The Guidance provides a list of relevant information concerning the regulations governing medical devices, active implantable medical devices and IVDs and potential related derogations in the light of the public health crisis associated with the COVID-19 pandemic. The guidance includes specific information on EU harmonised standards for medical devices, active implantable device and IVDs, derogation procedures available at EU Member State level, off-label use of devices, and registration of devices with competent authorities. The Guidance also discusses the recent European Commission's proposal to postpone the application date of the MDR by one year. The guidance is provided in a question-and-answer format that is easy to read.
Harmonised standards with relevance to COVID-19
In Annex I to the Guidance, the European Commission provides a list of EU harmonised standards that are considered to be most relevant in light of the public health crisis associated with the COVID-19 outbreak. This includes, for example, EU harmonised standards for medical face masks, medical gloves or respiratory therapy equipment. The Guidance recalls the possibility for manufacturers to download several of these standards free of charge from the online catalogues of the national standardisation bodies.
In Annex II to the Guidance, the European Commission provides a link to a table indicating recognition of international standards under the legal systems of the member jurisdictions of the International Medical Device Regulators Forum (IMDRF).
Derogation procedures available at EU Member States' level
Article 11.13 of the Medical Devices Directive, Article 9.9 of the Active Implantable Devices Directive and Article 9.12 of the IVD Directive provide EU Member States with the possibility to authorise derogations from normal conformity assessment procedures. The Guidance references the recently published Commission’s Recommendation (EU) 403/2020 on conformity assessment and market surveillance of 13 March 2020 and guidance document on conformity assessment procedures for protective equipment which lay down recommendations for national competent authorities when assessing a request for derogations from normal conformity assessment procedures.
In addition, the Guidance provides that, when assessing the need for a derogation, EU Member States' competent authorities should consider the following factors:
- The degree of criticality of the use of the device for the protection of health;
- Availability of suitable substitutes;
- Documentation of compliance with harmonized standards or other specific technical solutions ensuring fulfilment of the applicable essential requirements laid down in the relevant Directive;
- Review of reports of tests performed by competent bodies;
- Indications of vigilance and/or market surveillance.
The Guidance also provides that such derogations should be temporary. The duration of their validity should be limited to what is strictly required for rendering the device compliant with the legislation or, if earlier, when suitable substitutes can be expected or the critical needs will no longer be present.
Furthermore, the Guidance emphasizes the importance of appropriate market surveillance measures and stresses that EU Member States need to be cautious with regard to falsified certificates and counterfeit devices.
Registration of devices
The Guidance provides that in most cases manufacturers who make devices available on the EU market are required to register with the competent authorities of EU Member States in which the manufacturer has its registered place of business. For manufacturers based outside the EU, this registration is conducted by the manufacturer's EU authorised representative.
When it is deemed necessary to use an existing CE marked device for a purpose that is different from that intended by the manufacturer in the instructions for use of the device, the Guidance provides that risks and benefits to the patient must be assessed and include the following steps:
- A documented risk assessment on the use of the device;
- Consideration of ethical and legal implications;
- Implementation of suitable precautions to minimize risk;
- Reviewing the risk assessment at suitable periods;
- Obtaining approval from national competent authorities when required.
European Commission's proposal for postponement of the application date of the MDR by one year
The Guidance mentions that on 3 April 2020, the European Commission adopted a proposal to postpone the date of application of the MDR by one year. The European Commission submitted a related proposal to the European Parliament and Council on 3 April 2020 with the aim to have the proposal adopted before 26 May 2020.
Authored by Elisabethann Wright, Hélène Boland, and Vicky Vlontzou