The Medical Device Regulations – What You Need To Know
Change is the only constant in the life sciences sector and the introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. We have been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients there are many topics that are being raised time and again.
The advent of the new Medical Devices Regulation (MDR 2017/745) in May 2020 is a cause of much concern for manufacturers and others in the devices sector. The new regulations will bring about many changes compared to the current regulatory framework.
Firstly, what is the MDR?
Medical Devices Regulation (MDR)(EU) 2017/745 repeals the existing medical device directives that were first put in place in 1993. The new regulation was published on May 5th, 2017 and will come into force on May 26th, 2020.
Why Are We Moving from MDD to MDR?
The Medical Devices Directive (93/42/EEC) was in force for all members states of the EU (there are currently 28 including the UK), the members of the European Economic Area (Iceland, Lichtenstein and Norway) and two countries with bilateral trade agreements with the EU (Switzerland and Turkey). Directives are transposed into national legislation by each Member State and this meant that the directive was open to interpretation by each participating member state and, as such, it was not uniformly implemented across all participating countries. Furthermore, the 1993 Directive has not kept pace with the seismic changes in medical technology. Regulations are directly applicable in all Member States and do not require transposition into national law. The new regulations have been introduced to enforce uniformity and to address the developments in device capability and technology. The scandals in Europe involving device manufacturers in recent years have also added to the need for a more robust regulation of medical devices.
What Are the Most Important Changes?
The new MDR presents a significant development in device regulation. Some of the main changes affecting manufacturers are highlighted below, but this list is not exhaustive.
1. Product scope expansion to include products that do not have a medical purpose.
2. Enhanced roles of economic operators to include manufacturer, authorised representative, distributor and importer.
3. The issue of liability is much enhanced in the new regulations. EU Authorised Representatives will be held jointly and severally liable for devices.
4. Requirement for manufacturers to appoint a responsible person (RP) who is responsible for compliance with MDR.
5. More rigorous clinical evidence / clinical evaluation requirements.
6. Increased focus on post market surveillance.
7. An overhaul of Eudamed, the European electronic database for medical device information.
8. Introduction of UDI system – Unique Device Identifiers – to enhance traceability
The Increased Role of Clinical Data
Perhaps the most significant change from the MDD to the MDR is the increased focus on clinical evaluation, access to data and post market surveillance. This places a greater burden upon manufacturers and their representatives, and it is something that we, at Acorn Regulatory, are helping our clients with.
The MDR only allows comparison under equivalence with one device. Using the equivalence approach to clinical evaluation will be much more difficult to achieve as manufacturers must have contracted access to the full technical documentation of the product with which they claim equivalence. There is an increased responsibility on manufacturers to document the effectives, safety and quality of their own devices.
What Is A Medical Device?
The scope of Regulation (EU) 2017/245 (MDR) has changed to include a broadening of the range of products that are subject to the new requirements.MDR 2017/245 covers devices that previously fell under two separate European directives, the Medical Devices Directive (MDD 93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC).
Article 1 of MDR 2017/245 indicates which type of devices are required to comply with these new regulations.
Article 2 of the MDR 2017/245 defines the term “medical device” as any “instrument, apparatus, appliance, software, implant, reagent, material or other article” intended to be used for any of the following medical purposes:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease, disability or injury, where prevention of disability and injury is excluded
- Investigation, replacement or modification of an anatomical, physiological or pathological process
- Providing data via in vitro examination of samples derived from a human body
- The MDR also identifies particular types of products that also qualify as medical devices:
- Products intended for cleaning, disinfection and sterilization of medical devices
- Devices for the control and support of conception
Products manufactured utilising nonviable human tissues or cells (and their derivatives) will now also be regulated under MDR.
Annex XVI of MDR 2017/245 lists groups of products that, even though they have no intended medical purpose, are required to meet MDR requirements.
These include devices used for aesthetic and cosmetic purposes, such as coloured contact lens, dermal fillers, equipment used for liposuction etc.
Accessories (which are products that are intended to enable a device to be used in accordance with its intended purpose or to assist the medical functionality of the medical device) are also covered under MDR 2017/245 (similar to the MDD 93/43/EEC).
However, as some products are now added to the definition of a medical device, it is now important to note that their accessories will also now be covered under the scope of the MDR.
Taking all this broadening of scope into account, means that certain devices who were previously not covered under the MDD 93/42/EEC, now fall under the remit of MDR 2017/245.
In particular, there are now manufacturers, who previously were not subject to the requirements of MDD 93/42/EEC who are now subject to MDR 2017/245.
Risk Based Classification
Classification of Medical Devices is based on risk as outlined in Annex VIII of MDR 2017/245.
While the structure of the rules under MDR 2017/245 remain as per MDD93/42/EEC, there are now a number of additional Special Rules under MDR which mean there are now 22 rules in total.
Devices classification range from Low Risk (Class 1) to High Risk (Class III).
Active Implantable Device manufacturers should also note that MDR now covers Active Implantable devices and these are subject to the requirements of Class III devices.
As a manufacturer is it important to consult the regulations directly to determine whether your medical device is covered under the new MDR 2017/245.
Some Questions To Consider
- Are you a device manufacturer that is now covered under the new MDR 2017/245 and are trying to understand what is required under MDR 207/245?
- Or are you a device manufacturer trying to determine whether your device falls under the scope of MDR 2017/245?
- Or are you trying to determine how to classify your medical device under MDR 2017/245?
- Are you aware of your responsibilities under EU MDR? Do you have the resources and systems in place to fulfil your obligations under the new Regulations?
The MDR provides detail on the additional roles responsibilities of various Economic Operators in the medical device supply chain. This was examined in our recent article featured on the Acorn Regulatory website. You can read the brief Economic Operators article by clicking here. In this article we look in more detail at the role of Authorised Representative required for manufacturers based outside of Europe.
It was established in the Directives to act as a contact point within Europe who could act on behalf of the manufacturer. The scope of the role of Authorised Representative has been expanded under MDR compared to previously, and details may be found in Articles 11 and 12 of Regulation (EU) 2017/745.
What Is An Authorised Representative?
The authorised representative is defined as ‘any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations’ under the Regulation.
The existing MEDEV on authorised representatives has essentially been incorporated into the Regulation and there is also an article that describes the process to change an authorised representative.
What’s New? Authorised Representative Obligation under 2017/745
The manufacturer must be based outside of the EU and there is a new requirement for there to be a written mandate to define the designation of authorised representative and for this to be signed and accepted by both manufacturer and authorised representative.
The authorised representative must verify the declaration of conformity, conformity assessment, technical documentation, registration requirements and manufacturer obligations.
keep available a copy of the declaration of conformity, technical documentation and certificates.
establish systems for provision of information to CAs and manufacturers; CAPA; registration; complaint handling; establishment, maintenance, termination of mandate; person responsible for regulatory compliance.
In addition, the Regulation stipulates that the authorised representative is legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations.
The Role of the PRRC under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we consider here the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.
Article 15 of MDR 2017/745 sets out the detail of the person responsible for regulatory compliance. It requires that manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. Similar authorised representatives are required to have permanently and continuously at their disposal at least one person responsible for regulatory compliance. The requisite expertise is also detailed in Article 15 and involves either:
(a) a formal qualification such as a degree in law, medicine, pharmacy, engineering or other relevant scientific discipline and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices or
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices
The five main responsibilities of the person responsible for regulatory compliance are to ensure that:
- The device conforms to the manufacturers quality system prior to release.
- The technical documentation and EU declaration of conformity are properly maintained.
- The post-market surveillance obligations are complied with including post market surveillance plan, post-market report and periodic safety update report as applicable.
- The reporting obligations are fulfilled for serious incidents, field safety corrective actions and trend reporting.
- The statement referred to in Section 4.1 of Chapter II of Annex XV is issued in the case of investigation.
There is a provision within MDR that allows micro and small enterprises to outsource the PRRC role and to have an appropriately qualified person permanently and continuously at their disposal rather than having that person within their organisation. The definition of micro and small enterprises comes from Commission Recommendation 2003/361/EC and relates to number of employees and turnover/balance sheet figures. A small enterprise is defined as an enterprise which employs fewer than 50 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 10 million. A microenterprise is defined as an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million. The outsourced PRRC must then be listed as a critical supplier on the manufacturers quality system and an agreement must be in place between both parties.
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied.
Click the cover image to download the whitepaper.
Acorn Regulatory has published its first medical device regulations (MDR) whitepaper. The whitepaper looks at a range of issues including:
- The responsibilities of the Person Responsible for Regulatory Compliance
- The impact that the new MDR will have on the role of the EU Authorised Representative
and most importantly, the whitepaper will look at what actually constitutes a medical device. The new regulations have widened the definition of what is actually a medical device and this change is bound to have significant impact on manufacturers.
Acorn Regulatory can help you to manage your MDR responsibilities. Our team of medical device experts have a wealth of experience gained in industry and with national health authorities.
If you would like to talk to a member of our expert team, then please complete the webform below or contact us on 00353 52 61 76706.