Before turning to the recommendation, we first look at the regulatory status of this medical equipment and the normal approval process to start selling it across the EU.
Medical devices vs PPE
PPE ranges from firefighters’ fire retardant jackets to safety helmets and footwear. PPE is also widely used in the health care sector and includes gloves, aprons, goggles, face visors and respirator masks.
Health care PPE is subject to the EU PPE Regulation3 and/or the EU Medical Device Regulation (MDR).4
Some products may appear to have a medical purpose, but in fact are designed to protect the user. Such products are usually considered to be PPE rather than medical devices. This will depend upon the intended purpose for the individual product concerned. For example, ionising radiation protective clothing, which is typically intended for the protection of health care professionals, will be PPE. Conversely, surgical masks (for use in an operating theatre) are medical devices as they are intended to protect the patient rather than the user. In the case of examination gloves, both the EU PPE Regulation and EU MDR could be applicable as they are intended typically by the manufacturer to be used to protect the patient (medical purpose and thus in scope of the EU MDR) and also to protect the health care professional (protection purpose and thus in scope of the EU PPE Regulation).
Normal pathway to market PPE and medical devices in the EU
The usual steps to commercialise medical devices under the EU MDR can be summarised as follows:
- Classify the device (low – medium – high risk)
- Pass a conformity assessment
- Draw up a declaration of conformity
- Place a CE mark on the device
- Correct labelling and instructions for use
- Assign a Basic UDI-DI and provide it to the UDI database
- Submit key information about the manufacturer, and supply chain partners, to the European database on medical devices (EUDAMED)
- Place your CE marked device anywhere in Europe
A similar approval and go-to-market process is applicable to PPE under the EU PPE Regulation.
One key step in the pre-marketing phase is the so-called ‘conformity assessment’. This is a specific process carried out by the manufacturer for demonstrating that the PPE or medical device conforms to legislative requirements laid down in the EU PPE and EU MDR before it is placed on the market. The end-goal is essentially to demonstrate compliance with health, safety and performance requirements, often by showing adherence to European product standards. The conformity assessment is proportionate to the risk class of the PPE or device. Such assessment can be done by the manufacturer itself (self-certification) for PPE falling in category I (PPE intended to protect users against minimal risks) or for medical devices in class I (devices with low or moderate risk to patient health and safety). For higher risk PPE or devices, the approval of notified bodies will be required. These are independent, private certification bodies designated by national authorities which perform third-party conformity assessment (e.g., TUV SUD, DEKRA, BSI).
After successful completion of the conformity assessment process, manufactures should place the CE mark on the medical equipment. By placing the CE mark on a product a manufacturer is declaring, on its sole responsibility, conformity with all of the legal requirements and standards under the EU PPE and EU MDR. Medical equipment that bears a CE mark can be freely marketed anywhere in the EU’s single market as well as in Norway, Iceland, Liechtenstein, Turkey, and Switzerland.
Accelerated pathway to market COVID-19 medical devices and PPE
In order to boost supplies of PPE and medical devices used by HCPs exposed to known or suspected COVID-19 patients, manufacturers are re-designing their supply chains by launching new manufacturing lines, putting in place virtual manufacturing contracts (i.e., own-brand labelling) and/or diversifying their supplier base.
The EU has now also taken measures in its March Recommendation to relax the regulatory approvals for PPE and medical devices described above – provided that safety is not compromised.5
These measures are:
- Opening the EU market to PPE manufactured in accordance with WHO guidelines rather than in strict compliance with EU harmonised standards, provided that they give a level of protection corresponding to EU requirements in the EU PPE Regulation and/or EU MDR.
- Notified bodies should prioritise and swiftly conduct the conformity assessment activities in the framework of all newly submitted requests by economic operators of PPE necessary for protection in the context of the COVID-19 outbreak.
- Member States can grant derogations from the conformity assessment procedures in the interest of the protection of public health,6 provided that they are only made available to HCPs.
- Market surveillance authorities can allow the free circulation of non-CE marked PPE for a limited period of time.
The scope of the recommendation is not clear and while the primary focus of the measures will obviously be class I medical devices (and equivalent PPE), there are arguments to make that they should also apply to higher risk devices.
Aside from relaxing the EU regulatory system for PPE and medical devices, the EU has taken a series of other measures to cope with possible supply shortages. For example, through its EU Civil Protection Mechanism,7 the European Commission will create a strategic ‘rescEU’ stockpile of medical equipment such as ventilators, reusable masks, vaccines, therapeutics and laboratory supplies, to help EU countries cope with the COVID-19 pandemic.8 The Commission has also launched the joined public procurement system with Member States to purchase critical medical equipment. This system was made possible by a tool established after the 2009 influenza pandemic. At the same time, the EU has imposed an EU-wide export ban on some medical protective equipment in a bid to keep sufficient supplies within the EU.9
Key takeaways
- Manufacturers of PPE and medical devices should assess if they have access to the accelerated process to get EU regulatory approval.
- Manufacturers should analyse national restrictions imposed in EU Member States and assess their validity under EU law (e.g., export restrictions, government emergency powers, public service obligations).
- Manufacturers should review their agreements in place with (critical) supply chain partners as well as contract manufacturers to assess the impact of EU measures taken to safeguard the supply of medical equipment, especially in case of putting non-CE marked products on the market.
- medtecheurope.org.
- Available at: eur-lex.europa.eu.
- Regulation (EU) 2016/425 of 9 March 2016 on personal protective equipment.
- Regulation (EU) 2017/754 of 5 April 2017 on medical devices.
- Customs, law enforcement and health regulatory authorities have already seen a rise in counterfeit facemasks, substandard hand sanitisers and unauthorised antiviral medication. See Interpol, 19 March 2020: interpol.int.
- Article 59 EU MDR (and its predecessor in the EU Medical Device Directive: Article 11 (13)).
- ec.europa.eu.
- ec.europa.eu.
- Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorization.
Client Alert 2020-129
