  • If it is intended for long-term use, continuous use for more than 30 days.

When classifying products, the contact area is taken into account:

  • ‘Body orifice’ means any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
  • ‘Central circulatory system’ means the following blood vessels: arteriae pulmonales, aorta ascendens, arcus aortae, aorta descendens to the bifurcatio aortae, arteriae coronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriae cerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior and vena cava inferior.
  • ‘Central nervous system’ means the brain, meninges and spinal cord
  • ‘Injured skin or mucous membrane’ means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.

Whether the device is invasive or active is checked by:

  • ‘Surgically invasive device’ means: (a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and (b) a device which produces penetration other than through a body orifice.
  • ‘Reusable surgical instrument’ means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out (classified as Ir).
  • ‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
  • ‘Active device intended for diagnosis and monitoring’ means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities.

Product classification rules are given in MDR Annex VIII. In addition, the MDCG 2021-24 Guide includes details on the Classification of Medical Devices.

What is the Unique Device Identification (UDI) system and how is it implemented?

Basic UDI-DI
Defines the device group (devices with the same intended use, risk level and design/manufacturing specifications).
Included in the technical documentation, EC Certificate, Declaration of Conformity and SSCP.
-Not included on the label

Unique Device Identity – UDI
It is defined separately for each device produced. Consists of UDI-DI and UDI-PI.
UDI is placed by the manufacturer on the device or its packaging. Reusable devices have the UDI permanently on the device itself.
Manufacturers are responsible for data entry and updates to the UDI database.

Device model specific identifier – UDI – DI

It is defined specifically for the device model. It is associated with only one Basic UDI-DI.
UDI-DI is stable.

Production unit identifier – UDI – PI
Contains production information. May include serial/lot/batch number, production or expiration dates.
UDI-PI is variable.

UDI allocation organizations:

  • GS1 AISBL
  • Health Industry Business Communications Council (HIBCC)
  • ICCBBA
  • Informationsstelle für Arzneispezialitäten — IFA GmbH

 

What steps should be followed for traceability?

Medical product traceability allows tracking the whereabouts, history and movements of products throughout the supply chain. This is critical to maintain the safety and quality of the products. Here are the steps to follow for medical product traceability:

  • Product identification is made with the UDI system. UDI codes are printed on the devices as barcodes or QR codes and are indicated on all packages.
  • Establishing the ISO 13485 System
    Medical device manufacturers must establish and maintain quality management systems in accordance with ISO 13485 standard.
  • Process control and record keeping
    Controls and records must be kept during production processes. Information such as used raw materials, used equipment, the personnel responsible for the task, date, time, sample amount, which tests were performed, should be documented in detail and should be easily accessible.
  • Supplier and raw material control
    Supplier selection should be made according to the specified criteria and supplier audits should be carried out on a regular basis. Input control shall be done for every raw material or product purchase. For critical raw materials, chemical characterization should be performed on a regular basis.
  • Product recall procedures
    If a product is found to be problematic, recall procedures should be in place so that it can be collected from the market quickly and effectively.
  • Post-Market Surveillance and Vigilance System Establishment
    Manufacturers and healthcare institutions must report any adverse event or device malfunctions that occur during the use of device. These reports are used to continuously monitoring the safety and performance of the device. Based on reported incidents, necessary corrective and preventive actions shall be implemented.

 

What is Post Market Surveillance (PMS)?

A post marketing surveillance system (PMS) is the active and systematic collection, recording and analysis of relevant data on the quality, performance and safety of a device throughout its lifecycle. It is mandatory  to document and keep up to date the PMS procedure, PMS plan and PMS/PSUR report.

How to create a PMS plan?

The post-marketing surveillance plan aims to collect and evaluate the following information:

- information on serious adverse events;

- records referring to non-serious adverse events and data on undesirable side effects;

- information from trend reporting;

- relevant literature, databases and/or records;

- feedback and complaints provided by users, distributors and importers;

- publicly available information about similar medical devices.

What should be considered when creating a PMS plan?

-A proactive and systematic process should be defined to collect the information referred to above.

-Methods, processes, procedures, protocols should be defined to evaluate and analyze the collected data.

-Threshold values ​​and statistical methods should be specified.

- Observation period shall be added for each step.

-Reference to the PMCF plan or a justification if PMCF is not applicable.

Where are the data (outputs) collected with the PMS system used?

- Updating the benefit-risk determination in risk analysis;

- Updating design and manufacturing information, user manuals and labeling;

- Update the clinical assessment;

- Update the safety and clinical performance summary;

- Improve the usability, performance and security of the device;

- Identifying needs for preventive, corrective or field safety corrective actions;

- To detect and report trends.

What is the frequency for updating the PMS and PSUR reports?

The PMS report is prepared for class I products and updated when necessary. The PSUR report is prepared for class IIa and is updated every two years. Prepared PSUR for Class IIb, III and implantable products shall be updated on annual basis.

How shall be PMS and PSUR reports prepared?

Manufacturers of Class I devices shall prepare a post-market surveillance report summarizing the relevant conclusions and assessments of collected data. The justification and explanation of each corrective and preventive action taken should also be evaluated in the PMS report.

Manufacturers of class IIa, class IIb and class III devices; Prepares a periodic security update report (PSUR) as an output of the PMS plan for each device and/or device group.

The periodic safety update report (PSUR) includes:

- The results of the benefit-risk determination;

- Main findings of post-market clinical follow-up;

- Sales volume of the device, size of the population using the device, frequency of use of the device.

The PSUR report should be prepared according to the MDCG 2022-21 Guidelines.

The PMS report should be kept by the manufacturer and shared with the Competent Authorities when necessary.

PSUR reports must be uploaded to the Eudamed database.

How is conformity assessment performed according to MDR? How to get CE Certificate according to MDR?

There are two different ways to obtain the MDR (2017/745) certificate.

  1. If the manufacturer has an MDD (93/42/EEC) certificate, it must apply for MDR and sign a contract for MDR until the MDD certificate expires. Until the MDR certificate is issued, the company must undergo annual inspection according to MDD and meet the requirements specified in Article 120 of MDR.
  2. If the company does not have a valid MDD certificate, it must apply for MDR and wait for the MDR certificate to be issued in order to put its products on the market. In this case, the conformity assessment stages will be as follows.
  1. Application process
    The company must apply to the one of listed Notified Bodies. The application form used by each notified body is different and must be requested from it.
  2. Evaluation

    Based on the submission of the application form, a price offer is submitted and after it is approved by the manufacturer, the technical file is forwarded to the Notified Body.

  3. Technical file review

    The Notified Body carries out technical file review.

  4. Audit is carried out
  5. Closing of non-conformities Non-conformities detected in the audit and technical file review must be closed within a certain period of time and evidence must be submitted to the Notified Body.
  6. Issuance of CE certificate