Scope of the EC Guidance
As mentioned above, the present EC guidance is intended to provide all parties involved in operations with medical devices and personal protective equipment with additional clarifications on placing the aforementioned medicinal products on the EU market during the pandemic. The EC acknowledges that the COVID-19 outbreak resulted in a significant increase in demand on certain types of medical devices. In order to meet the demand and avoid shortages in the supply of vitally important medical devices, a lot of companies have entered the medical devices supply chains for the first time.
The guidance also describes requirements related to documents medical devices and personal protective equipment should be accompanied with. In particular, the EC describes certain approached to be used to identify falsified documents and counterfeit devices and PPE.
Regulatory Framework for Medical Devices and PPE
The EC outlines the legislation in the sphere of medical devices and personal protective equipment. According to the guidance, the medical devices falling under the scope of the document are currently regulated by:
- Active Implantable Medical Devices Directive 90/385/EEC dated 20 June 1990 (AIMDD),
- Medical Devices Directive 93/42/EEC dated 14 June 1993 (MDD),
- In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).
At the same time, it is also important to mention that the aforementioned Directives would be soon replaced by the new Regulations, namely:
- Medical Devices Regulation 2017/745 dated 5 April 2017 (MDR), and
- In Vitro Diagnostic Medical Devices Regulation 2017/746 dated 5 April 2017 (IVDR).
The scope of the guidance also covers personal protective equipment regulated under the Personal Protective Equipment Regulation 2016/425 dated 9 March 2016 (PPER).
Placing Medicinal Products on the EU Market
The EC guidance also describes the procedures to be performed in order to place medical devices and personal protective equipment on the EU market. In accordance with the document, all medicinal products should be duly CE-marked under the appropriate declaration of conformity issued and signed by the manufacturer.
Both Directives and Regulations set forth general safety, performance, and effectiveness requirements medical devices and PPE should meet. At the same time, the aforementioned documents do not establish a particular way the compliance with these requirements should be achieved by the manufacturer. Thus, the manufacturer of medical devices or PPE is allowed to use any technical solution they will find suitable providing that the medicinal product will meet the appropriate requirements. For example, the manufacturer may use harmonized European standards describing the particular technical solutions to be implemented to maintain compliance with the applicable requirements. In a case the medical device or PPE in question is being manufactured in accordance with the harmonized European standard, it would be deemed as compliant with the safety, performance, and effectiveness requirements.
The present EC guidance also describes additional obligations and responsibilities of the medical device / PPE manufacturers, including, inter alia, the following ones:
- According to the guidance, the manufacturer of the device shall duly document all technical measures and solutions used in its product and be able to provide such information to the regulating authorities upon demand.
- Medical device manufacturers residing outside the European Union shall designate an authorized representative. The information about the representative shall be indicated in the declaration of conformity issued and signed by the manufacturer, and also in the labeling of the device.
- In some cases, the manufacturer shall apply for the conformity assessment to be performed by the notified body duly designated by the appropriate national authority. It is also important to mention that the medical device in question shall fall within the scope of the designation of the particular notified body. As a result, the notified body will issue the appropriate certificate confirming that the medical device complies with the applicable safety and performance requirements.
Admissible Documents for Marketing Medical Devices Within EU
The EC guidance also provides additional clarifications on the documents accompanying medical devices or personal protective equipment intended to be marketed in the EU. In particular, the EC states that any document should be explicitly indicated in the applicable regulation, while any other documents could not be used to justify placing the medical device or PPE on the EU market. For example, it is not allowed to refer to such documents as:
- “Certificate of compliance”,
- “Attestation of compliance”,
- “Certificate of conformity”,
- “Certificate of notification”,
- “Certificate of registration”,
- “Documentation review”.
Any of the aforementioned documents does not constitute a valid and admissible document allowing to place the medical device or personal protective equipment on the European market. The EC also additionally emphasizes that the document should be issued only by the notified body duly designated to carry out the conformity assessment under the appropriate regulatory framework (either Directives or Regulations) in accordance with the scope of designation.
The number of notified bodies already designated to perform conformity assessment under the new Regulations seems to be insufficient to meet the increasing demand on conformity assessment due to the numerous requests for initial certification of new medical devices or renewal of the existing certificates. To avoid shortages in supply and ensure the availability of vitally important medical devices, the EC has already announced additional extraordinary and temporary measures introducing certain amendments to the legal procedures related to the designation of notified bodies.
Requirements for the Declaration of Conformity
The EC also describes the requirements the declaration of conformity issued and signed by the medical device / PPE manufacturer shall meet. In particular, the declaration of conformity should contain:
- The information sufficient to identify the product, as well as its detailed description,
- The references to the applicable EU regulations,
- The information about the manufacturer and its authorized representative (in case of the foreign manufacturer), including their names and addresses,
- The special statement indicating that the declaration has been issued under the sole responsibility of the manufacturer,
- The description of the conformity assessment procedures performed,
- The references to the applicable harmonized European standards the medicinal product in question is compliant to,
- The indication of the name and identification number of the notified body responsible for the certificates issued (if applicable),
- The indication of the particular date the declaration has been issued.
The EC states that the declaration of conformity should contain references to any and all applicable European legislative acts. Thus, in case if the medical device in question falls under the scope of regulation of several acts, all of them should be duly indicated in the declaration of conformity.
Summarizing the information provided hereabove, the present EC guidance describes in detail the requirements the documents accompanying medical devices and personal protective equipment shall meet.
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