Today (26 May 2021) marks an important day for everyone dealing with medical devices: The new Medical Devices Regulation (EU) 2017/745 (MDR) finally comes into effect across the European Union. Enacted in 2017 already to address widespread criticism concerning the safety of medical devices and lack of oversight over medical device manufacturers, delayed by one year due to the COVID-19 health crisis, the MDR now is fully applicable. And, as an EU regulation, it does not need to be transposed into national law. It will be followed in time by the In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR), scheduled to come into force next year, on 26 May 2022.
The MDR replaces existing directives (the Medical Devices Directive - MDD, and the Active Implantable Medical Devices Directive - AIMDD), provides more legal certainty and sets higher standards of quality and safety for medical devices. In doing so it defines obligations not only for manufacturers, but also for their EU-representatives (so called “Authorized Representatives”), distributors and EU-importers.
What does the MDR mean for your products?
Medical devices placed on the EU market must now comply with the MDR. Since compliance assessments under the previous MDD do not carry over, this means in essence that new declarations of conformity (with MDR requirements) must be issued by the manufacturer and a CE marking affixed to each product. Depending on the risk class of the medical device (there are four), a third-party auditor, the so called “Notified Body”, needs to be involved. Given recent notorious capacity constraints of Notified Bodies (only 20 are currently accredited, down from 52 under the previous MDD), there is still a long backlog of medical devices pending MDR assessment.
Luckily, medical devices holding valid conformity assessments above class I under the previous MDD and medical devices holding valid conformity assessments of class I under the previous MDD for which the MDR now requires the involvement of a Notified Body have been grandfathered and may continue to be placed on the market. This may be done until the declaration of conformity expires or until May 2024 at the latest. However, this comes at a price: Grandfathered MDD products may no longer be altered significantly, otherwise they lose their grandfathered status. This includes changing the intended use of a medical device but also its legal manufacturer. The former limits the commercialization of products until they are MDR certified. The latter complicates transactions in the medical devices sector, often requiring comprehensive contractual workarounds to ensure the continued marketability of products.
What does the MDR mean for you as manufacturer?
The MDR expands on the already existing MDD framework, so key requirements should not be completely new to manufacturers of medical devices:
- Certain medical devices (notably: substances and software) will now be placed in higher risk classes, potentially requiring a conformity assessment by a Notified Body for the first time.
- The previous 14 essential requirements set out in the MDD are extended and replaced by 23 general safety and performance requirements.
- Manufacturers must now also formally appoint a person responsible for regulatory compliance.
- Conformity assessment for most devices class II and above now requires specific clinical data as opposed to general clinical literature.
- Manufacturers are required to report key data on their products to EUDAMED, the European database on medical devices. That is, once EUDAMED becomes operational.
- A unique device identifier (UDI) will need to be affixed to each medical device and there are increased requirements concerning the content on labels, promotional materials and the availability of information in different languages of the EU.
- Post-market surveillance requirements and clinical follow-ups have become more stringent and wider under the MDR.
What does the MDR mean for you as EU importer / distributor?
Unlike the MDD, the MDR imposes for the first time specific obligations on EU importers and distributors:
- EU importers may only place MDR compliant medical devices on the EU market. With the actual manufacturer being located outside of the EU, it is essentially the responsibility of the EU importer to ensure that (i) the medical device has been CE marked and that a declaration of conformity has been drawn up, (ii) the manufacturer is identified on the packaging and that – where necessary - an Authorised Representative for regulatory purposes has been designated, (iii) the medical device is correctly labelled and accompanied by the required instructions for use, and (iv) where applicable, a UDI has been assigned. In addition, EU importers have to keep a register of complaints, of non-conforming devices and of recalls and withdrawals. EU Importers are also required to cooperate with manufacturers and competent authorities to mitigate potential hazards caused by medical devices placed on the EU market.
- Distributors now need to meet similar requirements. In particular, distributors have to verify, that (i) the medical device has been properly CE marked and that a declaration of conformity has been drawn up, (ii) the medical device is properly labelled, and (iii) where applicable, a UDI has been assigned. Further, distributors also have to set up a complaint management system, make this information available and have certain information and cooperation obligations towards the manufacturer and competent authorities.
In practice this means that EU importers and distributors may need to expand additional resources to meet these new regulatory requirements. EU importers and distributors should also review existing customer agreements to ensure regulatory responsibilities and risks of non-compliances are clearly distributed.
And what about Brexit?
Brexit doesn’t make the situation easier, and it´s even a bit more complicated when it comes to the situation in Northern Ireland. Since 1 January 2021, the UK is no longer an EU member state and the MDR does not apply in the UK. And despite the EU-UK Trade and Cooperation Agreement in place, companies located in the UK are considered third country manufacturers from an EU medical device perspective. In a nutshell, this means:
- UK manufacturers placing medical devices on the UK market: For now, the Medicines and Healthcare products Regulatory Agency UK (MHRA) allows medical devices to be placed on the UK market as long as they have been CE marked and fully conform with MDD, AIMDD or MDR requirements up until 30 June 2023. From 1 July 2023, new devices placed on the Great Britain market will need to conform with the UK Conformity Assessed (UKCA) marking requirements.
- UK manufacturers exporting medical devices to the EU: UK manufactured medical devices need to comply with the MDR when placed on the EU market, the UKCA (if already applicable) has not been recognized as valid equivalent. As a third country manufacturer, UK manufacturers will need to designate an Authorised Representative based within the EU (or Northern Ireland), who will act as responsible person for regulatory purposes under the MDR and assumes responsibility for the MDR compliance of the products.
- EU manufacturers exporting medical devices to the UK: The UK continues to accept EU manufactured medical devices that comply with the MDD, AIMDD or MDR until 30 June 2023. However, all medical devices must, with certain grace periods, be registered with the MHRA before being placed on the UK market. From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements. In addition, EU based manufacturers also need to appoint a UK Responsible Person for regulatory matters.
What should I be thinking about next?
- Manufacturers of medical devices should confirm their MDR readiness and confirm the work that still needs to be done. If medical devices are currently grandfathered under MDD, any more substantial changes to the devices and the way they are manufactured should be carefully considered.
- Importers and distributors of medical devices need to familiarize themselves with their new obligations under the MDR and determine whether they need to expand additional resources to meet these requirements. Contracts with customers and suppliers should be reviewed to make sure regulatory responsibilities are clearly distributed.
- Financial sponsors considering an investment in a medical device manufacturer should carefully assess the manufacturer’s MDR readiness, the impact of the MDR on the marketability of products, whether grandfathered MDD products can be commercialized as planned and what the envisaged transaction may mean for these grandfathered products.