FOR MEDICAL DEVICE START-UPS: A BRIEF GUIDE TO CE MARK CERTIFICATION

It is understandable that many medical device start-up companies have limited resources and they do not have time to study the new MDR documentation as much in detail as they would like to. Many start-up CEOs are asking themselves now if it even possible to get the medical device CE mark in line with the new MDR requirements? The answer is “Yes you can!” You just need to know where to start the process.

Everyone in the medical device industry should know by now that the current medical device directive 93/42/EEC will be obsolete after 26th May of 2020. This means that start-ups planning to put their device after this date will face the challenges brought by the MDR (EU 2017/745). Your product development plans should therefore include detailed analyses of the life cycle phase of your medical device against the requirements of the new MDR. It is important to realize that the term life cycle means; “all phases in the life of a medical device, from the initial conception to final decommissioning and disposal”. Therefore, you must think about the certification process already during the initial brainstorming and concept development and choose the best regulatory route which will enable you a strategical and safe journey, from start to final decommissioning.

What is the main purpose of the new MDR? Like any other regulation its purpose it to allow safe devices to enter and remain on the European market. The possible clinical hazards for patients and users should be minimized as far as possible until a positive risk benefit analyses can be demonstrated. As a medical device manufacturer, you must keep this fact in mind at all times and let this be your guiding star when developing your technical documentation. Below we provide a brief overview of the eight-fold path that will generate detailed and solid technical documentation and lead to CE-mark. 

Step 1 – Define the Intended Use

It is surprising how often this is overlooked, but it is crucial that you define the intended use of your medical device correctly. The GHTF document (GHTF/SG1/N70:2011) defines intended use as;

“The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer”

The definition of medical device is given on the Article 2 of the MDR. Just document the intended use of your device and check if it falls under the medical device definition. In order to be categorized as a medical device “it shall not achieve its principal intended action by pharmacological, immunological or metabolic means, but may be assisted in its function by such means.”

MDR brings clarity to the categorization of sterilizers, washers and disinfectors. Furthermore, there are also some specific product categories given on Annex XVI, which do not have a medical intended use as defined on Article 2 but fall in the scope of the regulation.

Step 2 – Define the Risk Classification

There are 7 risk classes (III, IIb, IIa, Ir, Im, Is and I). These are based generally to the criticality and risks of the device on the patient, considering the mode of application, contact points, contact duration, invasiveness. 

Annex VIII of the MDR defines 22 rules and by using one of the 22 rules, you must define the risk classification of your device. Don´t forget that you must evaluate carefully the intended use against the content of each rule. The wrong definition of the risk classification will lead to the wrong selection of the conformity assessment procedure (certification route). 

Next to definition of intended use, the correct classification is one of the most crucial steps throughout your certification process.

Step 3 – Determine Correct Conformity Assessment Procedure

As explained above, the correct risk classification plays a crucial role within the certification process. Article 53 of the MDR defines the possible conformity assessment procedures which references the relevant Annex of the regulation. (Annex IX, X, XI …) The manufacturer must select the correct procedure and implement it.

Step 4 – Ensure the Safety of the Device

The design of the device must ensure the intended use and safety. You have to comply with the harmonized standards and common specification to achieve “state of the art” safety.

As defined in ISO 13485:2016 or any similar quality management system (QMS) standard, the design inputs shall cover the applicable regulatory requirements and standards. Therefore, the functional, performance, usability and safety requirements given on the applicable harmonized standards shall be considered as design inputs. These shall be verified and validated at appropriate stages and transformed into product specifications. The key point would be to have an effective design procedure, which clearly defines the review, verification, validation and transfer stages. You may benefit from a traceability matrix in order to demonstrate compliance to the each applicable GSPR (General Safety and Performance Requirements) given on Annex I of the regulation.

Step 5 – Develop the Technical Documentation 

MDR Annex II describes the requirements on the technical documentation. The technical documentation will be submitted to the notified body you have selected, and they will review that it is in line with the requirements for the selected conformity assessment procedure. Annex II specifies that the technical documentation shall be presented in a clear, organized, readily searchable and unambiguous manner, in other words, in an auditable format. Your technical documentation should prove that your device is safe and that it meets all the applicable requirements of the MDR. 

For most start-ups companies, the inclusion of clinical data into the technical documentation is the most challenging and costly element. Annex XIV or Annex XV specifies that you must present sufficient clinical evidence. The guidance document MEDDEV 2.7.1/Rev 4 is helpful to use as reference to successfully comply with the requirements of the both annexes. The Clinical Evaluation Report (CER) documents the conclusions of the clinical evaluation of your medical device. The CER consists of analyzed clinical data that was collected either from a clinical investigation of your device, or the results of other studies on substantially equivalent devices.

Step 6 – Implement an effective QMS

The conformity assessment procedure requires you to fulfill quality requirements. In order to fulfil these requirements, you may choose to implement a Quality Management System (QMS) compliant with the international standard ISO 13485:2016. 

Quality management is relevant because the safety of a medical device is not only dependent on the design of the device. Other product realization processes within the life cycle of the device also play a crucial role, such as purchasing procedures, vendor selection, manufacturing processes. Therefore, an effective QMS is essential to CE Mark your device.

The MDR also describes how you shall implement post market surveillance (PMS), post market clinical follow up (PMCF) and other vigilance requirements into your product feedback loop and regulatory reporting processes.

Step 7 – Submit to NB –Get Your Approval and CE Mark 

Devices classified as Is, Im, Ir , IIa , IIb and III will need the involvement of a notified body (NB) for the review of technical documentation and the certification process. Class I devices, however, may be put on the market with a valid (self) declaration of conformity, which shall be drawn up after finalization of the technical file and related QMS requirements. In many cases, the selected conformity assessment procedure requires an QMS site audit. 

Step 8 – Collect data and improve the design of your device

Remember that the desired CE mark is not the end of the story. After CE marking of your device you must continue to collect data by using PMS, PMCF, vigilance, change management and other relevant feedback processes in order to identify possible hazards related to the design and manufacturing processes of your device.

The MDR persistently emphasizes that you need to have effective review procedures in place to ensure that your device is safe throughout its entire life cycle. The data collected in the feedback process should be appropriately evaluated and necessary corrective actions shall be started in order to ensure the continued safety. Don’t forget to have effective notification procedures in place in order to inform your notified body about the significant changes since this is required by the regulation.

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