The most difficult phase of the CE marking procedure, according to most manufacturers, is the notified body conformity evaluation. The overall configuration of the compliance evaluation technique is described in this article.
The primary goal of a compliance assessment
The main goal of a conformity assessment for the manufacturer is a notified body EC certificate stating that the producer can CE mark the medical equipment. A notified body EC certificate has a maximum validity of 5 years. This means that a typical compliance evaluation cycle lasts five years.
The MDR specifies the standards for notified body conformity evaluations. The fundamentals are covered in article 52, which refers to the three separate conformity evaluation methodologies described in annexes 9-11. The method of compliance evaluation is best defined in the notified body annex, appendix 7, section 4.5.
Requesting a compliance assessment
The manufacturer’s application to the notified body initiates the initial conformity evaluation. The notified body should be able to create a 5-year plan based on the application data that encompasses all of the planned activities for the forthcoming certification cycle.
First certification
A QMS onsite audit and an initial technical documentation examination are required for the first certification. The first step of the QMS audit consists of the notified body ensuring that the manufacturer’s QMS meets all applicable MDR standards. This audit duration is generally approximately 30% of the total first audit time.
The notified body decides when stage 2, or certification audit, can be done based on the results of the aforementioned audit. The initial TD assessment (Technical documentation assessment) must be communicated to the customer and form input to the stage 2 audit before the stage 2 audit is undertaken.
The timing might be difficult for the notified body at times, perhaps leading to delays. This is due to the fact that the outcome of the TD evaluation is based on the quality of the TD submitted by the manufacturer. As a result, it is strongly advised that all manufacturers provide only full and well-structured technical documentation.
The initial MDR EC certification
The notified authority can issue the first MDR EC certificate to the manufacturer after the stage 2 audit and completion of the following:
Any deviations have been handled.
The preliminary TD evaluation has been published.
Any possible substantial nonconformities identified during that examination have been resolved.
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.
Audits of annual surveillance
The first yearly surveillance audit must be performed by the notified entity within 12 months of the certification date. In connection with this audit, a TD evaluation should be undertaken once again.
The notified body’s requirement for the TD evaluation is that the technical documentation is sampled and assessed yearly until the whole range of the manufacturer’s devices is covered.
The depth of the TD evaluation must be the same for classes IIa, IIb, and III, according to MDCG 2019-13. Even if this is explicitly stated in this MDCG-endorsed paper, not all notified bodies follow this policy.
There will, of course, be a variation in the number of technical files to be called in since, for example, all class III devices must have their technical documentation examined at first certification, whilst lesser classes are sampled.
