New Medical Device Regulations in the European Union

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New Medical Device Regulations in the European Union

Ever since the new EU medical device and IVD regulations were proposed in September 2012, the medical device industry has been attempting to gain a firm grasp on what they need to do to be compliant and prepared. There has been talk of unannounced notified body audits, of new requirements for clinical evidence, and a complete reformatting of the Medical Devices Directive. This year, 2014, is the goal year for the European Parliament to adopt the agreed upon regulations. So it is prudent to understand what these regulations are and what they mean to the medical device industry.

Change Happens, But Why?

The reason for the major overhaul of the existing Medical Devices Directive is two-fold. The first is a matter of adapting to the growth of the EU. The original EU Medical Device legislation was established over two decades ago, when the EU was substantially smaller. Over the past few decades, more and more countries have joined the union, and the existing legislation was no longer effectively overseeing the safety of devices and their free movement through the EU and International markets. (1)

The second reason for the change, which serves as evidence of the current legislation’s inability to regulate effectively, was the PIP breast implant scandal. Poly Implant Prothéses (PIP), an international supplier of breast implants based in France, was accused of using industrial silicone in their implants. The silicone, not meant for medical devices, would leak into women’s bodies when the implants ruptured (2).

This scandal motivated the EU Commission to issue a new proposal on the regulation of medical devices. The proposal would allow for greater oversight and accountability for medical devices and IVDs.

Major Renovations

Greater Responsibility For Notified Bodies

On September 24, 2013, the EU Commission released a recommendation specifying the requirements for Notified Bodies to conduct regular unannounced audits of any manufacturer or supplier of EC certified products (3). The audits will happen once every three years. The auditors will come to the manufacturer’s location and must be provided unrestricted access to the company. These are scheduled to be introduced in the first half of 2014. (4)

Not only will notified bodies be responsible for these audits, they will have to meet the European Commission’s new accreditation requirements for notified bodies. Some notified bodies may choose to close their doors, resulting in a change of notified body for manufacturers. Another change proposed by the EP will be that only special notified bodies will be certified to approve high risk (Class II, IIb) devices. As it currently stands any notified body has the ability to approve these devices, however if the proposal is adopted, a high risk device will have to go through a special notified body for approval. (5)

The Scope Of The Existing Directive Will Widen To Include:

  • Products manufactured using non-viable human tissues or cells, or their derivatives that have undergone substantial manipulation.
  • Certain implantable or other invasive products without a medical purpose that is similar to medical devices in terms of characteristics and risk profile. (6) For example, contact lenses, cosmetic implants and invasive laser equipment. (5)

Devices and products that may not have been regulated previously will now be subject to new levels of scrutiny and oversight. It is important to determine if your product may be required to comply with EU regulations. The commission has created a centralized classification mechanism. This is included in the new “Blue Guide (8)” which was recently published by the EU Commission. The guide details which products fall under regulation and the requirements for conformity.

Greater Clinical Trial Oversight and Clinical Evidence Requirements

This will be implemented through various channels, including requirements to register medical devices and clinical trials on the European Databank on Medical Devices (Eudamed). The database will also be used for adverse event and vigilance reporting by manufacturers.

Another possible requirement (that has yet to be adopted) is the mandatory use of the Randomized Controlled Investigation for clinical trials. If a sponsor wants to use another study design they will have to justify this to the member state Ethical Board. (7) Industry professionals agree that there will be more clinical trial requirements and companies will face higher investments if they wish to gain market approval. However the extent of this had yet to be determined. (5)

Manufacturers (and Authorized Representatives) must have a Qualified Person.

Each manufacturer must select an individual who is solely responsible for regulatory compliance, management of the technical file, declaration of conformity, and vigilance reporting. This person will have to meet qualification requirements as determined by the Commission. It has not yet specified whether this person can be a consultant or must be employed by the manufacturer. (5)

Expansion of Vigilance Reporting, Surveillance, and Supply Chain Compliance

changesAs stated before, Vigilance reports will be made in an EU database (part of Eudamed). One particular aspect that is important to manufacturers is that the definition for a reportable incident will change. The suggested definition is:

any incident that directly or indirectly led, might have led or might lead to death of a patient, user or other person, temporary or permanent serious deterioration of the patient’s, user’s or other person’s state of health, serious public health threat. (9)

Manufacturers will need to re-examine their plan for vigilance reporting to ensure it includes any incidents that meet this criteria.

A Supply chain compliance system is also being created. This means that a manufacturer is responsible for ensuring that suppliers have compliant SOPS and contracts. A distributor will have to verify that the importer is compliant. All companies involved in the supply chain will be responsible for verification of compliance for the company who handled the device before them and will be subject to unannounced audits. (5)

Time to Prepare

pic3With all of these new measures being taken to increase the safety, accountability, and traceability of medical devices, manufacturers must begin acting now so that they are not left unprepared and therefore, uncompliant. There will be a three-year transition period allowed for companies to obtain certification under the new rules, however competition for assessments by notified bodies will be fierce, so it is best to start the process now rather than later. There are several measures that companies can take to brace themselves for the impact once these proposals are adopted:

  1. Stay informed. This is the most important, as many of the proposals are still under debate. It is crucial to keep up-to-date on the possible changes that will be implemented by the EU Commission. (5)
  2. Reassess supply contracts (distribution, importer, Authorized Representative) to determine if they account for verifying compliance, vigilance reporting, and unannounced audits. (5)
  3. Perform a gap analysis on technical files, SOPs, and contracts to determine what needs to be done to be compliant with the new rules. (5)
  4. Determine whether more clinical data will be required for the device to be certifiable, and then gather this data before the conformity assessment. (5)

Preparing now for the upcoming changes in the EU medical device market will mean your company will be one step ahead of the game; however all of these changes can be difficult to track. Boston Biomedical Associates can assist your company in identifying changes that need to be made and implementing these changes successfully, without wasting resources. Please contact us at any time for more information.

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1. MHRA. New Legislation on Medical Devices. 2013.

2. Jacobsen, Henriette. EU at crossroads on new medical devices legislation. s.l. : EurActiv, 2013.

3. COMMISSION, THE EUROPEAN. COMMISSION RECOMMENDATION of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices. s.l. : Official Journal of the European Union, 2013.

4. The British Standards Institution. How BSI can support you with unannounced audits. 2013.

5. Gert Bos, Erik Vollebregt. The proposed EU regulations for medical and in vitro diagnostic devices. s.l. : bsi., 2014.

6. Brussels. REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002. s.l. : European Commission, 2012.

7. Vollebregt, Erik. Hold on to your seat: ENVI’s Dagmar Roth-Behrendt report is here. s.l. : medicaldeviceslegal, 2013.

8. European Commission. The ‘Blue Guide’on the implementation of EU product rules. 2014. Vols. Ref. Ares(2014)1025242 – 02/04/2014.

9. Wissenschaftliche Prüfungsarbeit, Dr. Ehrhard Anhalt, Dr. Heinrich Prinz. Obligation of Economic Operators, Traceability, Vigilance and Market Surveillance of Medical Devices as foreseen by the EU Commission Proposal for a Regulationof Medical Devices of 26 September 2012: Comparison with Existing Requirements and Evaluation. 2013.

Mack Rubley


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