Bernard Tremaine, Owner, MDRS UK02.22.16
This represents the first in a series of articles that will explore the differences and similarities between the domestic (FDA) and European Union (CE Mark) requirements for placing medical devices into the European Market. Questions addressed will include;
In general, the data compiled in support of an FDA market clearance strategy will, in itself, be sufficient to comply with most requirements for Europe. However, the manner in which data is presented is important and it is this aspect upon which this and subsequent articles will focus.
Please note this first article is more of a general synopsis/introduction. Subsequent articles will cover specific issues in more detail.
Labeling
Labeling (which includes the label, instructions for use, and any other user documentation) is an area fraught with potential pitfalls. There is a generic requirement applicable to all EU countries and this requirement is mandated in the Directive and Harmonised Standards. There are then additional requirements for language translations. Most countries require Instructions For Use to be in their national language, and there are some countries (for example, Belgium and Switzerland) that require multiple language translations. There are some exceptions where English is acceptable, but these often need a dispensation from the Competent Authority along with a risk assessment to ensure that the none-use of the national language does not present any risks to the patient. So a labeling plan is essential to ensure that all the above multiple requirements are adequately addressed.
Clinical Data
Clinical data is the single most common area where manufacturers fail to meet the EU requirements. Usually the clinical data documentation presented to the notified body as part of the assessment process is a huge pile of data covering substantial equivalence information, data from trials and evaluations, and other associated supporting clinical evidence. The main objective of the EU process is to demonstrate the safety and efficacy of the product in question and part of the process is to assess the value and relevance of each of the data in meeting this objective. All this must be prepared in accordance with the EU MEDDEV on Clinical Data and the end result is a CER (clinical evaluation report). The process for creating a CER will be reviewed in a future article.
Post Market Feedback
Post market feedback—sometimes referred to as post market surveillance—is a documented feedback process that is used to confirm the safety and efficacy of the product during the product’s post sales phase. The process must include both proactive and reactive elements and must feed into the risk management, design control, and clinical data elements in order to confirm clinical objectives, and affect product improvement or implement any design changes that might be identified.
Essential Requirements
The essential requirements (ER) are the central focus of an EU compliance strategy. The ERs cover everything from raw materials, biocompatibility, clinical data, design, safety, performance, electrical safety, emissions, risk, manufacturing, post sales, and labeling; all performance aspects are included including a product’s intended purpose and indications and contraindications to use. A manufacturer’s EU compliance documentation would normally be in the form of a technical file or design dossier (depending upon the Class of the product) and an ER checklist (ERC) would be a mandatory requirement. The ERC is presented in the form of a matrix/checklist, where the ERs are listed in one column and the document reference of the compliance data can be easily read off in an adjacent column.
Standards Applied
A section of the technical file must identify and list all the standards, specifications, and reference/guidance documents that apply to the product in question. It must be stated whether the listed documents have been applied in full or part, together with a justification if any standard or document listed has not been applied in full.
Design Verification Data
Design verification data, and in particular, if the product is electrical in nature, electrical safety and electromagnetic compatibility (EMC) compliance certificates must demonstrate that the latest versions of all applicable and necessary standards have been applied. Full validation of any software must also be provided.
Check back for follow-ups to this introduction piece for further insights into what critical information you need to have a product able to be released in both the U.S. and in the EU.
Bernard Tremaine is the former CEO of MDQAS Ltd. (1994 to August 2015). He has 40+ years experience in the healthcare industry, with half of this time being spent at MEI in Milwaukee, Wis, where Bernard held various positions in MEI’s European operations.
- Is my 510(k) PMN data acceptable for Europe?
- Are there additional requirements that I need to be aware of in any of the 31+ countries of the EU?
- Is my clinical data sufficient?
- Do my post market processes meet EU requirements?
In general, the data compiled in support of an FDA market clearance strategy will, in itself, be sufficient to comply with most requirements for Europe. However, the manner in which data is presented is important and it is this aspect upon which this and subsequent articles will focus.
Please note this first article is more of a general synopsis/introduction. Subsequent articles will cover specific issues in more detail.
Labeling
Labeling (which includes the label, instructions for use, and any other user documentation) is an area fraught with potential pitfalls. There is a generic requirement applicable to all EU countries and this requirement is mandated in the Directive and Harmonised Standards. There are then additional requirements for language translations. Most countries require Instructions For Use to be in their national language, and there are some countries (for example, Belgium and Switzerland) that require multiple language translations. There are some exceptions where English is acceptable, but these often need a dispensation from the Competent Authority along with a risk assessment to ensure that the none-use of the national language does not present any risks to the patient. So a labeling plan is essential to ensure that all the above multiple requirements are adequately addressed.
Clinical Data
Clinical data is the single most common area where manufacturers fail to meet the EU requirements. Usually the clinical data documentation presented to the notified body as part of the assessment process is a huge pile of data covering substantial equivalence information, data from trials and evaluations, and other associated supporting clinical evidence. The main objective of the EU process is to demonstrate the safety and efficacy of the product in question and part of the process is to assess the value and relevance of each of the data in meeting this objective. All this must be prepared in accordance with the EU MEDDEV on Clinical Data and the end result is a CER (clinical evaluation report). The process for creating a CER will be reviewed in a future article.
Post Market Feedback
Post market feedback—sometimes referred to as post market surveillance—is a documented feedback process that is used to confirm the safety and efficacy of the product during the product’s post sales phase. The process must include both proactive and reactive elements and must feed into the risk management, design control, and clinical data elements in order to confirm clinical objectives, and affect product improvement or implement any design changes that might be identified.
Essential Requirements
The essential requirements (ER) are the central focus of an EU compliance strategy. The ERs cover everything from raw materials, biocompatibility, clinical data, design, safety, performance, electrical safety, emissions, risk, manufacturing, post sales, and labeling; all performance aspects are included including a product’s intended purpose and indications and contraindications to use. A manufacturer’s EU compliance documentation would normally be in the form of a technical file or design dossier (depending upon the Class of the product) and an ER checklist (ERC) would be a mandatory requirement. The ERC is presented in the form of a matrix/checklist, where the ERs are listed in one column and the document reference of the compliance data can be easily read off in an adjacent column.
Standards Applied
A section of the technical file must identify and list all the standards, specifications, and reference/guidance documents that apply to the product in question. It must be stated whether the listed documents have been applied in full or part, together with a justification if any standard or document listed has not been applied in full.
Design Verification Data
Design verification data, and in particular, if the product is electrical in nature, electrical safety and electromagnetic compatibility (EMC) compliance certificates must demonstrate that the latest versions of all applicable and necessary standards have been applied. Full validation of any software must also be provided.
Check back for follow-ups to this introduction piece for further insights into what critical information you need to have a product able to be released in both the U.S. and in the EU.
Bernard Tremaine is the former CEO of MDQAS Ltd. (1994 to August 2015). He has 40+ years experience in the healthcare industry, with half of this time being spent at MEI in Milwaukee, Wis, where Bernard held various positions in MEI’s European operations.