The tidal wave of Covid-19 that has hit the world since the beginning of this year has created an unprecedented demand for personal protective equipment (PPE) products, as well as for medical devices (MD) on the European and world markets, alike. The demand has not just been extremely high, but it has also risen to such levels over a very short period. This has created complexities of all sorts for the supply side. Established operators in these sectors reacted swiftly to increase their output, and new market entrants adapted from their prior operations to contribute to the same ends.
This influx of PPE and MD onto the European market has been accompanied by an increase in products that are either counterfeit themselves, and/or accompanied by invalid, or even falsified, documents when it comes to their conformity.
If you are interested in selling, buying or using PPE or MD, yet you are unfamiliar with the regulated sectors of PPE and MD in the EU, then this article is for you. In what follows we will be basing ourselves on the European Commission guidelines and:
- Set out the applicable regulatory frameworks for PPE and MD;
- Outline the conformity assessment procedures and the resultant documentation required for placing these products on the EU market, lawfully;
- Emphasize the main characteristics of valid documentation for this purpose;
- Clarify which documents are frequently mistaken for the valid documentation and why they cannot replace it;
- Delineate the exceptional circumstances in which the above can be foregone in the context of the Covid-19 pandemic.
1. Applicable regulatory frameworks
Medical Devices are currently regulated by three complementary Directives, while Personal Protective Equipment is regulated by a single, all-encompassing, Regulation. More specifically:
- Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to Active Implantable Devices (AIMDD); Council Directive 93/42/EEC concerning medical devices (MDD); Directive 98/79/EC of the European Parliament on in vitro diagnostic medical devices.
- Regulation (EU) 2016/425 of the European Parliament and of the Council on personal protective equipment and repealing Council Directive 89/686/EEC (PPER).
The Medical Device sector will soon see a regulatory overhaul, as the Directives are being repealed and replaced by two Regulations. These Regulations came into force in May 2017 and, while they will not be fully applicable until May 26, 2021 and 2022, respectively, they may be used for placing medical devices on the EU market at this time.
2. Conformity procedures and documentation
In order for MD and PPE to be lawfully placed on the EU market, first they must be CE marked with the EC (or EU) Declaration of Conformity (DoC). This document is to be issued and signed by the manufacturer, declaring that their products comply with the applicable EU legislation and requirements.
In support of the DoC, the manufacturer must also prepare and maintain the relevant technical documentation for the product/device. This documentation must be kept and made available to national competent authorities upon their request.
For certain classes of MD and categories of PPE, the manufacturer is required to involve a Notified Body (NB) in the prescribed conformity assessment procedure(s). The role of the NB is to assess the compliance of the product/device with the applicable requirements of the EU legislation. Upon completing a successful assessment, the NB will issue a certificate. Depending on the type of product/device, this certificate will be known as CE certificate, EU type-examination certificate or design examination certificate. The CE mark of such products must also bear the four-digit identification code of the NB next to the CE mark.
MD manufacturers from outside the EU must designate a single European Authorized Representative (EAR/EC REP) in the EU. One of the EAR’s roles is keeping the relevant technical documentation and making it available to national competent authorities within the EU. The EAR’s information, alongside the manufacturer’s information, must be found on the DoC, on the NB certificate (where applicable) and on the labelling of the device.
Just as the main pieces of EU legislation are not prescriptive about the technical solutions to-be-used in the conformity assessment, so too the PPE and MD legislation are “technologically neutral”. In other words, the legislations lay out a desired outcome in terms of which essential requirements are to be met, but do not prescribe a mandatory method for how the manufacturer can meet them. The manufacturer can use an existing standard or develop his/her own technical solutions.
III. Characteristics of valid DoCs and Certificates
Now that we have outlined some conformity assessment procedures and the resultant documentation to prove such conformity, we will look closely at what this documentation must include, in order to be valid.
A valid DoC must include the following elements, amongst others (non-exhaustive list):
- Identification/description of the product; EU legislative acts to which conformity is claimed; The name and registered address of the manufacturer and that of the EAR for non-EU manufacturers; A statement to the effect that the Declaration is issued under the sole responsibility of the manufacturer; The conformity assessment procedures applied….
If a product falls under the scope of two or more EU legislative acts, then, it must comply with all the applicable provisions in order to be CE marked. To this effect, a single DoC will have to be drafted declaring conformity with all the applicable legislative acts and their requirements. This “overlap” is particularly relevant for PPE/MD in the Covid-19 context where certain products are “double purpose” depending on who uses them and where.
In order for a certificate to be valid, the NB issuing it must be listed on the European Commission’s NANDO information system. Moreover, the NB has to be listed on NANDO under the specific legislative acts for which it has been given the competence to issue certificates. Not all NBs can issue valid certificates under every legislative act/for every type of product. Therefore, in those cases where a product falls within the scope of two or more legislative acts, one or more NBs might have to be involved in the conformity assessment, depending on their competences.
Each certificate issued by a NB prior to a MD or PPE being placed on the market must include, amongst others (non-exhaustive list):
- Conformity assessment procedure applied; references to test reports and harmonized standards (if applicable); the full name and four-digit identification number of the NB.
4. Documents which are not valid for the purposes of placing a product on the EU market
Other documents, such as “certificate of compliance”, “attestation of compliance”, “certificate of conformity”, “certificate of notification”, “certificate of registration”, “documentation review” or similar are not valid for the purpose of placing devices on the market. These “other” documents can sometimes be issued by a NB, but that alone does not make them sufficient for placing products on the European market. They can also be issued by other entities such as non-notified/certification bodies, testing houses, laboratories and EARs.
Likewise, “test reports”, issued by NBs or other testing entities, after assessing products in accordance with a standard, are not valid documents for the purpose of placing products on the EU market. This applies even if they are issued in relation to European harmonized standards with a presumption of conformity. Other manufacturer-issued documents, such as risk assessment logs, are not valid for placing products on the market either. These are documents which, where applicable, must be submitted to the NB for the performance of the conformity assessment procedure, which, in turn, may result in a valid certificate.
While these documents are not valid for the purpose of placing products on the market, they may be included in the technical documentation as supporting documents or evidence of compliance with certain requirements.
5. Exceptions for placing products on the market in the context of the Covid-19 pandemic
The medical devices directives and regulations include a provision known as the “national derogation”. This empowers national competent authorities, on a duly justified request and in exceptional circumstances, to authorize the placing of devices on their respective national markets for which the relevant conformity assessment procedures have not been fully carried out. This derogation can be activated where the availability and use of these devices is in the interests of: protection of health, public health or patient safety/health.
The PPE Regulation, by contrast, does not include such a standard provision. In the context of the Covid-19 pandemic, however, the European Commission has issued a Recommendation that allows for some degree of flexibility with a view to improving the availability of PPE and MD devices. These exceptions are subject to strict conditions and only for devices/products destined to be used exclusively by healthcare workers. National competent authorities may therefore authorize the “making available” of some products on their national markets, for a limited period of time and for specific recipients, even if the necessary conformity procedures are still being carried out.
To find out more about the requirements of the PPE Regulation, the Medical Devices Regulations and how to transition to them from the requirements of the Directives, please contact one of our experts here.