white paper

IVDR Regulation for EU

These upcoming changes to the MDD aim to overcome the flaws and gaps of the existing regulatory framework to sell medical devices in Europe, which has been in place for 20 years. Once adopted by the European Parliament and the Council on Medical Devices, the new legislation will be in the form of directly enforceable regulations in Member States—in contrast to the current regime, which is based on Directives. Our white paper can help you understand these new regulations.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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IVDR Regulation for EU

IVDR meaning and IVD Regulation

Reasoning for IVDR Regulation

Previously, the MDD regulation and framework for the medical device industry had been in place for over 20 years. It came under harsh criticism in the media and political arena in particular after findings of the French health authorities. A French manufacturer (Poly Implant Protese, PIP) used industrial silicone instead of medical grade silicone for manufacture of breast implants over several years.


IVDR Performance Evaluation

The primary driver of IVDR regulation is several weaknesses that have undermined the objectives of the three medical device directives. Further, medical device companies and medical device safety in general has become more important globally.

Free circulation within the internal market was identified in public consultation held by Commission in 2008, and again in 2010. In addition, the new IVDR regulations aims at overcoming these gaps while maintaining the objectives of the legal framework.

MDD Issues

Regulated companies previously worked with over 70 designated notified body members under the three medical device directives. Simultaneously, the Notified Body Operations Group (NBOG) was designed to improve the overall performance of notified bodies in the medical devices sector. 

Oversight of Notified Bodies

Authorities and medical device manufacturers reported significant differences in the designation and monitoring of the notified bodies. For instance, the quality and depth of the conformity assessment came under intense scrutiny.

Factory Acceptance Inspection

Unannounced factory inspections or product checks led to an uneven level of protection of patients and users. Accordingly, there were noticeable differences between how global regulatory agencies and notified bodies reviewed manufacturers of similar products.


Post-Market Safety

Experience with application of the vigilance system and other legal instruments available to Member States (e.g., safeguard clauses) also came under scrutiny.

As a result, industry reports demonstrated that national competent authorities did not have the necessary global market research for decision making. information available to react similarly to the same problems.  which begs the question of a harmonized level of protection.


No exact data exist as regards the medical devices placed on the European market. Several Member States have set up their own electronic tools, and multiple registration requirements in individual member states. This places an administrative burden on manufacturers and authorized representatives to market a product in different Member States.


Some have started imposing traceability requirements on economic operators. However, the national systems are not compatible with each other and do not allow traceability across borders which is necessary for an EU-wide high level of patient safety.

External Expertise

External experts are currently not involved in the regulatory process in a structured way.


EU Regulatory System

The management of the regulatory system at EU level has shown weakness which have been reported by various interested parties; it is considered as not sufficiently efficient and effective.

There is no legal basis in the medical devices directives to ensure an overview of the situation at EU level and appropriate coordination between Member States.

Technical Support

There is a lack of technical, scientific, and logistic support leading to a lack of uniform application of the rules and of common reactions in European market. The demarcation between the medical device directives and other regulatory frameworks is not always clear which leads to the application of different legal regimes.

Obligations of economic operators are currently not clear or covered by the directives at all.

Specific Issues

Regulatory gaps exist with regard to certain products. For example, products manufactured utilizing nonviable human tissues or cells, implantable or other invasive products without a medical purpose. Also, the reprocessing of single-use devices is not regulated by EU legislation.

IVD’s “in-house” tests are currently exempt from the IVDR regulation.


IVD classification

Another important issue, classification of  IVD’s: current approach for IVD classification is different from the classification approach taken from other medical devices and IVDR regulation.

Requirements of the IVDR regulation, needs to be adapted to technological, scientific, or regulatory developments.

Risk Classification

For medical devices, some legal provisions, such as essential requirements and criteria for risk classification of devices, do not sufficiently reflect the technological and scientific developments.

EU legislation currently does not make provision for any coordination between Member States. Further, the assessment of applications for clinical investigations is still individually conducted in more than one Member State.

Clinical Investigations

Moreover, this revision provides the opportunity to align the provisions regarding clinical investigations on medical devices, where appropriate, with the recently adopted Proposal for a Regulation on clinical trials on medicinal products for human use.


Proposed Revision

The current medical device directives are based on the treaty provisions regarding the establishment and functioning of the internal market (Article 114 TFEU). The Libson Treaty has added a legal basis in the area of public health for the adoption measures setting high standards of quality and safety of medical products (Article 168(4)(c) TFEU).

The proposed revision of the existing directives will integrate the modification of the Libson Treaty, to improve the level of protection of public health for all European parties and users.

Harmonized rules and procedures will allow manufacturers and Subject Matter Experts (SMEs) to reduce costs related to national regulatory differences, while ensuring a high and equal level of safety.

Moreover, this revision provides the opportunity to align the provisions regarding clinical investigations on medical devices. Where appropriate, this supports the adopted Proposal for a Regulation on clinical trials on medicinal products for human use.


IVDR regulation

The IVDR regulation revision pursues three overall objectives:

  1. To ensure a high level of protection of human health and safety
  2. To ensure the smooth functioning of the internal market
  3. To provide a regulatory framework which is supportive for innovation and the competitiveness of the European Medical device industry

In addition, several specific objectives related to individual problems identified.

IVDR regulation


The new legislation will be in the form of regulations – which are directly enforceable in Member States – in contrast to the current regime, which is based on Directives.The following table indicates the preferred policy options in the field of medical devices:


IVDR regulation


The following tables indicate the preferred policy for in vitro diagnostic devices:


IVDR regulation


Summary of IVDR Regulation Revision

The regulation proposal has been ratified by the European Parliament and council. The major difference is that the new legislation will be in the form of regulations. Additionally, these are directly enforceable in Member States—in contrast to the current state based on Directives.

The new regulations cover a wide range of products for the assessment of medical interventions. As it currently stands, the new regulatory environment will include the following:

  • Greater transparency for patients—in particular those taking part in clinical trials.
  • Manufacturers and importers now register themselves and devices on the EU market in a central databaseknown as EUDAMED — the European databank on medical devices.
  • Manufacturers of medical devices will have to fit their products with a unique device identification to ensure traceability.
  • Reinforced rules governing clinical evaluation throughout the life of the device.
  • Introduction of the ‘sponsor’. This new requirement for medical device manufacturers means a single ‘qualified person’ is responsible for regulatory compliance.
  • New rules for the reprocessing of single-use medical devices to make them suitable for further use.
  • An EU portal where manufacturers would report serious incidents and corrective actions taken to reduce the risk of recurrence.
  • A post-market surveillance system detailing device manufacturers’ responsibilities for follow-up of the quality, performance and safety of devices. This includes annual periodic safety update reports (PSURs).
  • A tightening of the rules for the designation of notified bodies. To illustrate, the monitoring of assessment activities by national competent authorities and cooperation between competent authorities. The new rules would also give notified bodies the right to carry out spot checks of unannounced factory inspections.
  • Extension of the scope of medical device regulation to cosmetic / aesthetic devices as well as ‘ingested products’.
  • The introduction of a new expert group: the Medical Device Coordination Group (MDCG). This group has the power to review Notified Body assessments of high-risk devices before approved for market.


About RCA

Regulatory Compliance Associates® (RCA) provides FDA inspection consulting services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021


About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.


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European Union (2012), Executive Summary of the Impact Assessment on the Revision of, the Regulatory Framework for Medical Devices. SWD(2012) 274 Final. Brussels. Resource.

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