According to most manufacturers, the notified body conformity assessment is the most challenging part of the CE marking process. This article outlines the general setup of the conformity assessment procedure.
This video is an excerpt from the online course Introduction to the Medical Device Regulation (EU) 2017/745 which covers an orientation of the MDR and related guidance documents such as the MDCG and how to apply for a conformity assessment.
For the manufacturer, the main objective of a conformity assessment is a notified body EC certificate that states that the manufacturer can CE mark the medical device. The maximum validity of a notified body EC certificate is 5 years. This means that a normal conformity assessment cycle is 5 years.
The MDR requirements for notified body conformity assessments are spread out in the MDR. The basics are found in article 52, which references the three different conformity assessment procedures in annex 9 to annex 11. How the conformity assessment is done is best described in the notified body annex, annex 7 under section 4.5.
And remember that any new or changed devices must now conform to all MDR requirements according to article 120 of the MDR.
The start of the initial conformity assessment is the manufacturer’s application to the notified body. Based on the application data, the notified body should be able to set up a 5-year plan that covers all the planned activities for the upcoming certification cycle.
Initial certification requires a QMS onsite audit and an initial technical documentation assessment. The initial QMS audit is composed of a stage 1 audit where the notified body ensures that the manufacturer’s QMS covers all applicable MDR requirements. This audit duration typically consists of around 30% of the entire initial audit time.
Based on the output of the audit above, the notified body decides when the stage 2, or certification audit, can be conducted. Before the stage 2 audit is performed, the initial TD assessment (Technical documentation assessment) shall be reported to the client and form input to the stage 2 audit.
The timing can sometimes be challenging for the notified body and potentially lead to delays. This is because the output of the TD assessment is dependent on the quality of the TD sent in by the manufacturer. Therefore, it is recommended that all manufacturers send in only complete and well-structured technical documentation.
The first MDR EC certificate can be granted to the manufacturer by the notified body once the stage 2 audit has been performed and the following have been completed:
The extent of the initial and coming audit activities performed by the notified body depends on the size of the manufacturer and the scope of their QMS. For a manufacturer with approximately ten employees (also called FTE, full-time equivalents), the initial audit will take somewhere around five days in total. For a manufacturer with 100 employees, it will take approximately ten days.
The amount of technical documentation to be sampled depends on the product portfolio range and classes but also on the diversity. This is because sampling is done depending on the difference between the products covered by the certificate.
Within 12 months of the certification date, the notified body needs to perform the first annual surveillance audit. Once again, there should be a TD assessment performed in conjunction with this audit.
The notified body’s requirement with regards to the TD assessment is that the technical documentation shall be sampled and assessed yearly until the full range of the manufacturer’s devices has been covered.
According to MDCG 2019-13, the depth of the TD assessment shall be the same for class IIa, IIb, and III. Even if this is clearly stated in this MDCG endorsed document, this is not always the case with all notified bodies.
There will, of course, be a difference in the number of technical files to be called in since, for example all class III devices need to have their technical documentation assessed at initial certification whereas lower classes are sampled.
For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, there is also a requirement to go through a clinical evaluation consultation procedure.
This means that the notified body has to send their clinical evaluation assessment report of the manufacturer’s clinical evaluation to a designated expert panel for a ”second opinion” and their recommendation.
When the manufacturer’s full range of devices has been assessed by the notified body (through TD assessment) during the certification cycle, and there is still time left on the certification cycle, the notified body shall focus on the technical documentation relating to post-market surveillance during the upcoming remaining audits in that cycle.
So, when no more TD sampling is to be done, the focus during audits will be PMS-related documentation.
Future surveillance audits shall also be done within 12 months after the previous audit. These surveillance audits shall also cover potential critical supplier audits as decided and included in the notified body’s audit program. A supplier audit can also be required with the initial stage 2 audit. In addition, the notified body shall do at least one unannounced audit during each certification cycle.
During the certification cycle, the manufacturer is obliged to report changes in their QMS and in their product portfolio to the notified body. Any potential vigilance and the mandatory PSURs shall also be reported to the notified body. This information also serves as input to the notified body’s 5-year plan. Changes can be potential triggers for extra TD assessments, special assessments, extra audits, or unannounced audits.
The notified body can also do unannounced audits of the manufacturer’s suppliers. Unannounced audits under the MDR normally include that the notified body performs or witnesses actual product tests.
Before the end of a certification cycle, the notified body will need an application from the manufacturer to request re-certification. This application can be as extensive as the initial formal application, but not necessarily, depending on potential changes.
The notified body needs to perform a re-certification audit to prolong the EC certificate with a new 5-year validity. Before the certificate gets a new 5-year validity, the notified body must ensure that everything according to the initial 5-year plan has been performed and managed correctly.
When the manufacturer requests a re-certification, the notified body also needs to set up a new 5-year plan for the activities for the coming certification cycle. This needs to include everything that was in the first cycle, meaning calling in technical documentation and performing new regular and unannounced audits.
That was the generic process of a conformity assessment and the process to CE mark a medical device. If you would like to read more similar articles, take a look at our other medical device articles.
If you want to know more about understanding the European regulation for medical devices, take a look at our online Introduction to the Medical Device Regulation (EU) 2017/745 course. This online course is an in-depth overview of the Medical Device Regulation according to (EU) 2017/745 as well as related guidances, like MDCG, and how to apply to a notified body for conformity assessment.
It is suitable for anyone working with regulatory questions, such as RA and QA engineers, PRRC or management.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has vast experience in the MDR and its implementation thru hands-on experience from implementing the MDR at a notified body and leading that notified body through a joint assessment and getting designated as an MDR notified body.
He was a senior manager at a notified body during the transition from MDD to MDR and also a member of the NB-MED group.
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