Insights

CE Marking according to the Medical Device Regulation

So what do you have to take into account to be allowed to place – or keep – medical devices on the European market under the new MDR? This blog post will briefly describe some of the important aspects, as well as some of the changes compared to the old EU regulation.

In 2017, the European Union adopted two new regulations for Medical Devices (MDR) and In Vitro Diagnostic medical devices (IVDR), respectively called Regulation (EU) 2017/745 and Regulation (EU) 2017/746. These regulations offer a legislative framework to bring medical devices on the European market, while ensuring patient safety and public health and supporting innovation. As it is a modernization of former regulation, potentially requiring important adjustments from medical devices manufacturers, a transition period until May 26th this year was offered. Because of the ongoing Covid-19 pandemic, the date of application has been further extended until May 26th 2021 for the MDR.

(Re)classification

First, it is important to determine whether the medical device product falls under the MDR or the IVDR. Medical devices include for example MRI scanners, pacemakers, hip replacements and adhesive plasters. With the new regulations, also products like contact lenses and software apps for medical use fall under the MDR. Examples of in vitro diagnostic medical devices are blood tests, reagents and pregnancy tests. Next, medical device products are categorized according to their invasiveness, duration of use and risk in Classes I, IIa, IIb and III. Annex VIII of the MDR lists the rules for this classification. This step is important, as with these new rules products may be classified in a different category than before, or fall under the MDR where they previously did not. If an existing product now falls in a higher category, additional clinical or technical data may be required. If a product falls in the Class I (self-certified) category, the regulatory process is considerably easier and does not require approval by a notified body. An important change is that reprocessing of single-use devices now has to comply to the same standards as the initial manufacturing of these devices.

 

Technical Documentation under the MDR

After determining the class of the product, a technical file should be compiled according to the respective MDR guidelines, which can be found in Annex II. For Class III devices this is called a Design Dossier.

 

The technical documentation includes the following aspects:

  • A device description and specification.
  • Information provided by the manufacturer, which comprises labeling information for the device and its packaging and user manuals in the official EU languages.
  • Design and manufacturing information.
  • General safety and performance requirements as outlined in Annex I. Previously, these were referred to as Essential Requirements (ERs), for which it is important to ensure this still matches for existing products. A Presumption of Conformity (Article 8) is included for medical devices for which harmonized standards exist.
  • A benefit-risk analysis and risk management plan (also found in Annex I).
  • Verification and validation information, which includes pre-clinical and clinical evaluation reports (CERs). This is of great importance for manufacturers, since the use of scientific literature for claiming equivalence is more strictly defined, and clinical evaluation is more aligned to clinical trials. Especially for implantable and Class III products, or for existing medical devices for which post-market surveillance has shown new insights, this can mean that additional clinical data has to be acquired. More information on clinical evaluation can be found in Chapter VI and Annex XIV part A of the MDR. A Post-Market Surveillance (PMS) plan (Chapter VII and Annex XIV part B). A new and important aspect of the MDR is the greater focus on Post-Market Clinical Follow-Up (PMCF) with the aim to continuously update the clinical evaluation of medical device products. Periodic Safety Update Reports (PSURs) will be required depending on the device type and class, and the time frame for reporting serious incidents has been reduced. If not yet in place, the regulatory and vigilance departments of medical device manufacturers might have to expand to meet these criteria.

 

Quality Management System

A Quality Management System (QMS) is essential for any medical device manufacturer and will already entail many of the aspects required for the Technical Documentation, such as the CERs and plans for PMS and PMCF. The vast majority of companies will use the ISO 13485:2016 Medical Devices, for which the transition period ended in March 2019. A more detailed discussion of the ISO 13485 according to the MDR will be discussed in a future blog post.

 

Regulatory Compliance, Traceability and Transparency

Each medical device manufacturer should appoint a Person Responsible for Regulatory Compliance (PRRC) according to Article 15. For companies outside the EU, an EU Authorized Representative (EUAR; Article 11) may be appointed to handle regulatory issues, which in turn will have a PRRC. Apart from manufacturers, also other players in the supply chain, such as distributors and importers, now have regulatory obligations.

 

Similar to the US market, the MDR imposes a new Unique Device Identification (UDI) system (Chapter III and Annex VI part C). UDIs will be provided by certified suppliers, and have to be specified on the device and/or its packaging. A UDI database still has to be set up, but documents endorsed by the Medical Device Coordination Group (MDCG) are already available. Additionally, a European Database on Medical Devices (EUDAMED) will be set up by the European Commission in collaboration with the MDCG (Article 33). This database aims to increase transparency, for instance by allowing the public to see which medical devices are available on the market and by facilitating traceability of devices. The database will include a registry of medical devices, the UDI system, economic operators, Notified Bodies and their issued certificates, clinical investigations, vigilance and post-market surveillance and general market surveillance. Since the UDI system and the EUDAMED are still under development, related regulation will not be immediately implemented in 2021. Instead, the provisional date of application for EUDAMED is May 26th 2022, and for the UDI requirements the same day in respectively 2023, 2025 and 2027 for implantable and Class III, Class IIa and IIb and Class I medical devices.

CE Marking Certification by a Notified Body and the Declaration of Conformity

All medical devices of Class I (sterile/measuring/reusable), Class IIa and IIb and Class III have to be audited by a Notified Body for obtaining CE marking certification. A Notified Body is a third-party company designated by the competent authorities to perform such audits. The selected Notified Body will review the Technical Documentation or Design Dossier, as well as the Quality Management System. If everything meets the MDR requirements, the Notified Body will issue the CE marking certificate for the medical device as well as the ISO 13485 certificate for the QMS of the facility. Additionally, the Notified Body is obliged to perform unannounced inspections at least every five years to the manufacturers and their suppliers. Since the ISO 13485 certificate has to be renewed every year, in practice Notified Bodies will probably combine both inspections.

 

For Class I (self-certified) medical devices, auditing by a Notified Body is not necessary. However, a QMS and technical file, including CERs and PMS are still required.

After obtaining the necessary certificates from a Notified Body, or in case of Class I (self-certified) devices, a Declaration of Conformity according to Annex IV can be issued, and it is officially allowed to place the medical device on the EU market!

Time frame

Knowing the aspects that have to be taken into account for placing a medical device on the EU market, it is important to make a plan to actually do so. A medical device manufacturer should appoint a PRRC, but of course other people involved should also be aware of all the necessary steps. It would be advisable to perform a gap analysis for all products, and to start gathering and creating the required technical information, especially if this includes additional clinical data. Responsibilities for PMS should be assigned in an early stage, to ensure availability of experienced staff. It should also be taken into account that Notified Bodies might have a high level of occupancy due to many companies having to deal with the transition at the same time.

 

As previously mentioned, the date of application of the MDR is May 26th 2021. On this date, newly introduced medical devices, as well as non-reusable, non-sterile and non-measuring Class I medical devices, will have to comply to the MDR. Currently CE-certified reusable, sterile and measuring Class I; Class IIa and IIb; and Class III devices will have additional time to comply to the MDR until May 26th 2024, unless the current certification expires before that date.