EU Medical Device Regulation. MDR 2017 745 EU...

Information & Training. | Medical Devices.

The current EU regulatory framework for medical devices, (excluding in-vitro diagnostic medical devices), consists of Council Directive 90/385/EEC for active implantable medical devices (AIMDD) and Council Directive 93/42/EEC for medical devices (MDD) which cover a huge spectrum of products. These directives have over time been updated and supplemented, the most recent revision being 2007/47/EC, which supplements both the AIMD and the MDD.

The existing regulatory framework has demonstrated its merits but has also come under harsh criticism, in particular after the French health authorities found that a French manufacturer (Poly Implant Prothèse, PIP) had for several years apparently used industrial silicone instead of medical grade silicone for the manufacture of breast implants contrary to the approval issued by the notified body, causing harm to thousands of women around the world.

Triggered by the PIP breast implants scandal, the European Parliament called for a revision to the existing medical directives and associated legal framework to guarantee the safety of medical technology.

The proposal is to amend the current directives as follows:

The existing Medical Devices Directive and the existing Active Implantable Medical Devices Directive will be combined into a new Medical Device Regulation 2017/745/EU.

The IVD Directive will also be revised but will remain as the IVD Directive.

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

The timetable for the proposed changes is as follows:
2012 – The European Commission published its proposals for the two new regulations. The European Parliament completed their examination of the proposed regulations and voted on their proposed amendments. The European Council, which brings together the governments of the 28 Member States of the European Union, equally reviewed the proposals.

2013 / 2014 – The European Parliament and the Council negotiated revisions and updates.

2017 – Agreement reached on the new Medical Device Regulations.

2020 – AIMD/MDD revised regulations, MDR 2017/745/EU come into law in the applicable countries of the EU. Note: Due to Covid-19, the Date of Activation has been delayed for 12 months from 2020, to 2021.

2022 – IVD revised regulations applicable into national laws.

The key proposed regulatory changes will be as follows:

The scope of the medical device regulation within the EU will be broadened, e.g. implants for aesthetic purposes will now be included within scope of medical device regulation, and there will be clarification with respect to regulation of genetic testing. There are additional requirements to ensure improved supervision of the national Competent Bodies and Notified Authorities. Also the national assessment authorities will be given more powers and the co-ordination between surveillance bodies will be improved. The EU medical device database (Eudamed) will provide more information on medical devices available across the EU and more of this information will be made available to the public. There will be extended requirements for traceability of medical device product through the supply chain. The clinical requirements for device approval will be strengthened.

Further details on the regulatory changes due to MDR 2017/745/EU:

Scope:
The scope of the proposed Regulation corresponds to a large extent to the combined scopes of Council Directives 90/385/EEC and 93/42/EEC, i.e. it covers all medical devices other than in vitro diagnostic medical devices. However:

·        the scope is extended to some products currently not covered by the AIMDD/MDD;

·        some products which, in some Member States, are placed on the market as medical devices are excluded from its scope.

The extension of the scope concerns:

·        products manufactured utilizing non-viable human tissues or cells, or their derivatives, that have undergone substantial manipulation (e.g. syringes pre-filled with human collagen), unless they are covered by Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Human tissues and cells, or products derived from human tissues or cells, that are not substantially manipulated and that are regulated by Directive 2004/23/EC are not covered by the proposal;

·        certain implantable or other invasive products without a medical purpose that are similar to medical devices in terms of characteristics and risk profile (e.g. non-corrective contact lenses, implants for aesthetic purposes).

Additional provisions as regards products that are not covered by the Regulation have been included, and concern:

·        products that contain or consist of viable biological substances (e.g. living micro-organisms);

·        food covered by Regulation (EC) No 178/2002. Medical devices are excluded from the scope of Regulation 178/2002 (diagnostic probes or cameras, even when introduced orally, are therefore clearly excluded from the food legislation).

As regards products composed of substances or combinations of substances that are intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by or dispersed in the human body, those products which fall under the definition of a medical device are classified in the highest risk class and should comply with the relevant requirements of Annex I of Directive 2001/83/EC on the Community code relating to medicinal products for human use.

Definitions:
This section has been significantly extended, aligning the definitions in the field of medical devices with well established European and international practice, such as the New Legislative Framework for the Marketing of Products.

Making available of devices, obligations of economic operators, reprocessing, CE marking, free movement: this section contains provisions that are typical for product-related internal market legislation and sets out the obligations of the relevant economic operators (manufacturers, authorized representatives of non-EU manufacturers, importers and distributors). The regulatory instrument of ‘common technical specification’ (CTS), which has proven useful in the context of the IVDD, has been introduced in the broader field of medical devices to allow the Commission to further specify the general safety and performance requirements (laid down in Annex I) and the requirements on clinical evaluation and post-market clinical follow-up (laid down in Annex XIII). The legal obligations on manufacturers are proportionate to the risk class of the devices they produce.

Minimum contents of key documents for the manufacturer to demonstrate compliance with the legal requirements are laid down in Annexes II and III.

The following concepts are also new in the field of medical devices:

·        a requirement has been introduced that within the manufacturer’s organization a ‘qualified person’ should be responsible for regulatory compliance;

·        clear conditions are set for enterprises involved in relabeling and/or repackaging medical devices;

·        patients who are implanted with a device should be given essential information allowing it to be identified and containing any necessary warnings or precautions to be taken;

·        strict rules on the reprocessing of single-use devices.

Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance. This section addresses one of the main shortcomings of the current system: its lack of transparency. It consists of the following requirements:

·        economic operators must be able to identify who supplied them and to whom they have supplied medical devices;

·        manufacturers must fit their devices with a Unique Device Identification (UDI) which allows traceability;

·        manufacturers/authorised representatives and importers must register themselves and the devices they place on the EU market in a central European database;

·        manufacturers of high-risk devices must make publicly available a summary of safety and performance with key elements of the supporting clinical data;

·        further development of the European databank on medical devices (Eudamed), set up by Commission Decision 2010/227/EU, which will contain integrated electronic systems on a European UDI, on registration of devices, relevant economic operators and certificates issued by notified bodies, on clinical investigations, on vigilance and on market surveillance. A large part of the information in Eudamed will become publicly available.

The establishment of a central registration database will also do away with diverging national registration requirements which have emerged over recent years and which have significantly increased compliance costs for economic operators.

Notified Bodies under MDR 2017/745/EU:
The proposal sets out requirements for national authorities responsible for notified bodies. It leaves the ultimate responsibility for designating and monitoring notified bodies, based on stricter and detailed criteria laid down in Annex VI, with the individual Member State. At the same time, the position of notified bodies vis-à-vis manufacturers will be significantly strengthened, including their right and duty to carry out unannounced factory inspections and to conduct physical or laboratory tests on devices. The proposal also requires rotation of the notified body’s personnel involved in the assessment of medical devices at appropriate intervals.

Classification and conformity assessment: the proposal keeps to the well established approach of dividing medical devices into four classes. The classification rules (laid down in Annex VII) have been adapted to technical progress and experience gained from vigilance and market surveillance. The different conformity assessment procedures are laid down in Annexes VIII to X and have been tightened and streamlined.

The proposal also:

·        reinforces the powers and responsibilities of notified bodies;

·        introduces the obligation for notified bodies to notify an expert committee of new applications for conformity assessment of high-risk devices.

Clinical evaluation and clinical investigations under MDR 2017/745/EU:
This section lays down the key obligations of manufacturers as regards the performance of the clinical evaluation needed to demonstrate the safety and performance of their devices. More detailed requirements are set out in Annex XIII which addresses the pre-market clinical evaluation and post-market clinical follow-up that together constitute a continuous process during the life cycle of a medical device.

The process for conducting clinical investigations is further developed, particularly through the concept of ‘sponsor’. Non-commercial clinical investigations that do not pursue a regulatory purpose are not covered by this Regulation. Every clinical investigation must be registered in a publicly accessible electronic system which the Commission will set up.

Vigilance and market surveillance: the proposal introduces an EU portal where manufacturers must report serious incidents and corrective actions they have taken to reduce the risk of recurrence. The information will be automatically forwarded to the national authorities concerned. Where the same or similar incidents have occurred, or where a corrective action has to be taken, in more than one Member State, a coordinating authority will take the direction in coordinating the analysis of the case.

As regards market surveillance, the main objectives of the proposal are to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures.

Governance:
A central role in achieving harmonized interpretation and practice will be assigned to an expert committee (the Medical Device Coordination Group or MDCG).

The proposal mandates the Commission to provide technical, scientific and logistic support to the MDCG. It empowers the Commission to adopt either implementing acts to ensure uniform application of the Regulation or delegated acts to complement the regulatory framework for medical devices over time.

With this proposal, other Union legislation is amended where a link exists with medical devices, including Regulation (EC) No 1223/2009 on cosmetic products and the Food Regulation 178/2002.

The future Regulation replaces and repeals Council Directives 90/385/EEC and 93/42/EEC.

Reference: European Parliament, 2012/0266(COD) – 26/09/2012 Legislative proposal

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>

References:
EU Commission Medical Device Regulations
European Medical Device Regulations