On 23 July 2020, the MHRA published a news story warning about largely meaningless “certificates of compliance” or “Attestations of Compliance” issued by certification bodies in relation to Class I medical devices. These certificates tend to state that the issuer has:
- reviewed the technical documentation for the Class I medical device, or
- confirmed that the device concerned meets the requirements of the Medical Devices Directive.
Medical devices are currently regulated under the Medical Devices Directive (MDD) and the UK Medical Device Regulations 2002 (although this will change in May 2021 as detailed in this previous On The Pulse article). Medical devices are classified as Class I, IIa, IIb, or III (in order of increasing risk). While Class I medical devices have the lowest risk profile, there are still a number of regulatory hurdles that must be cleared in order to put them on the market.
We have recently seen some of these certificates in respect of in vitro diagnostics (which are regulated under a different but similar framework). This is not entirely surprising in light of the recent uptick in enthusiasm for the COVID-19 testing market.
Regulatory requirements for Class I medical devices
Medical devices in classes IIa and above require certificates from an independent Notified Body (we have written about the current challenges with Notified Bodies previously here). Class I medical devices that are supplied sterile or have a measuring function must also obtain a certificate from a Notified Body.
The manufacturer of a Class I medical device does not require the involvement of a Notified Body and must issue its own declaration of conformity confirming that its device complies with the MDD.
Certificates of compliance and Attestations of Conformity
What then is the point of a separate “certificate of compliance” or “Attestation of Conformity”? There is no legislative requirement for any such document, nor is it necessary. The MHRA very clearly states in their news story that “certificates of compliance or Attestation of Conformity documents have no legal standing under the UK Medical Device Regulations 2002” (emphasis added).
The bodies awarding these documents may well undertake a review of the technical documentation and/or the product. However, the conclusion they draw has no legal effect.
The certificate of compliance issued really has no greater legal significance than you or I giving a supermarket a piece of paper which states that, having inspected and eaten their produce, it is indeed edible.
The MHRA gives these documents short shrift in their news story highlighting that “[t]hese certificates are not evidence that the manufacturer has met the regulatory requirements, and should not be taken as proof of such”.
As these “certificates” have no real legal standing in the UK and offer no value in demonstrating compliance with regulatory requirements, distributors, importers, end users and purchasers of Class I medical devices should not rely on any such certificate when making decisions about the compliance of such a device with the regulatory regime. This is good reminder of the importance of a due diligence by specialists. A potential acquirer of a medical devices business will want to undertake an independent regulatory due diligence on the relevant product range. The provision of certificates such as this might give an acquirer a false sense of security, but should not encourage the acquirer to undertake “light-touch” regulatory diligence. Further, certificates such as this are not a valid justification for the seller to resist customary contractual protections in favour of the acquirer (e.g. warranties or, where applicable, indemnities that the business and products comply with applicable laws) in the deal documentation.