European Commission Recommends Regulatory Midway For COVID-19 Products
The EU is addressing the regulatory obstacles that threaten to reduce the speed at which vital products needed to treat COVID-19 are produced.
European Commission tells medtech to use existing derogation article for COVID-19 products
Measure to allow some non-CE-marked products to circulate on market and be purchased at member state level
Recommendation applies to UK
Commission advises industry in time of need to make use of non-prescriptive EU medtech rules
Measures to help speed the time to market of medical devices and personal protective equipment (PPE) are contained in a Commission recommendation on the conformity assessment and market surveillance procedures within the context of the COVID-19 threat.
The most important message in this recommendation for medical devices is the reminder that EU member states have the possibility to authorize derogations from conformity assessment procedures. They can do this in the context of Article 11 (13) of the Medical Devices Directive, and Article 59 of the Medical Device Regulation, which fully applies on 26 May.
The commission recognizes that economic operators are redesigning their supply chains by launching new manufacturing lines and/or diversifying their supplier base. “These efforts by the industrial stakeholders would not be able to produce their full effects if the increased supply cannot feed into the market without any undue delays,” it says.
The European Initiative For All Products Needed
This is one more weapon in the EU’s armory against the virus. Commission President Ursula von der Leyen has called on member states to ramp up the production of medical equipment and share those goods within the bloc. She said no country had the capacity to produce on its own what will be needed to treat patients in the fight against coronavirus.
The commission will also launch a joint public procurement system with member states for testing kits and respiratory ventilators.
The UK’s Association of British HealthTech Industries (ABHI) believes that this recommendation is equally relevant to the UK as to the EU27.
While the primary focus of the document seems to be Class I medical devices, there is nothing to suggest that the document does not also apply to higher risk devices, such as ventilators. Gert Bos, executive director and partner at Qserve consultancy confirmed that, in his view, the core recommendation applies to all medical devices needed to battle the virus.
“This may for example mean that countries can decide that after May 26 products that previously had the CE mark but did not make it into MDR or grace period, could be accepted in their specific country,” he explained.
Bos said that several notified bodies have already committed to prioritize any review related to COVID-19 products, and that consultancies like his have been prioritizing such products as have agency services confirming class I registrations.
Non-CE-marked Products Can Continue On EU Market
EU market surveillance authorities should urgently focus on non-compliant PPE or medical devices raising serious risks for users, the recommendation says.
Where authorities find that such devices are sufficiently safe even though the conformity assessment procedures, including the affixing of CE marking have not been fully finalized, they can authorize the making available of these products on the EU market for a limited period, and while the necessary conformity assessment procedures are being carried out.
Non-CE-marked PPE or medical devices could also be assessed and be part of a purchase organized by member state authorities, provided they are only available for health care workers for the duration of the current health crisis, and that they are not entering the regular distribution channels and made available to other users.
Market surveillance authorities should inform immediately the commission, and other member states of any temporary arrangement they have granted to specific PPE or medical devices, the recommendation says.
Notified Bodies Must Prioritize COVID-19 Products
The recommendation tells notified bodies that assess PPE that they should “prioritize 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.”
Since notified bodies are not involved in the majority of Class I medical devices, which are the focus of this recommendation, the same advice is not relevant for the medtech industry.
Article 59 allowing member states to authorize derogations applies equally when a notified body is not involved in the conformity assessment of a product, i.e. in terms of class I products.
No Detrimental Effect On Safety
The commission asks all economic operators, notified bodies and market surveillance authorities to do their utmost to ensure the supply of medical devices and PPE throughout the EU market will match the continuously increasing demand.
But it emphasizes that these measures should not have a detrimental effect on the overall level of health and safety, and all relevant stakeholders should ensure that all medical devices and PPE continue to provide “adequate levels” of health and safety protection for users.
UK Position Unclear
As the recommendation relates to legislation that is in force in the UK up until the end of the year, when the Brexit withdrawal agreement period is supposed to end (although that is currently in question), the ABHI assumes it applies directly to the UK, as does the regulation restricting exports of PPE from the EU, Phil Brown director, regulatory and compliance, told Medtech Insight.
“I know that this particular document is uppermost in the MHRA’s mind – and is the basis in many ways, for the publication of the UK’s ventilator challenge,” said Brown. (Also see “UK Ventilator Portal Established In Bid To Have 20,000 More Ventilators” – Medtech Insight, 18 Mar, 2020.)
Recommendations are not binding on member states, Clive Powell, outgoing senior manager, regulatory and compliance at the association, emphasized, so it will be up to the UK to choose whether to follow this document. (Powell is leaving ABHI in April after 30 years and is currently deciding on his future direction.)
The recommendation also makes the point that the MDD and MDR already allow a degree of flexibility when it comes to making new products available, as the regulations are non-prescriptive. They are “technologically neutral and do not lay down any specific mandatory technical solutions to tell manufacturers exactly how to comply with the essential requirements/general safety and performance requirements which devices need to meet to be placed on the market,” it said.
It also makes the point that standards are not mandatory and manufacturers are free to choose other technical solutions provided that the chosen solution ensures the medical device complies with the applicable essential health and safety requirements.
But for manufacturers who chose to comply with harmonized standards, those products will be presumed to be in conformity with the relevant requirements in the MDD/MDR.
It also makes the point that Class I products do not normally need the involvement of a notified body.
Little Known Article Jumps Into Spotlight
Article 59 is also the article that is being cited as the way that member states can allow safe products to remain on the market in case companies have been unable to get them certified in time for compliance with the MDR.
To date there has been very little experience of using Article 11 (13), the predecessor in the MDD to Article 59 in the MDR, but suddenly it seems it is becoming one of the most vital and critical Articles in the EU regulations to ensure essential products reach patients in time.
It would be up to member states, the recommendation states, to authorize a partial repeal of the requirements, even when products do not require the involvement of a notified body, i.e. in the case of Class I devices.
Medtech Insight notes that the last time Article 11 (13) came under the spotlight was in April 2018, when there was fear that individual components of joint replacements would no longer be available as CE-marked medical devices under the MDR, because the higher requirements of the MDR would encourage companies to no longer support some of their joint replacements systems.
Medical Device Or PPE?
The recommendation lists which lower risk products fall under the definition of devices and which fall under the definition of PPE, as follows: