MDR/IVDR: Commission adopts new standardization request
Regulatory News | 16 April 2021 |
The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.
In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to revise some 201 existing harmonized standards and draft 27 new standards over the next three years. The two standardization bodies have one month to indicate whether they will accept the request under Regulation (EU) No 1025/2012 and the Commission has asked CEN and CENELEC to submit a joint work program by 28 May 2021.
The development of harmonized European standards is a major component of the new device and IVD regulations, as products developed in conformity with harmonized standards referenced in the Official Journal of the European Union (OJEU) are presumed to be in conformity with the corresponding legal requirements laid out in the MDR and IVDR.
In its standardization request, the Commission says that the harmonized standards “should include detailed technical specifications in relation to the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, especially with respect to the design and manufacture of devices, risk management and the obligations on economic operators and sponsors, including those relating to quality management systems, risk management, clinical investigations and performance studies, and clinical evaluation and clinical evidence. They should also indicate clearly the correspondence between the technical specifications and the requirements they aim to cover.”
In a guidance on medical device standardization released on Friday, the Medical Device Coordination Group (MDCG) explains that harmonized standards generally allow “manufacturers and other sectorial actors (including notified bodies and national competent authorities) to make easier, quicker and less burdensome the processes related to conformity assessment procedures, affixing of the CE marking and placing on the market, market surveillance, etc.”
In general, the use of harmonized standards is voluntary, though there are some exceptions where the use of harmonized standards is mandatory. For instance, harmonized standards must be followed for symbols and identification colors where such standards are available.
“The voluntary character of the use of standards means that in practice that the manufacturer may always choose to apply the technical solutions provided by the harmonized European standards cited or not cited in the OJEA, or by non-harmonized European standards, or by any other international or national standards, or even to develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonized means are adequate to comply with the legal requirements applicable to the product,” MDCG writes.
MDCG also explains that the Commission’s standardization request will be regularly revised and updated to address new and updated standards at the European and international level.
The remainder of the MDCG guidance provides an overview of the legal basis, development and publication of harmonized European standards and discusses the international aspects of standardization and the concept of “state of the art” as it relates to standards.
European Commission Standardization Mandate, MDCG
In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) to revise some 201 existing harmonized standards and draft 27 new standards over the next three years. The two standardization bodies have one month to indicate whether they will accept the request under Regulation (EU) No 1025/2012 and the Commission has asked CEN and CENELEC to submit a joint work program by 28 May 2021.
The development of harmonized European standards is a major component of the new device and IVD regulations, as products developed in conformity with harmonized standards referenced in the Official Journal of the European Union (OJEU) are presumed to be in conformity with the corresponding legal requirements laid out in the MDR and IVDR.
In its standardization request, the Commission says that the harmonized standards “should include detailed technical specifications in relation to the requirements set out in Regulations (EU) 2017/745 and (EU) 2017/746, especially with respect to the design and manufacture of devices, risk management and the obligations on economic operators and sponsors, including those relating to quality management systems, risk management, clinical investigations and performance studies, and clinical evaluation and clinical evidence. They should also indicate clearly the correspondence between the technical specifications and the requirements they aim to cover.”
In a guidance on medical device standardization released on Friday, the Medical Device Coordination Group (MDCG) explains that harmonized standards generally allow “manufacturers and other sectorial actors (including notified bodies and national competent authorities) to make easier, quicker and less burdensome the processes related to conformity assessment procedures, affixing of the CE marking and placing on the market, market surveillance, etc.”
In general, the use of harmonized standards is voluntary, though there are some exceptions where the use of harmonized standards is mandatory. For instance, harmonized standards must be followed for symbols and identification colors where such standards are available.
“The voluntary character of the use of standards means that in practice that the manufacturer may always choose to apply the technical solutions provided by the harmonized European standards cited or not cited in the OJEA, or by non-harmonized European standards, or by any other international or national standards, or even to develop its own technical solutions, provided that it is able to demonstrate that these different or alternative non-harmonized means are adequate to comply with the legal requirements applicable to the product,” MDCG writes.
MDCG also explains that the Commission’s standardization request will be regularly revised and updated to address new and updated standards at the European and international level.
The remainder of the MDCG guidance provides an overview of the legal basis, development and publication of harmonized European standards and discusses the international aspects of standardization and the concept of “state of the art” as it relates to standards.
European Commission Standardization Mandate, MDCG
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