How to obtain a CE mark for a medical device
In order to place a medical device on the EU market, it must comply with all applicable EU directives and successfully undergo a conformity assessment procedure. Conformity is then made visible by a CE mark on the medical device.
Medical devices are regulated in the EU under the following directives:
- Directive on active implantable medical devices 90/385/EEC (AIMD)
- Directive concerning medical devices 93/42/EEC (MDD)
But the directives have already reached their expiration date: In May 2017, the new regulation on medical devices (MDR) came into force. The MDR will replace the existing MDD and AIMD directives (AIMD will be abolished and integrated into the MDR), and an implementation period of 3 years (MDR) was agreed by setting the enforcement date to May 2020.
For the purpose of conformity assessment procedures, medical devices are grouped into four risk classes. The classification rules are based on the vulnerability of the human body and considers the potential risks that are associated with the technical design and manufacturing of the devices. Only medical devices of the lowest risk class do not need to involve a notified body in the conformity assessment procedure. Notified bodies are independent, state-authorized third-party companies that carry out the conformity assessment on behalf of the medical device manufacturers. The manufacturer is free to choose the notified body as long as the notified body is accredited by the competent authority in the relevant EEA state, Switzerland, or Turkey and has the relevant product group within its scope. Information on the notified bodies can be found in the information system NANDO (New Approach Notified and Designated Organisations).
The risk class determines the conformity assessment route
In Europe, medical devices are divided into four risk classes: Classes I, IIa, IIb, and III. The designation as Class I, IIa, IIb or III is made according to Annex 9 of Directive 93/42/EEC. Product information must always be taken into account. Moreover, similar products may belong to different classes, depending on the intended use, the duration of use, and the anatomical position of the product. Depending on the risk class, the conformity assessment can be carried out by the manufacturer or the assessment as well as periodic controls must be carried out by a notified body. Manufacturers of the devices of all risk classes have to compile a technical documentation to prove the fulfilment of the safety and performance criteria, as outlined in the essential requirements.
The CE mark under the EU Medical Device Directives
Once the risk class has been determined, the manufacturer can choose from different conformity assessment procedures as outlined in Article 11 of the MDD.
|Class I devices (non-measuring/ non-sterile)||Class I devices that are sterile or have a measuring function||Class IIa||Class IIb||Class III|
|EC Declaration of Conformity as outlined in Annex VII||Full quality assurance system as outlined in Annex II (excluding section 4)||Full quality assurance system as outlined in Annex II (excluding section 4)||Full quality assurance system as outlined in Annex II (excluding section 4)||Full quality assurance system as outlined in Annex II (including section 4 – examination of the product)|
|Annex VII plus Annex IV (EC Verification), V (Production quality assurance) or VI (Product quality assurance)||Annex VII in plus Annex IV (EC Verification), V (Production quality assurance) or VI (Product quality assurance)||Annex III (EC Type Examination) in combination with Annex IV, V or VI||Annex III (EC Type Examination) in combination with Annex IV or V|
Following the Annex II conformity route, the notified body issued two certificates after a successful audit, the QMS certificate and the CE certificate. Annual surveillance audits are conducted by the notified body. After the successful conformity assessment, the manufacturer places the CE mark on the products and issues a Declaration of Conformity for the respective product, attesting that the products conform to the Essential Requirements in the applicable European directive for medical devices (93/42/EEC, 90/385/EEC).Most manufacturers of devices higher than risk class I choose the conformity assessment route according to Annex II, also called the full quality assurance system. The notified body reviews the technical documentation according to the regulatory requirements in the directives and the quality management system (according to the harmonized standard ISO 13485). Depending on the risk class the audit includes the review of the technical documentation or design dossier, to ensure that adequate design controls are in place, and that the established process to create and maintain a technical documentation/design dossier is adequate.
Manufacturers often choose Annex II because it simplifies CE marking for its other devices that need the involvement of a notified body for the conformity assessment. It often is a decision that depends on whether a quality management system is already in place.
Conformity assessment carried out by the manufacturer
Under the sole responsibility of the manufacturer, the following medical products are marked with a CE mark without an identification number:
- Custom-made products (specifically manufactured for one patient)
- Systems and treatment units (composed of compliant medical devices and accessories according to the manufacturer’s instructions)
- Class I classical medical devices (non-sterile and without measuring function)
The manufacturer is responsible for ensuring that its products comply with the legal requirements and declares the conformity in a Declaration of Conformity. Manufacturers or authorized representatives of Class I medical devices are obliged to notify Class I medical devices to the national competent authority.
Conformity assessment carried out by a notified body
The following medical devices require an assessment and periodic review by a notified body:
- Class I sterile medical devices (Is)
- Class I medical devices with measuring function (Im)
- Class IIa, IIb and III medical devices
- active implantable medical devices
A successful conformity assessment by the manufacturer presupposes that the product meets all applicable essential requirements. Written evidence of this must be available for each product (such as technical documentation and batch records). Products that were assessed with the involvement of a notified body are marked with a CE mark and the identification number of the responsible notified body.
For medical devices containing medicinal substances the notified body carries out the necessary consultations with national or European authorities (consultation procedure).
The CE mark under the Medical Device Regulation – what are the changes?
While the MDR introduces stringer requirements and changes that impact the entire lifecycle of medical devices, the conformity assessment procedures remain essentially the same. Manufacturers still need to conduct a conformity assessment before placing their devices on the market, and for higher-risk devices, the involvement of a notified body is required. In the MDR, Article 52 outlines the conformity assessment procedures, and the respective annexes have been renumbered and renamed (Annexes IX to XI).
Some of the key changes are listed below:
- A new Class Ir for reusable surgical instrument has been introduced to control the safety regarding the reusable characteristics of surgical instrument. This class also requires a notified body to assess the quality management system that manages this specific feature.
The MDR introduces new classification rules that may lead to a higher classification of devices than the MDD did, leading to an increase in the amount of required clinical data. A focus on post-market surveillance increases the manufacturer’s obligation to gather and analyse data on the quality, performance, and safety of the device throughout the entire product life cycle. The quantity of requirements outlined in the MDR’s general safety and performance requirements (so called GSPR) has significantly increased along with the requirements for the technical documentation.
The ‘full quality assurance route’ will be replaced by the ‘conformity assessment based on quality system assurance and assessment of the technical documentation’ in Annex IX. Moreover, the MDR introduces a new pre-market scrutiny process for high-risk devices. Conformity assessment procedures will generally be more demanding and are also likely to take longer, especially in cases where notified bodies have to consult health authorities and EU expert panels for the assessment of high-risk devices. The MDR does not provide timelines for reviews by notified bodies.
For some product types, the new regulation has particularly tightened the hurdles. These include products that contain nanoparticles or drugs, implants, and products that contain software or are software, as well as products belonging to the class of the newly introduced risk class Ir (reusable surgical instruments).
If you are not sure whether the medical device framework is applicable for your product and therefore subject to the here outlined conformity assessment, this might interest you.
If you want to know more about the applicability of the regulations to medical software, you might be interested to read this post.
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