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A SHORT GUIDE FOR MEDICAL DEVICE START-UPS: HOW TO CE MARK YOUR MEDICAL DEVICE IN LINE WITH THE NEW MDR REQUIREMENTS?

The current medical device directive 93/42/EEC will be obsolete after 26th May of 2020.Medical Device start-ups, which plan to put their device after this date, will face the challenges brought by the MDR (EU 2017/745).

If you are a start-up aiming an initial certification after May 2020, you must take into account the changes in the European regulation. Your plan should include detailed analyses of each life cycle phases of your medical device against the requirements of the new MDR. Don’t forget; 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 have to start to think about the certification process during the initial conception and choose the best route which will enable you a safe journey till the final decommissioning.

The main purpose of the new MDR, like any other regulation is to have safe devices on the market. The possible clinical hazards for patients and users shall be minimized as far as possible till a positive risk benefit analyses is achieved. As a potential medical device manufacturer, you must keep this fact in mind and follow the basic steps listed below to generate a detailed, solid technical documentation.

Step 1 – Define the Intended Use

It’s very 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.

If you are familiar with the definition given in the MDD (93/42/EEC), you will notice that MDR brings clarity to the categorization of sterilizers, washers and disinfectors. 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

Annex VIII of the regulation defines 22 rules. 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. By using one of the 22 rules, you must define the risk classification. Just keep in mind 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). Therefore, correct classification is one of the most crucial steps throughout your certification process.

Step 3 – Select the correct conformity assessment procedure

As explained on the above step, correct classification plays a crucial role within the certification process. MDR defines the possible conformity assessment procedures on article 52, which references the relevant Annex of the regulation. (Annex IX, X, XI …) The manufacturer must select the correct procedure and implement it, as defined on the relevant annex in order to comply with the regulation.

Step 4 – Ensure the safety of your device (Design Assurance)

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 harmonised 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 SPR (General Safety and Performance Requirements) given on Annex I of the regulation.

Step 5 – Prepare the technical documentation

You have to prepare the technical documentation in line with the requirements of Annex II. You will use this during application to your notified body as required by the selected conformity assessment procedure. The first paragraph of the Annex II says; “The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex. “

In other words, it has to be documented in an auditable format and presented to your notified body. With your technical documentation you shall prove that your device is safe and meets the applicable requirements of the regulation. For most start-ups, inclusion of clinical data into the technical documentation might be challenging. You must present enough data according to Annex XIV or Annex XV as required. Meddev 2.7.1 Rev 4 may be used as an effective guidance in order to comply with the requirements of the both annexes. Don’t forget the technical documentation shall be a “controlled document” and updated throughout the life cycle of your device parallel to the design, manufacturing, regulatory or any other applicable changes.

Step 6 – Implement an effective QMS

The safety of a medical device is not only dependent on the design. Other product realization processes within the life cycle of the device, such as purchasing, incoming inspection, manufacturing, in process and final inspection play also a crucial role. Therefore, an effective Quality Management System imposed by all major regulations is essential to CE Mark your device.

In order to fulfil the QMS requirements given within your conformity assessment procedure, you may choose ISO 13485:2016. You must include PMS, PMCF and vigilance requirements of the regulation into your feedback and regulatory reporting processes.

Step 7 – Submit and get the approval

The intervention of the notified body to the certification process is required for devices classified as Is, Im, Ir , IIa , IIb and III. The class I devices may be put on the market with a valid 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. The duration of the review process is depended on the work load of the selected notified body.

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

After CE marking of your device you must 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.

You should have effective review procedures in place in order to ensure the safety of your device throughout all life cycle of your medical device. The data from the feedback process shall be evaluated and necessary corrective actions shall be started in order to ensure the continual safety. Don’t forget to have effective notification procedures in place in order to inform your notified body about the significant changes as required by the regulation.

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