CE mark is required for each medical device sold in EU. Due to the Covid-19 pandemic the date of application of the new EU medical device regulation (EU 2017/745) has been postponed to 26th May 2021. Until this date, Medical Device Directive 93/42/EEC may be still used for the initial certification.
A medical device which will be put on the EU market for the first time has to be CE marked. Currently there are two possibilities for this process. Firstly, legal manufacturer may use medical device directive 93/42/EEC (or 90/385/EEC for active implantable devices). Secondly, he may choose an appropriate conformity assessment procedure from MDR (EU 2017/745). I would recommend selecting the second option. Although compared to March -May 2020 period things are much better nowadays, nobody knows when or how a second wave of pandemic will hit Europe. Even if everything will go fine, notified bodies will most probably stop their initial certification quotations latest November 2020 as they did during autumn 2019. So, if you are still at the beginning phases of your CE marking project, the remaining 6 months (at the date of this article) of the additional year will be not enough for you. If you are new to the process, with 200+ pages MDR may frighten you. Don’t worry, a detailed plan and dedicated team can overcome each obstacle.
Your plan for MDR certification should include detailed analyses of each life cycle phase 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 must 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 safe devices on the market. The possible clinical hazards for patients and users shall be minimized as far as possible within a risk management process implemented in line with ISO 14971:2019.The crucial limit is a positive risk benefit analysis. As a 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”
Just document the intended use of your device and check if it falls under the medical device definition given on Article 2 of MDR. 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 medical device 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 according to the EU Medical Device Regulation
Annex VIII of the new EU Medical Device Regulation lists 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. The rules consider mainly the mode of application, contact points, contact duration, invasiveness. By using one of the 22 rules, you must define the risk classification of your device. Just keep in mind that you must evaluate carefully the intended use, against the content of each rule one by one. 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. For convenience you may ask the below questions in the given order and evaluate the answers by checking the rules given on chapter III of Annex VIII.
- Are there any special rules concerning my medical device? (Rules 14 to 22)
- Is it an active device? (Rules 9 to 13)
- Is it an invasive device? (Rules 5 to 8)
- Is it a non-invasive device? (Rules 1 to 4)
If more than one rule is applicable to your device, you have to consider the highest risk class.
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 – 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 (e.g. Annex IX), 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 5 – Ensure the safety of your device (Design Assurance)
The design of the device must ensure the intended use and safety. You need 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 GSPR (General Safety and Performance Requirements) given on Annex I of the regulation.
Step 6 – Prepare the technical documentation
You must 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 must 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 manufacturers, inclusion of clinical data into the clinical evaluation report might be challenging. You must present enough data according to Annex XIV or Annex XV as required. MDCG guidance documents and Meddev 2.7.1 Rev 4 may be used as an effective tool 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 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 can 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 on-site QMS 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. Especially for an effective PMCF process you may make use of the MDCG Guidance Documents 2020-7 and 8.
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.