The CE Mark Certification for Medical Devices

As a medical device (MD) manufacturer, you should realise from the onset: your company’s products are subject to clinical trials and approval processes with regulatory bodies in, potentially, Europe, Asia, USA and the rest of the world.

Your device and CE Marking

The business model and implementation of the Product Development Life Cycle (PDLC) of your medical device will have to consider all the pertinent regulatory demands. Remember that the successful outcome of a PDLC for your device is not only a finished device but also the complete documentation demanded by regulatory agencies! And it is only after the latter are satisfied that you have met all of their regulatory requirements that they will approve your device for sale in the national medical markets they supervise.

In the Europen Union (EU), you can sell your medical device only if you acquire a valid CE (Conformité Européenne) Mark for it. Once you have the latter, you can offer your product in 32 European countries. The CE is not a mark of your device’s quality! It is confirmation that your device satisfies all the specific safety standards, efficacy, quality, and performance that the EU enforces for your medical product type.

So I file everything only at the EU level?

Not exactly.

Formally, MDs are regulated at Member State level, which should be, of course, in compliance with EU Directives. Medical device manufacturers must undergo conformity assessments with an EU member’s notified body to demonstrate that they meet legal requirements for device safety and performance as intended.

Conformity assessments also include an audit of your quality system and technical documentation of your device’s performance and safety. Only after you have passed the mentioned appraisal will you be allowed to place a CE mark on your device. There are specific medical devices that you, as the manufacturer, can certify yourself, without a notified body.

In the last step, you have to complete an additional filing for national requirements compliance with all EU National Competent Authorities to gain national markets access.

So, obtaining a CE Mark is costly and complicated?

Not exactly.

There are seven stages in obtaining a CE marking for your medical device:

  • Device Classification;
  • Requirements Identification;
  • Compilation of Technical Documentation;
  • Appointment of a European Authorized Representative; (For non-EU manufacturers; in line with EU Medical Device Directive 93/42/EEF Article 14.2);
  • Device Certification;
  • CE Marking Attachment;
  • National Provisions Compliance.

A long-form description

As a manufacturer, you should first characterise your MD as “what the device is supposed to perform” and “how does it achieve this”.

This classification is decisive as it defines your device’s type in light of the EU Directives and legislation. The former mandates all the specific regulations with which your product must comply.

In the next stage, you identify all relevant European Harmonised Standards and additional safety and health mandates. Now is the time to check whether you need Notified Bodies or not to obtain CE Marking.

Regulators will not issue CE Marking permission without you, the manufacturer, furnishing them with the required technical documentation. The latter includes product inspections, relevant audits, assessments and medical device tests. You must also issue a valid Declaration of Conformity and disclose your Technical File whose copy must always be available for any EU Competent Authority to inspect.

If you do not have a registered address in the EU, you must appoint your European Authorized Representative (EAR). If your MD is in one of the higher device categories, you have to ask a Notified Body to audit your technical documentation. After receiving your MD certification, you must attach, visibly, the CE Mark on your device, its user documentation, and its packaging.

To finally gain market-entry approval in specific EU countries, you must file for supplemental registration with National Competent Authorities.

Notes

Not all devices demand an assessment process that involves Notified Bodies. Check whether your product is one of the latter! You can, as a manufacturer, taking full responsibility, carry out a conformity assessment yourself if your device falls into one of three groups:

  • Class I classical medical devices (without a measuring function; non-sterile);
  • Custom-made products (intended for the individual patient);
  • Treatment units and systems (assembled from compliant accessories and medical devices);

Which changes does MDR introduce?

The new Medical Device Regulation (MDR), in effect from the 21st of May 2021 in the EU, introduces more exacting requirements for certain MD types. The latter may affect the Product Development Life Cycle (PDLC). For some instances, new classification rules can push a device to a higher level, increasing the amount of clinical data a manufacturer must present.

Furthermore, MDR compels manufacturers to collect and analyse more data regarding device performance, safety and quality than before, and do so during the whole PDLC.

MDR’s greater focus on post-market surveillance also increases the manufacturer’s obligation to gather and analyse data on the device’s quality, performance, and safety throughout the product life cycle.

Simultaneously, technical documentation stipulations and GSPR (General Safety and Performance Requirements) are now broader. MDR also brings a novel pre-market inspection process for high-risk devices, typically demanding longer and more challenging conformity assessments.

Some product types will have generally higher requirements thresholds, such as implants, nanoparticles and, interestingly, products that contain software or are a software product of themselves.

MDR has undoubtedly made the times interesting for manufacturers.

For more information on matters of the CE Mark, see “Regulation (EU) 2020/561 of the European Parliament and of the Council of the 23rd of April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions”:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.130.01.0018.01.ENG&toc=OJ:L:2020:130:TO

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