PPL are proud to confirm that we are fully compliant with the new EU Medical Device Regulation (MDR) 2017/745 which comes into force this Wednesday (26th May 2021).
PPL have navigated the challenges of Covid, and Brexit and we will continue to maintain our reliable supply chain as MDR now comes into force. MDR is complex and Brexit has led to further complications for the entwined medical device markets in Ireland and the UK.
PPL have been working hard to be ready for MDR D-Day and are thrilled we can say we have full compliance. We have been preparing since 2019 for the MDR changes. PPL have invested heavily in 2020/21 in our internal ISO 13485 compliant Quality Management System, People, and training on ISO 14971:2019 Application of risk management to medical devices.
Naturally, an increase in regulation leads to improvements for everyone in the supply chain, and therefore improvements in patient care. PPL are really excited to be part of this new chapter for medical devices.
We hope this information on PPL and MDR will enhance your understanding of the implications for Healthcare Professionals and their suppliers.
What is the MDR?
The EU 2017 Medical Device Regulation (MDR) replaces several Medical Device Directives which have been around since 1990. The new MDR brings about increased regulatory burden for manufacturers, importers, and distributers of Stock (Mass Produced) medical devices and includes changes for Custom-Made device manufacturers.
What is the purpose of MDR?
The purpose of MDR is to protect Patient Care/Clinical outcome in the EU. Patient care and clinical outcomes both directly related to the “safety of” and “safe use of” medical devices.
What is a Medical Device?
A medical device is a product that has a role in the diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. The MDR applies to all medical devices [ranging from Class I (low risk devices) to Class III (high risk devices)].
What Medical Devices do PPL Manufacture and/or distribute?
PPL only manufacture and supply Class 1 (low risk devices), namely:
- Custom-made Devices e., Prescription Insoles
- Adaptable Mass Produced Devices e., Vasyli Custom
- Mass Produced (Non-Adaptable) Devices e., Feet in Motion
- Intermediate Products/Accessories e., Heel Raises
PPL’s Custom-made devices are all “truly custom” and manufactured based on a prescription. PPL do not manufacture or distribute patient-matched devices, which are generally found in the retail sector. MDR applies to patient-matched devices also.
Who is responsible for compliance with MDR?
The medical device manufacturer, importer, and distributer are responsible for MDR compliance. A compliant (i.e., Safe and Performing as Intended) medical device must have appropriate labelling, packaging and Instructions for Use available and a product recall/traceability system must be in place.
Typically, the healthcare professional (person authorised by law in each EU state) is responsible for the prescription/selection, fitting and use of the MDR compliant medical device.
HPRA (Health Products Regulatory Authority) is the Irish Competent Authority (CA) who is responsible for regulating the medical device market in Ireland. Manufacturers, Importers and Distributors who are placing products anywhere on the EU market must register with their local CA (such as HPRA for Irish entities). Manufacturers and Importers must register on Eudamed (the EU medical device database). PPL has completed its registration with the HPRA and is registered on Eudamed.
What Changes is MDR Making for PPL’s Customers?
You will have seen and will continue to see some changes in the labelling and Instructions for Use of the medical devices that PPL manufacture and distribute. Any imported devices shall include PPL’s name and address as the official EU Importer of the product.
What Changes is the MDR Making for Manufacturers, Importers and Distributers?
The MDR is a lot more comprehensive than the previous Directives (known as MDD). Where the old MDD had 23 articles, the MDR has a hefty 123, and comes in at nearly three times as many pages. While nothing from the old MDD has been lost, a lot has been added, including:
- A unique device identification system for Stock Devices, enhancing traceability within the supply chain.
- Changes in the risk category of certain product types
- More stringent requirements for clinical evaluations and investigations
- Upgraded requirements for post-market surveillance
What do PPL’s customers need to do?
To prescribe a Custom-made Device you need to continue to follow PPL’s previous protocols.
That being; provide PPL with a written (any form) prescription for an individual patient. The prescription needs to contain the unique design specifications, PPL can support design queries, but the customer is responsible for medical device design and specifications.
Do I have to register with anyone to prescribe medical devices?
You do not need to register with local Competent Authorities such as the HPRA unless you are a Manufacturer, Importer or Distributor of medical devices on the EU market after 26th May 2021.
You do not need to register with local Competent Authorities such as the HPRA if you are adapting a medical device or applying an accessory to it (such as a Heel Raise), so long as you do so in compliance with the Manufacturer’s Instructions for Use which are provided with the EU MDR compliant medical device and the adaptation or accessory applied does not alter the devices intended purpose. [Refer to EU MDR Article 16 for more information]
PPL cannot offer any advice regarding who is and is not authorised to prescribe medical devices. This is a question for local Competent Authorities such as the HPRA to answer. MDR explicitly states that the person prescribing custom-made medical devices should be “a person authorised by national law”. The EU clarifies this is up to each Member State to establish what qualifications are required and typically in the EU this is a healthcare professional. [Refer to EU MDR Article 2 for more information]
What if I am buying Medical Devices from outside the EU?
Non-EU Manufacturers and Importers of medical devices into the EU market, must be registered in Eudamed and must comply with the applicable
The UK is implementing its own medical device regulatory system. This will be enabled through the powers created through the Medicines and Medical Devices Bill. The UK Competent Authority is MHRA (Medicines and Healthcare Products Regulatory Agency) and is responsible for regulating the UK medical devices market. To place medical devices on the UK market a UK Responsible Person must be established, and the devices must be registered with MHRA.
The Northern Ireland protocol (known as Article 16) allows Northern Ireland to retain full access to the single market i.e. remains within the European Economic Area (EEA) and thus EU MDR compliance is required for medical devices distributed within this location.
What Changes will I see regarding Stock “Off-the Shelf” Medical Devices?
PPL distribute Stock “Off-the-Shelf” devices. The device manufacturer (and not PPL) is responsible for ensuring that their products are MDR compliant. PPL has been working with its suppliers of Stock “Off-the-Shelf” devices to ensure that the required updates to meet EU MDR requirements have been actioned.
PPL will continue to distribute MDD compliant Stock “Off-the-Shelf” devices (where devices were receipted into the PPL warehouse before Wednesday 26th May 2021). There is a period of adaption, in which customers will see the product labelling and Instructions of Use changing from the previous MDD requirements to the new MDR Compliance requirements.
PPL only distribute quality brands and medical devices from reputable partners. We have been working with all our suppliers since 2019 to ensure that PPL can continue to supply the brands and products our customers want to prescribe.
Will MDR compliance be enforced?
Yes – MDR compliance will be enforced by local Competent Authorities such as the HPRA. HPRA will use a risk-based approach to verify compliance of manufacturers, importers, and distributors of medical devices over the coming months and years. Notified Bodies such as NSAI, BSI, DEKRA and TUV are also responsible for ensuring adherence to the regulation during their annual client audits and certification of client Quality Management Systems.